National Toxicology Program

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TDMS Study 97006-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 05/11/04       
EXPERIMENT: 97006 TEST: 01                                                                                     TIME: 08:53:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 108-10-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 05/11/04       
EXPERIMENT: 97006 TEST: 01                                                                                     TIME: 08:53:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 108-10-1        
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 05/11/04       
EXPERIMENT: 97006 TEST: 01                                                                                     TIME: 08:53:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 108-10-1        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                 METHYL ISOBUTYL KETONE                                                                           
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Islets, Pancreatic                     Carcinoma or Adenoma                                                                         
Kidney: Renal Tubule                   Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Lung                                   Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Testes                                 Adenoma                                                                                      
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Kidney: Renal Tubule                   Mesenchymal Tumor Malignant                                                                  
Mammary Gland                          Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Uterus                                 Sarcoma Stromal or Polyp Stromal                                                             
All Organs                             Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                  METHYL ISOBUTYL KETONE   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   7/48 (15%)   10/50 (20%)  12/50 (24%) |3/50 (6%)    0/50 (0%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     8/44.85      7/40.55      10/42.79     12/43.38    |3/45.28      0/44.54      2/42.01      2/43.18      | 
|POLY-3 PERCENT (g) |     17.8%        17.3%        23.4%        27.7%       |6.6%         0.0%         4.8%         4.6%         | 
|TERMINAL (d)       |     6/32 (19%)   6/28 (21%)   5/25 (20%)   4/19 (21%)  |0/35 (0%)    0/34 (0%)    1/26 (4%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     671          654          637          609         |643          ---          714          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.019 *    P=0.603      P=0.244      P=0.057     |P=0.579      P=0.124N     P=0.613N     P=0.540N     | 
|POLY 3             |     P=0.120      P=0.585N     P=0.353      P=0.197     |P=0.590N     P=0.122N     P=0.534N     P=0.522N     | 
|POLY 1.5           |     P=0.130      P=0.567N     P=0.362      P=0.213     |P=0.585N     P=0.121N     P=0.517N     P=0.514N     | 
|POLY 6             |     P=0.099      P=0.605N     P=0.338      P=0.165     |P=0.597N     P=0.123N     P=0.563N     P=0.530N     | 
|LOGISTIC REGRESSION|     P=0.093      P=0.609N     P=0.328      P=0.193     |P=0.595N     P=0.120N     P=0.523N     P=0.512N     | 
|COCH-ARM / FISHERS |     P=0.135      P=0.535N     P=0.398      P=0.227     |P=0.577N     P=0.121N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.187      (e)          (e)          (e)         |P=0.312N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/48 (4%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      2/40.60      1/42.07      2/41.33     |0/44.82      1/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.9%         2.4%         4.8%        |0.0%         2.3%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    1/25 (4%)    2/19 (11%)  |0/35 (0%)    1/34 (3%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          664          726 (T)      726 (T)     |---          727 (T)      727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.139      P=0.210      P=0.451      P=0.132     |P=0.616N     P=0.494      P=0.441      (e)          | 
|POLY 3             |     P=0.225      P=0.217      P=0.489      P=0.221     |P=0.606N     P=0.499      P=0.487      (e)          | 
|POLY 1.5           |     P=0.238      P=0.221      P=0.492      P=0.229     |P=0.602N     P=0.499      P=0.494      (e)          | 
|POLY 6             |     P=0.200      P=0.214      P=0.484      P=0.205     |P=0.610N     P=0.499      P=0.475      (e)          | 
|LOGISTIC REGRESSION|     P=0.204      P=0.226      P=0.451      P=0.132     |(e)          P=0.494      P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.250      P=0.237      P=0.500      P=0.247     |P=0.595N     P=0.500      P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.143      (e)          (e)          (e)         |P=0.394      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/50 (16%)   9/48 (19%)   11/50 (22%)  14/50 (28%) |3/50 (6%)    1/50 (2%)    3/50 (6%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     8/44.85      9/40.87      11/42.79     14/43.38    |3/45.28      1/44.54      3/42.01      2/43.18      | 
|POLY-3 PERCENT (g) |     17.8%        22.0%        25.7%        32.3%       |6.6%         2.3%         7.1%         4.6%         | 
|TERMINAL (d)       |     6/32 (19%)   6/28 (21%)   6/25 (24%)   6/19 (32%)  |0/35 (0%)    1/34 (3%)    2/26 (8%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     671          654          637          609         |643          727 (T)      714          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.007 **   P=0.376      P=0.169      P=0.017 *   |P=0.575N     P=0.311N     P=0.535      P=0.540N     | 
|POLY 3             |     P=0.062      P=0.415      P=0.262      P=0.090     |P=0.543N     P=0.311N     P=0.627      P=0.522N     | 
|POLY 1.5           |     P=0.071      P=0.432      P=0.272      P=0.102     |P=0.535N     P=0.309N     P=0.645      P=0.514N     | 
|POLY 6             |     P=0.047 *    P=0.400      P=0.248      P=0.069     |P=0.552N     P=0.314N     P=0.597      P=0.530N     | 
|LOGISTIC REGRESSION|     P=0.046 *    P=0.392      P=0.238      P=0.082     |P=0.548N     P=0.305N     P=0.630      P=0.512N     | 
|COCH-ARM / FISHERS |     P=0.077      P=0.463      P=0.306      P=0.114     |P=0.523N     P=0.309N     P=0.661N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.080      (e)          (e)          (e)         |P=0.527N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    0/49 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    3/50 (6%)    1/50 (2%)    3/50 (6%)    | 
|POLY-3 RATE (b)    |     1/44.48      0/41.12      1/42.07      0/41.33     |1/44.82      3/44.54      1/41.95      3/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         0.0%         2.4%         0.0%        |2.2%         6.7%         2.4%         7.0%         | 
|TERMINAL (d)       |     1/32 (3%)    0/28 (0%)    1/25 (4%)    0/19 (0%)   |1/35 (3%)    3/34 (9%)    1/26 (4%)    3/32 (9%)    | 
|FIRST INCIDENCE    |     726 (T)      ---          726 (T)      ---         |727 (T)      727 (T)      727 (T)      727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.508N     P=0.527N     P=0.706      P=0.604N    |P=0.272      P=0.294      P=0.694      P=0.273      | 
|POLY 3             |     P=0.409N     P=0.516N     P=0.748      P=0.515N    |P=0.295      P=0.303      P=0.746      P=0.292      | 
|POLY 1.5           |     P=0.405N     P=0.512N     P=0.751      P=0.507N    |P=0.302      P=0.304      P=0.753      P=0.296      | 
|POLY 6             |     P=0.418N     P=0.520N     P=0.743      P=0.530N    |P=0.288      P=0.303      P=0.733      P=0.288      | 
|LOGISTIC REGRESSION|     P=0.508N     (e)          P=0.706      (e)         |P=0.272      P=0.294      P=0.694      P=0.273      | 
|COCH-ARM / FISHERS |     P=0.404N     P=0.505N     P=0.753N     P=0.500N    |P=0.313      P=0.309      P=0.753N     P=0.309      | 
|ORDER RESTRICTED   |     P=0.266N     (e)          (e)          (e)         |P=0.229      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    4/48 (8%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/45.04      4/40.28      1/42.13      1/41.60     |0/44.82      0/44.54      0/41.95      1/43.18      | 
|POLY-3 PERCENT (g) |     6.7%         9.9%         2.4%         2.4%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     2/32 (6%)    4/28 (14%)   0/25 (0%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     554          726 (T)      713          652         |---          ---          ---          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.253N     P=0.434      P=0.378N     P=0.420N    |P=0.192      (e)          (e)          P=0.482      | 
|POLY 3             |     P=0.152N     P=0.439      P=0.329N     P=0.334N    |P=0.194      (e)          (e)          P=0.493      | 
|POLY 1.5           |     P=0.143N     P=0.453      P=0.323N     P=0.319N    |P=0.196      (e)          (e)          P=0.495      | 
|POLY 6             |     P=0.169N     P=0.423      P=0.340N     P=0.363N    |P=0.193      (e)          (e)          P=0.491      | 
|LOGISTIC REGRESSION|     P=0.147N     P=0.450      P=0.303N     P=0.286N    |(e)          (e)          (e)          P=0.482      | 
|COCH-ARM / FISHERS |     P=0.134N     P=0.477      P=0.309N     P=0.309N    |P=0.198      (e)          (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.172N     (e)          (e)          (e)         |P=0.114      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    2/48 (4%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/44.58      2/40.28      2/42.56      1/41.33     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     9.0%         5.0%         4.7%         2.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/32 (9%)    2/28 (7%)    1/25 (4%)    1/19 (5%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     701          726 (T)      580          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.260N     P=0.404N     P=0.434N     P=0.358N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.145N     P=0.385N     P=0.358N     P=0.202N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.139N     P=0.375N     P=0.354N     P=0.190N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.160N     P=0.396N     P=0.367N     P=0.228N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.164N     P=0.407N     P=0.355N     P=0.307N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.134N     P=0.359N     P=0.339N     P=0.181N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.135N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/50 (14%)   6/48 (13%)   3/50 (6%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     7/45.14      6/40.28      3/42.62      2/41.60     |0/44.82      0/44.54      0/41.95      1/43.18      | 
|POLY-3 PERCENT (g) |     15.5%        14.9%        7.0%         4.8%        |0.0%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     5/32 (16%)   6/28 (21%)   1/25 (4%)    1/19 (5%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     554          726 (T)      580          652         |---          ---          ---          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.131N     P=0.600N     P=0.255N     P=0.222N    |P=0.192      (e)          (e)          P=0.482      | 
|POLY 3             |     P=0.045N*    P=0.588N     P=0.181N     P=0.099N    |P=0.194      (e)          (e)          P=0.493      | 
|POLY 1.5           |     P=0.041N*    P=0.567N     P=0.176N     P=0.088N    |P=0.196      (e)          (e)          P=0.495      | 
|POLY 6             |     P=0.056N     P=0.612N     P=0.190N     P=0.121N    |P=0.193      (e)          (e)          P=0.491      | 
|LOGISTIC REGRESSION|     P=0.049N*    P=0.591N     P=0.167N     P=0.092N    |(e)          (e)          (e)          P=0.482      | 
|COCH-ARM / FISHERS |     P=0.038N*    P=0.532N     P=0.159N     P=0.080N    |P=0.198      (e)          (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.075N     (e)          (e)          (e)         |P=0.114      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.74      2/42.20      3/41.36     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.7%         7.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    1/25 (4%)    2/19 (11%)  |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          695          719         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.008 **   (e)          P=0.204      P=0.049 *   |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.024 *    (e)          P=0.225      P=0.106     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.026 *    (e)          P=0.228      P=0.113     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.020 *    (e)          P=0.221      P=0.094     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.012 *    (e)          P=0.219      P=0.052     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.028 *    (e)          P=0.247      P=0.121     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.031 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      1/41.74      0/42.07      2/41.33     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         4.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    1/28 (4%)    0/25 (0%)    2/19 (11%)  |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      ---          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.069      P=0.473      (e)          P=0.132     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.129      P=0.487      (e)          P=0.221     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.134      P=0.492      (e)          P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.119      P=0.482      (e)          P=0.205     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.473      (e)          P=0.132     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.140      P=0.500      (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.064      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      1/41.74      2/42.20      4/41.36     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         4.7%         9.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    1/28 (4%)    1/25 (4%)    3/19 (16%)  |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          726 (T)      695          719         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.004 **   P=0.473      P=0.204      P=0.018 *   |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.018 *    P=0.487      P=0.225      P=0.051     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.020 *    P=0.492      P=0.228      P=0.056     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.014 *    P=0.482      P=0.221      P=0.043 *   |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.007 **   P=0.473      P=0.219      P=0.018 *   |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.022 *    P=0.500      P=0.247      P=0.059     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.015 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Mesenchymal Tumor Malignant                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.74      0/42.07      0/41.33     |0/44.82      0/44.54      0/41.95      2/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.6%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    0/25 (0%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.219      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.043 *    (e)          (e)          P=0.229      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.232      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.043 *    (e)          (e)          P=0.227      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.219      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.027 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.12      0/42.07      2/41.33     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    0/25 (0%)    2/19 (11%)  |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          726 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.020 *    (e)          (e)          P=0.132     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.044 *    (e)          (e)          P=0.221     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.229     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.041 *    (e)          (e)          P=0.205     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.132     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.024 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.12      0/42.07      2/41.33     |1/44.82      1/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.8%        |2.2%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    0/25 (0%)    2/19 (11%)  |1/35 (3%)    1/34 (3%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          726 (T)     |727 (T)      727 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.020 *    (e)          (e)          P=0.132     |P=0.260N     P=0.755      P=0.559N     P=0.518N     | 
|POLY 3             |     P=0.044 *    (e)          (e)          P=0.221     |P=0.242N     P=0.759      P=0.513N     P=0.507N     | 
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.229     |P=0.239N     P=0.759      P=0.506N     P=0.505N     | 
|POLY 6             |     P=0.041 *    (e)          (e)          P=0.205     |P=0.246N     P=0.760      P=0.525N     P=0.509N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.132     |P=0.260N     P=0.755      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.247     |P=0.236N     P=0.753N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.024 *    (e)          (e)          (e)         |P=0.257N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/49 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      2/42.58      0/42.07      0/41.33     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    0/25 (0%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          338          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.404N     P=0.237      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.422N     P=0.227      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.414N     P=0.229      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.438N     P=0.224      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.363N     P=0.525      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.404N     P=0.242      (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.254N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |5/50 (10%)   8/50 (16%)   6/50 (12%)   4/50 (8%)    | 
|POLY-3 RATE (b)    |     2/44.48      1/41.74      0/42.07      1/41.33     |5/45.24      8/46.32      6/42.43      4/43.18      | 
|POLY-3 PERCENT (g) |     4.5%         2.4%         0.0%         2.4%        |11.1%        17.3%        14.1%        9.3%         | 
|TERMINAL (d)       |     2/32 (6%)    1/28 (4%)    0/25 (0%)    1/19 (5%)   |4/35 (11%)   3/34 (9%)    4/26 (15%)   4/32 (13%)   | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      ---          726 (T)     |606          539          653          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.511N     P=0.547N     P=0.294N     P=0.679N    |P=0.390N     P=0.270      P=0.329      P=0.553N     | 
|POLY 3             |     P=0.370N     P=0.522N     P=0.250N     P=0.526N    |P=0.357N     P=0.291      P=0.455      P=0.529N     | 
|POLY 1.5           |     P=0.369N     P=0.514N     P=0.247N     P=0.512N    |P=0.340N     P=0.284      P=0.478      P=0.519N     | 
|POLY 6             |     P=0.374N     P=0.532N     P=0.255N     P=0.552N    |P=0.377N     P=0.302      P=0.418      P=0.539N     | 
|LOGISTIC REGRESSION|     P=0.511N     P=0.547N     (e)          P=0.679N    |P=0.323N     P=0.280      P=0.449      P=0.526N     | 
|COCH-ARM / FISHERS |     P=0.366N     P=0.500N     P=0.247N     P=0.500N    |P=0.313N     P=0.277      P=0.500      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.249N     (e)          (e)          (e)         |P=0.391N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    1/50 (2%)   |22/50 (44%)  19/50 (38%)  25/50 (50%)  18/50 (36%)  | 
|POLY-3 RATE (b)    |     2/44.48      2/41.74      2/42.30      1/41.33     |22/45.39     19/46.07     25/45.07     18/44.04     | 
|POLY-3 PERCENT (g) |     4.5%         4.8%         4.7%         2.4%        |48.5%        41.2%        55.5%        40.9%        | 
|TERMINAL (d)       |     2/32 (6%)    2/28 (7%)    1/25 (4%)    1/19 (5%)   |18/35 (51%)  13/34 (38%)  16/26 (62%)  15/32 (47%)  | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      667          726 (T)     |650          539          546          499          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.557N     P=0.647      P=0.617      P=0.679N    |P=0.494N     P=0.378N     P=0.064      P=0.392N     | 
|POLY 3             |     P=0.396N     P=0.671      P=0.676      P=0.526N    |P=0.371N     P=0.312N     P=0.321      P=0.303N     | 
|POLY 1.5           |     P=0.384N     P=0.679      P=0.680      P=0.512N    |P=0.348N     P=0.327N     P=0.337      P=0.291N     | 
|POLY 6             |     P=0.422N     P=0.661      P=0.669      P=0.552N    |P=0.400N     P=0.291N     P=0.290      P=0.315N     | 
|LOGISTIC REGRESSION|     P=0.479N     P=0.647      P=0.667      P=0.679N    |P=0.380N     P=0.349N     P=0.224      P=0.327N     | 
|COCH-ARM / FISHERS |     P=0.373N     P=0.691N     P=0.691N     P=0.500N    |P=0.314N     P=0.342N     P=0.344      P=0.270N     | 
|ORDER RESTRICTED   |     P=0.474N     (e)          (e)          (e)         |P=0.369N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |26/50 (52%)  24/50 (48%)  29/50 (58%)  21/50 (42%)  | 
|POLY-3 RATE (b)    |     4/44.48      3/41.74      2/42.30      2/41.33     |26/45.81     24/47.04     29/45.34     21/44.04     | 
|POLY-3 PERCENT (g) |     9.0%         7.2%         4.7%         4.8%        |56.8%        51.0%        64.0%        47.7%        | 
|TERMINAL (d)       |     4/32 (13%)   3/28 (11%)   1/25 (4%)    2/19 (11%)  |21/35 (60%)  16/34 (47%)  19/26 (73%)  18/32 (56%)  | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      667          726 (T)     |606          539          546          499          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.464N     P=0.574N     P=0.443N     P=0.593N    |P=0.420N     P=0.467N     P=0.046 *    P=0.340N     | 
|POLY 3             |     P=0.267N     P=0.535N     P=0.360N     P=0.371N    |P=0.300N     P=0.363N     P=0.308      P=0.254N     | 
|POLY 1.5           |     P=0.257N     P=0.522N     P=0.356N     P=0.353N    |P=0.266N     P=0.390N     P=0.330      P=0.237N     | 
|POLY 6             |     P=0.289N     P=0.551N     P=0.369N     P=0.408N    |P=0.348N     P=0.326N     P=0.269      P=0.276N     | 
|LOGISTIC REGRESSION|     P=0.393N     P=0.574N     P=0.386N     P=0.593N    |P=0.281N     P=0.431N     P=0.211      P=0.265N     | 
|COCH-ARM / FISHERS |     P=0.248N     P=0.500N     P=0.339N     P=0.339N    |P=0.222N     P=0.421N     P=0.344      P=0.212N     | 
|ORDER RESTRICTED   |     P=0.340N     (e)          (e)          (e)         |P=0.285N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     35/50 (70%)  29/49 (59%)  30/50 (60%)  29/50 (58%) |24/49 (49%)  28/50 (56%)  26/50 (52%)  30/50 (60%)  | 
|POLY-3 RATE (b)    |     35/48.31     29/43.65     30/44.72     29/45.88    |24/45.40     28/48.76     26/47.26     30/45.79     | 
|POLY-3 PERCENT (g) |     72.5%        66.4%        67.1%        63.2%       |52.9%        57.4%        55.0%        65.5%        | 
|TERMINAL (d)       |     21/32 (66%)  20/28 (71%)  16/25 (64%)  12/19 (63%) |16/34 (47%)  17/34 (50%)  10/26 (39%)  20/32 (63%)  | 
|FIRST INCIDENCE    |     492          595          580          498         |606          455          513          489          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.140      P=0.444N     P=0.494      P=0.218     |P=0.128      P=0.307      P=0.160      P=0.133      | 
|POLY 3             |     P=0.207N     P=0.341N     P=0.365N     P=0.222N    |P=0.141      P=0.406      P=0.500      P=0.150      | 
|POLY 1.5           |     P=0.179N     P=0.275N     P=0.317N     P=0.181N    |P=0.157      P=0.366      P=0.491      P=0.158      | 
|POLY 6             |     P=0.281N     P=0.416N     P=0.428N     P=0.311N    |P=0.130      P=0.450      P=0.499      P=0.149      | 
|LOGISTIC REGRESSION|     P=0.218N     P=0.251N     P=0.276N     P=0.168N    |P=0.181      P=0.309      P=0.453      P=0.139      | 
|COCH-ARM / FISHERS |     P=0.169N     P=0.180N     P=0.201N     P=0.149N    |P=0.192      P=0.309      P=0.460      P=0.184      | 
|ORDER RESTRICTED   |     P=0.250N     (e)          (e)          (e)         |P=0.172      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     35/50 (70%)  29/49 (59%)  30/50 (60%)  29/50 (58%) |24/49 (49%)  28/50 (56%)  27/50 (54%)  30/50 (60%)  | 
|POLY-3 RATE (b)    |     35/48.31     29/43.65     30/44.72     29/45.88    |24/45.40     28/48.76     27/47.26     30/45.79     | 
|POLY-3 PERCENT (g) |     72.5%        66.4%        67.1%        63.2%       |52.9%        57.4%        57.1%        65.5%        | 
|TERMINAL (d)       |     21/32 (66%)  20/28 (71%)  16/25 (64%)  12/19 (63%) |16/34 (47%)  17/34 (50%)  10/26 (39%)  20/32 (63%)  | 
|FIRST INCIDENCE    |     492          595          580          498         |606          455          513          489          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.140      P=0.444N     P=0.494      P=0.218     |P=0.125      P=0.307      P=0.123      P=0.133      | 
|POLY 3             |     P=0.207N     P=0.341N     P=0.365N     P=0.222N    |P=0.135      P=0.406      P=0.419      P=0.150      | 
|POLY 1.5           |     P=0.179N     P=0.275N     P=0.317N     P=0.181N    |P=0.150      P=0.366      P=0.410      P=0.158      | 
|POLY 6             |     P=0.281N     P=0.416N     P=0.428N     P=0.311N    |P=0.124      P=0.450      P=0.416      P=0.149      | 
|LOGISTIC REGRESSION|     P=0.218N     P=0.251N     P=0.276N     P=0.168N    |P=0.173      P=0.309      P=0.371      P=0.139      | 
|COCH-ARM / FISHERS |     P=0.169N     P=0.180N     P=0.201N     P=0.149N    |P=0.185      P=0.309      P=0.383      P=0.184      | 
|ORDER RESTRICTED   |     P=0.250N     (e)          (e)          (e)         |P=0.171      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      1/42.00      2/42.07      1/41.33     |0/44.82      1/44.62      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         4.8%         2.4%        |0.0%         2.2%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    2/25 (8%)    1/19 (5%)   |0/35 (0%)    0/34 (0%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          659          726 (T)      726 (T)     |---          707          727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.245      P=0.469      P=0.185      P=0.396     |P=0.624N     P=0.505      P=0.441      (e)          | 
|POLY 3             |     P=0.335      P=0.489      P=0.225      P=0.485     |P=0.606N     P=0.499      P=0.487      (e)          | 
|POLY 1.5           |     P=0.353      P=0.493      P=0.228      P=0.493     |P=0.602N     P=0.499      P=0.494      (e)          | 
|POLY 6             |     P=0.301      P=0.484      P=0.219      P=0.470     |P=0.610N     P=0.500      P=0.475      (e)          | 
|LOGISTIC REGRESSION|     P=0.320      P=0.516      P=0.185      P=0.396     |P=0.608N     P=0.499      P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.366      P=0.500      P=0.247      P=0.500     |P=0.595N     P=0.500      P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.213      (e)          (e)          (e)         |P=0.395      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     4/44.48      1/41.74      2/42.07      2/41.36     |0/44.82      0/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     9.0%         2.4%         4.8%         4.8%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     4/32 (13%)   1/28 (4%)    2/25 (8%)    1/19 (5%)   |0/35 (0%)    0/34 (0%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      726 (T)      719         |---          ---          727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.565N     P=0.220N     P=0.455N     P=0.590N    |P=0.675      (e)          P=0.441      (e)          | 
|POLY 3             |     P=0.354N     P=0.198N     P=0.363N     P=0.371N    |P=0.683      (e)          P=0.487      (e)          | 
|POLY 1.5           |     P=0.347N     P=0.191N     P=0.357N     P=0.353N    |P=0.686      (e)          P=0.494      (e)          | 
|POLY 6             |     P=0.372N     P=0.207N     P=0.374N     P=0.407N    |P=0.683      (e)          P=0.475      (e)          | 
|LOGISTIC REGRESSION|     P=0.552N     P=0.220N     P=0.455N     P=0.573N    |(e)          (e)          P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.343N     P=0.181N     P=0.339N     P=0.339N    |P=0.694      (e)          P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.238N     (e)          (e)          (e)         |P=0.368      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/50 (10%)   4/50 (8%)    2/50 (4%)    4/50 (8%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     5/44.48      4/42.63      2/42.07      4/41.44     |0/44.82      1/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     11.2%        9.4%         4.8%         9.7%        |0.0%         2.3%         2.4%         0.0%         | 
|TERMINAL (d)       |     5/32 (16%)   2/28 (7%)    2/25 (8%)    2/19 (11%)  |0/35 (0%)    1/34 (3%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      471          726 (T)      705         |---          727 (T)      727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.475      P=0.581N     P=0.323N     P=0.468     |P=0.616N     P=0.494      P=0.441      (e)          | 
|POLY 3             |     P=0.439N     P=0.527N     P=0.239N     P=0.544N    |P=0.606N     P=0.499      P=0.487      (e)          | 
|POLY 1.5           |     P=0.424N     P=0.517N     P=0.234N     P=0.521N    |P=0.602N     P=0.499      P=0.494      (e)          | 
|POLY 6             |     P=0.469N     P=0.538N     P=0.248N     P=0.590N    |P=0.610N     P=0.499      P=0.475      (e)          | 
|LOGISTIC REGRESSION|     P=0.472N     P=0.520N     P=0.323N     P=0.516     |(e)          P=0.494      P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.410N     P=0.500N     P=0.218N     P=0.500N    |P=0.595N     P=0.500      P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.401N     (e)          (e)          (e)         |P=0.394      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/44.48      2/41.90      0/42.07      0/41.33     |0/44.82      1/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.8%         0.0%         0.0%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/32 (3%)    1/28 (4%)    0/25 (0%)    0/19 (0%)   |0/35 (0%)    1/34 (3%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      685          ---          ---         |---          727 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.264N     P=0.446      P=0.549N     P=0.604N    |P=0.583N     P=0.494      (e)          (e)          | 
|POLY 3             |     P=0.200N     P=0.479      P=0.511N     P=0.515N    |P=0.574N     P=0.499      (e)          (e)          | 
|POLY 1.5           |     P=0.195N     P=0.487      P=0.508N     P=0.507N    |P=0.571N     P=0.499      (e)          (e)          | 
|POLY 6             |     P=0.210N     P=0.470      P=0.516N     P=0.530N    |P=0.579N     P=0.499      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.217N     P=0.466      (e)          (e)         |(e)          P=0.494      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.188N     P=0.500      P=0.500N     P=0.500N    |P=0.567N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.170N     (e)          (e)          (e)         |P=0.386N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/44.48      3/42.63      0/42.07      2/41.41     |0/44.82      1/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         7.0%         0.0%         4.8%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/32 (3%)    1/28 (4%)    0/25 (0%)    1/19 (5%)   |0/35 (0%)    1/34 (3%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      471          ---          705         |---          727 (T)      ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.424      P=0.264      P=0.549N     P=0.337     |P=0.583N     P=0.494      (e)          (e)          | 
|POLY 3             |     P=0.527      P=0.290      P=0.511N     P=0.475     |P=0.574N     P=0.499      (e)          (e)          | 
|POLY 1.5           |     P=0.541      P=0.295      P=0.508N     P=0.488     |P=0.571N     P=0.499      (e)          (e)          | 
|POLY 6             |     P=0.500      P=0.283      P=0.516N     P=0.449     |P=0.579N     P=0.499      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.558      P=0.339      (e)          P=0.378     |(e)          P=0.494      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.556      P=0.309      P=0.500N     P=0.500     |P=0.567N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.407      (e)          (e)          (e)         |P=0.386N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.74      2/42.07      0/41.33     |0/44.82      0/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.8%         0.0%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    2/25 (8%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |---          ---          727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.492      (e)          P=0.185      (e)         |P=0.675      (e)          P=0.441      (e)          | 
|POLY 3             |     P=0.566      (e)          P=0.225      (e)         |P=0.683      (e)          P=0.487      (e)          | 
|POLY 1.5           |     P=0.584      (e)          P=0.228      (e)         |P=0.686      (e)          P=0.494      (e)          | 
|POLY 6             |     P=0.526      (e)          P=0.219      (e)         |P=0.683      (e)          P=0.475      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.185      (e)         |(e)          (e)          P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.694      (e)          P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.237      (e)          (e)          (e)         |P=0.368      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.48      0/41.74      2/42.07      0/41.33     |0/44.82      0/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.8%         0.0%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    2/25 (8%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          726 (T)      ---         |---          ---          727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.492      (e)          P=0.185      (e)         |P=0.675      (e)          P=0.441      (e)          | 
|POLY 3             |     P=0.566      (e)          P=0.225      (e)         |P=0.683      (e)          P=0.487      (e)          | 
|POLY 1.5           |     P=0.584      (e)          P=0.228      (e)         |P=0.686      (e)          P=0.494      (e)          | 
|POLY 6             |     P=0.526      (e)          P=0.219      (e)         |P=0.683      (e)          P=0.475      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.185      (e)         |(e)          (e)          P=0.441      (e)          | 
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.694      (e)          P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.237      (e)          (e)          (e)         |P=0.368      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     42/50 (84%)  42/50 (84%)  44/50 (88%)  48/50 (96%) |                                                    | 
|POLY-3 RATE (b)    |     42/48.54     42/46.51     44/46.60     48/49.20    |                                                    | 
|POLY-3 PERCENT (g) |     86.5%        90.3%        94.4%        97.6%       |                                                    | 
|TERMINAL (d)       |     29/32 (91%)  26/28 (93%)  25/25 (100%) 19/19 (100%)|                                                    | 
|FIRST INCIDENCE    |     468          471          539          498         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.227      P=0.060      P<0.001 **  |                                                    | 
|POLY 3             |     P=0.015 *    P=0.393      P=0.149      P=0.036 *   |                                                    | 
|POLY 1.5           |     P=0.017 *    P=0.463      P=0.183      P=0.040 *   |                                                    | 
|POLY 6             |     P=0.013 *    P=0.344      P=0.124      P=0.032 *   |                                                    | 
|LOGISTIC REGRESSION|     P=0.018 *    P=0.435      P=0.212      P=0.036 *   |                                                    | 
|COCH-ARM / FISHERS |     P=0.028 *    P=0.607N     P=0.387      P=0.046 *   |                                                    | 
|ORDER RESTRICTED   |     P=0.014 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    4/48 (8%)    0/50 (0%)    4/50 (8%)   |3/50 (6%)    2/50 (4%)    2/50 (4%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     1/44.48      4/40.28      0/42.07      4/41.53     |3/44.82      2/44.54      2/42.23      2/43.46      | 
|POLY-3 PERCENT (g) |     2.3%         9.9%         0.0%         9.6%        |6.7%         4.5%         4.7%         4.6%         | 
|TERMINAL (d)       |     1/32 (3%)    4/28 (14%)   0/25 (0%)    3/19 (16%)  |3/35 (9%)    2/34 (6%)    1/26 (4%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     726 (T)      726 (T)      ---          674         |727 (T)      727 (T)      653          651          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.087      P=0.139      P=0.549N     P=0.067     |P=0.475N     P=0.513N     P=0.621N     P=0.530N     | 
|POLY 3             |     P=0.206      P=0.149      P=0.511N     P=0.158     |P=0.446N     P=0.503N     P=0.527N     P=0.514N     | 
|POLY 1.5           |     P=0.218      P=0.155      P=0.508N     P=0.169     |P=0.441N     P=0.502N     P=0.513N     P=0.510N     | 
|POLY 6             |     P=0.185      P=0.143      P=0.516N     P=0.138     |P=0.451N     P=0.502N     P=0.550N     P=0.516N     | 
|LOGISTIC REGRESSION|     P=0.121      P=0.139      (e)          P=0.099     |P=0.454N     P=0.513N     P=0.557N     P=0.518N     | 
|COCH-ARM / FISHERS |     P=0.232      P=0.168      P=0.500N     P=0.181     |P=0.431N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.092      (e)          (e)          (e)         |P=0.517N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/50 (4%)    3/48 (6%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)    | 
|POLY-3 RATE (b)    |     2/44.48      3/40.53      0/42.07      1/41.65     |1/44.82      1/44.54      1/42.26      2/43.20      | 
|POLY-3 PERCENT (g) |     4.5%         7.4%         0.0%         2.4%        |2.2%         2.3%         2.4%         4.6%         | 
|TERMINAL (d)       |     2/32 (6%)    2/28 (7%)    0/25 (0%)    0/19 (0%)   |1/35 (3%)    1/34 (3%)    0/26 (0%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     726 (T)      658          ---          638         |727 (T)      727 (T)      642          723          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.356N     P=0.440      P=0.294N     P=0.625N    |P=0.329      P=0.755      P=0.713      P=0.476      | 
|POLY 3             |     P=0.254N     P=0.458      P=0.250N     P=0.523N    |P=0.338      P=0.759      P=0.748      P=0.487      | 
|POLY 1.5           |     P=0.247N     P=0.466      P=0.247N     P=0.511N    |P=0.343      P=0.759      P=0.754      P=0.491      | 
|POLY 6             |     P=0.267N     P=0.450      P=0.255N     P=0.547N    |P=0.334      P=0.760      P=0.736      P=0.484      | 
|LOGISTIC REGRESSION|     P=0.258N     P=0.444      (e)          P=0.524N    |P=0.336      P=0.755      P=0.762N     P=0.476      | 
|COCH-ARM / FISHERS |     P=0.239N     P=0.480      P=0.247N     P=0.500N    |P=0.351      P=0.753N     P=0.753N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.183N     (e)          (e)          (e)         |P=0.397      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    7/48 (15%)   0/50 (0%)    5/50 (10%)  |4/50 (8%)    3/50 (6%)    3/50 (6%)    4/50 (8%)    | 
|POLY-3 RATE (b)    |     3/44.48      7/40.53      0/42.07      5/41.85     |4/44.82      3/44.54      3/42.54      4/43.48      | 
|POLY-3 PERCENT (g) |     6.7%         17.3%        0.0%         12.0%       |8.9%         6.7%         7.1%         9.2%         | 
|TERMINAL (d)       |     3/32 (9%)    6/28 (21%)   0/25 (0%)    3/19 (16%)  |4/35 (11%)   3/34 (9%)    1/26 (4%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     726 (T)      658          ---          638         |727 (T)      727 (T)      642          651          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.266      P=0.108      P=0.167N     P=0.153     |P=0.485      P=0.516N     P=0.634N     P=0.605      | 
|POLY 3             |     P=0.490      P=0.120      P=0.129N     P=0.322     |P=0.518      P=0.503N     P=0.529N     P=0.627      | 
|POLY 1.5           |     P=0.507      P=0.128      P=0.126N     P=0.341     |P=0.525      P=0.503N     P=0.514N     P=0.631      | 
|POLY 6             |     P=0.455      P=0.113      P=0.133N     P=0.288     |P=0.513      P=0.503N     P=0.553N     P=0.625      | 
|LOGISTIC REGRESSION|     P=0.410      P=0.103      (e)          P=0.257     |P=0.509      P=0.516N     P=0.540N     P=0.619      | 
|COCH-ARM / FISHERS |     P=0.526      P=0.142      P=0.121N     P=0.357     |P=0.537      P=0.500N     P=0.500N     P=0.643N     | 
|ORDER RESTRICTED   |     P=0.262N     (e)          (e)          (e)         |P=0.607      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/48 (4%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/44.48      2/40.47      2/42.17      0/41.33     |0/44.82      0/44.54      0/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.9%         4.7%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/32 (3%)    1/28 (4%)    1/25 (4%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      677          702          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.427N     P=0.444      P=0.426      P=0.604N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.320N     P=0.467      P=0.481      P=0.515N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.306N     P=0.473      P=0.486      P=0.507N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.349N     P=0.461      P=0.474      P=0.530N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.343N     P=0.460      P=0.457      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.293N     P=0.485      P=0.500      P=0.500N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.221N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/50 (2%)    2/48 (4%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     1/44.48      2/40.47      2/42.17      0/41.33     |1/44.82      0/44.54      1/41.95      0/43.18      | 
|POLY-3 PERCENT (g) |     2.3%         4.9%         4.7%         0.0%        |2.2%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     1/32 (3%)    1/28 (4%)    1/25 (4%)    0/19 (0%)   |1/35 (3%)    0/34 (0%)    1/26 (4%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     726 (T)      677          702          ---         |727 (T)      ---          727 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.427N     P=0.444      P=0.426      P=0.604N    |P=0.431N     P=0.506N     P=0.694      P=0.518N     | 
|POLY 3             |     P=0.320N     P=0.467      P=0.481      P=0.515N    |P=0.412N     P=0.501N     P=0.746      P=0.507N     | 
|POLY 1.5           |     P=0.306N     P=0.473      P=0.486      P=0.507N    |P=0.409N     P=0.501N     P=0.753      P=0.505N     | 
|POLY 6             |     P=0.349N     P=0.461      P=0.474      P=0.530N    |P=0.415N     P=0.501N     P=0.733      P=0.509N     | 
|LOGISTIC REGRESSION|     P=0.343N     P=0.460      P=0.457      (e)         |P=0.431N     (e)          P=0.694      (e)          | 
|COCH-ARM / FISHERS |     P=0.293N     P=0.485      P=0.500      P=0.500N    |P=0.405N     P=0.500N     P=0.753N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.221N     (e)          (e)          (e)         |P=0.258N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |12/50 (24%)  5/50 (10%)   8/50 (16%)   14/50 (28%)  | 
|POLY-3 RATE (b)    |                                                        |12/47.11     5/45.07      8/42.96      14/44.20     | 
|POLY-3 PERCENT (g) |                                                        |25.5%        11.1%        18.6%        31.7%        | 
|TERMINAL (d)       |                                                        |8/35 (23%)   3/34 (9%)    5/26 (19%)   12/32 (38%)  | 
|FIRST INCIDENCE    |                                                        |370          595          581          398          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.126      P=0.070N     P=0.424N     P=0.328      | 
|POLY 3             |                                                        |P=0.139      P=0.063N     P=0.299N     P=0.336      | 
|POLY 1.5           |                                                        |P=0.152      P=0.060N     P=0.265N     P=0.362      | 
|POLY 6             |                                                        |P=0.124      P=0.066N     P=0.351N     P=0.310      | 
|LOGISTIC REGRESSION|                                                        |P=0.175      P=0.051N     P=0.201N     P=0.421      | 
|COCH-ARM / FISHERS |                                                        |P=0.175      P=0.054N     P=0.227N     P=0.410      | 
|ORDER RESTRICTED   |                                                        |P=0.089      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |13/50 (26%)  5/50 (10%)   8/50 (16%)   15/50 (30%)  | 
|POLY-3 RATE (b)    |                                                        |13/47.11     5/45.07      8/42.96      15/44.32     | 
|POLY-3 PERCENT (g) |                                                        |27.6%        11.1%        18.6%        33.8%        | 
|TERMINAL (d)       |                                                        |9/35 (26%)   3/34 (9%)    5/26 (19%)   12/32 (38%)  | 
|FIRST INCIDENCE    |                                                        |370          595          581          398          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.116      P=0.046N*    P=0.348N     P=0.325      | 
|POLY 3             |                                                        |P=0.130      P=0.039N*    P=0.224N     P=0.337      | 
|POLY 1.5           |                                                        |P=0.142      P=0.037N*    P=0.195N     P=0.363      | 
|POLY 6             |                                                        |P=0.117      P=0.041N*    P=0.271N     P=0.313      | 
|LOGISTIC REGRESSION|                                                        |P=0.163      P=0.032N*    P=0.145N     P=0.419      | 
|COCH-ARM / FISHERS |                                                        |P=0.164      P=0.033N*    P=0.163N     P=0.412      | 
|ORDER RESTRICTED   |                                                        |P=0.065      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR 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)    |     1/44.95      0/41.74      0/42.07      2/41.78     |0/44.82      0/44.54      2/42.26      1/43.18      | 
|POLY-3 PERCENT (g) |     2.2%         0.0%         0.0%         4.8%        |0.0%         0.0%         4.7%         2.3%         | 
|TERMINAL (d)       |     0/32 (0%)    0/28 (0%)    0/25 (0%)    1/19 (5%)   |0/35 (0%)    0/34 (0%)    1/26 (4%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     588          ---          ---          595         |---          ---          642          727 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.218      P=0.504N     P=0.513N     P=0.451     |P=0.233      (e)          P=0.195      P=0.482      | 
|POLY 3             |     P=0.243      P=0.515N     P=0.513N     P=0.474     |P=0.233      (e)          P=0.224      P=0.493      | 
|POLY 1.5           |     P=0.245      P=0.509N     P=0.510N     P=0.488     |P=0.237      (e)          P=0.231      P=0.495      | 
|POLY 6             |     P=0.236      P=0.522N     P=0.519N     P=0.449     |P=0.231      (e)          P=0.213      P=0.491      | 
|LOGISTIC REGRESSION|     P=0.247      P=0.425N     P=0.443N     P=0.515     |P=0.240      (e)          P=0.238      P=0.482      | 
|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=0.116      (e)          (e)          (e)         |P=0.157      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     0/44.48      2/42.15      0/42.07      0/41.33     |2/45.97      0/44.54      0/41.95      1/43.94      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         0.0%         0.0%        |4.4%         0.0%         0.0%         2.3%         | 
|TERMINAL (d)       |     0/32 (0%)    1/28 (4%)    0/25 (0%)    0/19 (0%)   |0/35 (0%)    0/34 (0%)    0/26 (0%)    0/32 (0%)    | 
|FIRST INCIDENCE    |     ---          609          ---          ---         |454          ---          ---          454          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.452N     P=0.223      (e)          (e)         |P=0.465N     P=0.245N     P=0.243N     P=0.507N     | 
|POLY 3             |     P=0.427N     P=0.225      (e)          (e)         |P=0.462N     P=0.244N     P=0.258N     P=0.516N     | 
|POLY 1.5           |     P=0.418N     P=0.229      (e)          (e)         |P=0.461N     P=0.242N     P=0.248N     P=0.510N     | 
|POLY 6             |     P=0.444N     P=0.220      (e)          (e)         |P=0.466N     P=0.246N     P=0.274N     P=0.521N     | 
|LOGISTIC REGRESSION|     P=0.402N     P=0.246      (e)          (e)         |P=0.357N     P=0.206N     P=0.276N     P=0.359N     | 
|COCH-ARM / FISHERS |     P=0.405N     P=0.247      (e)          (e)         |P=0.461N     P=0.247N     P=0.247N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.252N     (e)          (e)          (e)         |P=0.144N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     25/50 (50%)  26/50 (52%)  32/50 (64%)  35/50 (70%) |14/50 (28%)  21/50 (42%)  12/50 (24%)  16/50 (32%)  | 
|POLY-3 RATE (b)    |     25/48.08     26/43.97     32/47.77     35/48.24    |14/46.16     21/47.33     12/43.44     16/45.69     | 
|POLY-3 PERCENT (g) |     52.0%        59.1%        67.0%        72.6%       |30.3%        44.4%        27.6%        35.0%        | 
|TERMINAL (d)       |     13/32 (41%)  16/28 (57%)  13/25 (52%)  9/19 (47%)  |9/35 (26%)   12/34 (35%)  6/26 (23%)   8/32 (25%)   | 
|FIRST INCIDENCE    |     468          595          205          544         |583          356          637          499          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.288      P=0.056      P=0.004 **  |P=0.454      P=0.119      P=0.486      P=0.336      | 
|POLY 3             |     P=0.016 *    P=0.314      P=0.096      P=0.027 *   |P=0.526N     P=0.115      P=0.480N     P=0.399      | 
|POLY 1.5           |     P=0.015 *    P=0.381      P=0.094      P=0.029 *   |P=0.513N     P=0.111      P=0.445N     P=0.402      | 
|POLY 6             |     P=0.017 *    P=0.247      P=0.095      P=0.024 *   |P=0.537N     P=0.120      P=0.536N     P=0.400      | 
|LOGISTIC REGRESSION|     P=0.014 *    P=0.436      P=0.129      P=0.054     |P=0.492N     P=0.105      P=0.450N     P=0.412      | 
|COCH-ARM / FISHERS |     P=0.014 *    P=0.500      P=0.113      P=0.033 *   |P=0.490N     P=0.104      P=0.410N     P=0.414      | 
|ORDER RESTRICTED   |     P=0.020 *    (e)          (e)          (e)         |P=0.426N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     50/50 (100%) 47/50 (94%)  47/50 (94%)  49/50 (98%) |44/50 (88%)  39/50 (78%)  40/50 (80%)  40/50 (80%)  | 
|POLY-3 RATE (b)    |     50/50.00     47/47.47     47/47.44     49/49.48    |44/48.74     39/49.07     40/47.96     40/47.30     | 
|POLY-3 PERCENT (g) |     100.0%       99.0%        99.1%        99.0%       |90.3%        79.5%        83.4%        84.6%        | 
|TERMINAL (d)       |     32/32 (100%) 28/28 (100%) 25/25 (100%) 19/19 (100%)|31/35 (89%)  26/34 (77%)  22/26 (85%)  28/32 (88%)  | 
|FIRST INCIDENCE    |     468          471          539          498         |370          455          513          398          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.005 **   P=0.365      P=0.215      P=0.010 *   |P=0.447      P=0.300N     P=0.212      P=0.519N     | 
|POLY 3             |     P=0.563N     P=0.968N     P=0.901N     P=0.862N    |P=0.380N     P=0.109N     P=0.233N     P=0.288N     | 
|POLY 1.5           |     P=0.525N     P=0.387N     P=0.595N     P=0.672N    |P=0.330N     P=0.124N     P=0.215N     P=0.255N     | 
|POLY 6             |     P=0.876N     P=1.000N     P=1.000N     P=1.000N    |P=0.441N     P=0.094N     P=0.270N     P=0.327N     | 
|LOGISTIC REGRESSION|     P=0.153N     (e)          P=0.343N     P=0.442N    |P=0.303N     P=0.146N     P=0.238N     P=0.259N     | 
|COCH-ARM / FISHERS |     P=0.526N     P=0.121N     P=0.121N     P=0.500N    |P=0.259N     P=0.143N     P=0.207N     P=0.207N     | 
|ORDER RESTRICTED   |     P=0.265N     (e)          (e)          (e)         |P=0.217N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/11/04                           EXPERIMENT: 97006 TEST: 01                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                  METHYL ISOBUTYL KETONE    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     31/50 (62%)  35/50 (70%)  34/50 (68%)  41/50 (82%) |22/50 (44%)  27/50 (54%)  22/50 (44%)  25/50 (50%)  | 
|POLY-3 RATE (b)    |     31/48.63     35/47.02     34/48.26     41/48.61    |22/47.31     27/48.61     22/45.28     25/47.45     | 
|POLY-3 PERCENT (g) |     63.7%        74.4%        70.5%        84.4%       |46.5%        55.5%        48.6%        52.7%        | 
|TERMINAL (d)       |     17/32 (53%)  19/28 (68%)  14/25 (56%)  14/19 (74%) |15/35 (43%)  15/34 (44%)  11/26 (42%)  14/32 (44%)  | 
|FIRST INCIDENCE    |     468          338          205          544         |454          356          489          364          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.141      P=0.143      P=0.002 **  |P=0.288      P=0.228      P=0.238      P=0.260      | 
|POLY 3             |     P=0.018 *    P=0.177      P=0.312      P=0.015 *   |P=0.400      P=0.247      P=0.503      P=0.345      | 
|POLY 1.5           |     P=0.019 *    P=0.207      P=0.306      P=0.017 *   |P=0.411      P=0.233      P=0.543      P=0.345      | 
|POLY 6             |     P=0.016 *    P=0.148      P=0.311      P=0.012 *   |P=0.385      P=0.268      P=0.440      P=0.346      | 
|LOGISTIC REGRESSION|     P=0.022 *    P=0.266      P=0.365      P=0.031 *   |P=0.452      P=0.215      P=0.577      P=0.367      | 
|COCH-ARM / FISHERS |     P=0.022 *    P=0.263      P=0.338      P=0.022 *   |P=0.424      P=0.212      P=0.580N     P=0.344      | 
|ORDER RESTRICTED   |     P=0.011 *    (e)          (e)          (e)         |P=0.429      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     CONTROL      450 PPM      900 PPM      1800 PPM    |CONTROL      450 PPM      900 PPM      1800 PPM     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     50/50 (100%) 48/50 (96%)  49/50 (98%)  50/50 (100%)|46/50 (92%)  46/50 (92%)  49/50 (98%)  47/50 (94%)  | 
|POLY-3 RATE (b)    |     50/50.00     48/48.37     49/49.00     50/50.00    |46/49.50     46/50.00     49/50.00     47/50.00     | 
|POLY-3 PERCENT (g) |     100.0%       99.2%        100.0%       100.0%      |92.9%        92.0%        98.0%        94.0%        | 
|TERMINAL (d)       |     32/32 (100%) 28/28 (100%) 25/25 (100%) 19/19 (100%)|32/35 (91%)  30/34 (88%)  25/26 (96%)  29/32 (91%)  | 
|FIRST INCIDENCE    |     468          338          205          498         |370          356          489          364          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.004 **   P=0.307      P=0.140      (e)         |P=0.186      P=0.506      P=0.023 *    P=0.282      | 
|POLY 3             |     P=0.972      P=0.992N     P=1.000N     (e)         |P=0.405      P=0.581N     P=0.226      P=0.576      | 
|POLY 1.5           |     P=0.663      P=0.587N     P=1.000N     (e)         |P=0.379      P=0.608N     P=0.204      P=0.544      | 
|POLY 6             |     P=1.000      P=1.000N     P=1.000N     (e)         |P=0.438      P=0.547N     P=0.259      P=0.615      | 
|LOGISTIC REGRESSION|     P=0.432      P=0.653N     (e)          (e)         |P=0.373      P=0.641N     P=0.188      P=0.517      | 
|COCH-ARM / FISHERS |     P=0.461      P=0.247N     P=0.500N     (e)         |P=0.344      P=0.643N     P=0.181      P=0.500      | 
|ORDER RESTRICTED   |     P=0.245      (e)          (e)          (e)         |P=0.356      (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).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.