National Toxicology Program

National Toxicology Program
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TDMS Study 93005-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/18/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 14:24:19       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/18/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 14:24:19       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Islets, Pancreatic                                                                 
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/18/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 14:24:19       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     MALACHITE GREEN                                                                              
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Adenoma                                                                                      
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Skin                                   Sarcoma                                                                                      
Uterus                                 Polyp Stromal                                                                                
                                       Sarcoma Stromal or Polyp Stromal                                                             
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                      MALACHITE GREEN      
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/48 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/40.06                  0/38.24                  0/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  5.0%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/29 (7%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.138N                 P=0.290N                 P=0.216N                 P=0.271N        | 
|POLY 3             |                  P=0.125N                 P=0.247N                 P=0.220N                 P=0.254N        | 
|POLY 1.5           |                  P=0.130N                 P=0.242N                 P=0.226N                 P=0.249N        | 
|POLY 6             |                  P=0.118N                 P=0.255N                 P=0.213N                 P=0.259N        | 
|LOGISTIC REGRESSION|                  P=0.138N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.139N                 P=0.247N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.035N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/48 (15%)               5/48 (10%)               8/47 (17%)               8/47 (17%)      | 
|POLY-3 RATE (b)    |                  7/40.76                  5/38.26                  8/42.57                  8/37.97         | 
|POLY-3 PERCENT (g) |                  17.2%                    13.1%                    18.8%                    21.1%           | 
|TERMINAL (d)       |                  5/29 (17%)               4/23 (17%)               6/31 (19%)               4/25 (16%)      | 
|FIRST INCIDENCE    |                  533                      722                      692                      570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.275                  P=0.527N                 P=0.561                  P=0.394         | 
|POLY 3             |                  P=0.282                  P=0.423N                 P=0.537                  P=0.439         | 
|POLY 1.5           |                  P=0.276                  P=0.402N                 P=0.516                  P=0.447         | 
|POLY 6             |                  P=0.297                  P=0.455N                 P=0.558                  P=0.438         | 
|LOGISTIC REGRESSION|                  P=0.261                  P=0.437N                 P=0.562                  P=0.440         | 
|COCH-ARM / FISHERS |                  P=0.293                  P=0.379N                 P=0.482                  P=0.482         | 
|ORDER RESTRICTED   |                  P=0.394                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               2/48 (4%)                6/47 (13%)               5/47 (11%)      | 
|POLY-3 RATE (b)    |                  5/41.66                  2/38.24                  6/43.74                  5/38.71         | 
|POLY-3 PERCENT (g) |                  12.0%                    5.2%                     13.7%                    12.9%           | 
|TERMINAL (d)       |                  3/29 (10%)               2/23 (9%)                4/31 (13%)               1/25 (4%)       | 
|FIRST INCIDENCE    |                  401                      728 (T)                  484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.324                  P=0.288N                 P=0.534                  P=0.560         | 
|POLY 3             |                  P=0.337                  P=0.251N                 P=0.534                  P=0.584         | 
|POLY 1.5           |                  P=0.330                  P=0.236N                 P=0.514                  P=0.591         | 
|POLY 6             |                  P=0.349                  P=0.271N                 P=0.556                  P=0.579         | 
|LOGISTIC REGRESSION|                  P=0.439                  P=0.201N                 P=0.287                  P=0.513N        | 
|COCH-ARM / FISHERS |                  P=0.337                  P=0.218N                 P=0.485                  P=0.616         | 
|ORDER RESTRICTED   |                  P=0.408                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/48 (25%)              7/48 (15%)               14/47 (30%)              12/47 (26%)     | 
|POLY-3 RATE (b)    |                  12/42.37                 7/38.26                  14/43.93                 12/39.78        | 
|POLY-3 PERCENT (g) |                  28.3%                    18.3%                    31.9%                    30.2%           | 
|TERMINAL (d)       |                  8/29 (28%)               6/23 (26%)               10/31 (32%)              5/25 (20%)      | 
|FIRST INCIDENCE    |                  401                      722                      484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.259                  P=0.285N                 P=0.485                  P=0.460         | 
|POLY 3             |                  P=0.287                  P=0.211N                 P=0.451                  P=0.524         | 
|POLY 1.5           |                  P=0.270                  P=0.184N                 P=0.424                  P=0.530         | 
|POLY 6             |                  P=0.317                  P=0.250N                 P=0.481                  P=0.526         | 
|LOGISTIC REGRESSION|                  P=0.274                  P=0.165N                 P=0.325                  P=0.576N        | 
|COCH-ARM / FISHERS |                  P=0.277                  P=0.153N                 P=0.385                  P=0.570         | 
|ORDER RESTRICTED   |                  P=0.352                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                1/48 (2%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.24                  1/43.37                  1/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     2.3%                     2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/23 (9%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.534                  P=0.188                  P=0.520                  P=0.470         | 
|POLY 3             |                  P=0.515                  P=0.226                  P=0.516                  P=0.485         | 
|POLY 1.5           |                  P=0.522                  P=0.232                  P=0.510                  P=0.489         | 
|POLY 6             |                  P=0.505                  P=0.218                  P=0.522                  P=0.480         | 
|LOGISTIC REGRESSION|                  (e)                      P=0.188                  P=0.520                  P=0.470         | 
|COCH-ARM / FISHERS |                  P=0.544                  P=0.247                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.281                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                1/48 (2%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.24                  1/43.37                  1/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     2.3%                     2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/23 (9%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.534                  P=0.188                  P=0.520                  P=0.470         | 
|POLY 3             |                  P=0.515                  P=0.226                  P=0.516                  P=0.485         | 
|POLY 1.5           |                  P=0.522                  P=0.232                  P=0.510                  P=0.489         | 
|POLY 6             |                  P=0.505                  P=0.218                  P=0.522                  P=0.480         | 
|LOGISTIC REGRESSION|                  (e)                      P=0.188                  P=0.520                  P=0.470         | 
|COCH-ARM / FISHERS |                  P=0.544                  P=0.247                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.281                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                3/48 (6%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  1/38.24                  3/43.66                  4/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     6.9%                     10.8%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                2/32 (6%)                4/25 (16%)      | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  652                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.058                  P=0.710                  P=0.355                  P=0.134         | 
|POLY 3             |                  P=0.059                  P=0.751                  P=0.336                  P=0.155         | 
|POLY 1.5           |                  P=0.061                  P=0.755                  P=0.324                  P=0.162         | 
|POLY 6             |                  P=0.058                  P=0.743                  P=0.350                  P=0.147         | 
|LOGISTIC REGRESSION|                  P=0.053                  P=0.710                  P=0.337                  P=0.134         | 
|COCH-ARM / FISHERS |                  P=0.068                  P=0.753N                 P=0.308                  P=0.181         | 
|ORDER RESTRICTED   |                  P=0.093                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                3/48 (6%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  1/38.24                  3/43.66                  4/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     6.9%                     10.8%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                2/32 (6%)                4/25 (16%)      | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  652                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.058                  P=0.710                  P=0.355                  P=0.134         | 
|POLY 3             |                  P=0.059                  P=0.751                  P=0.336                  P=0.155         | 
|POLY 1.5           |                  P=0.061                  P=0.755                  P=0.324                  P=0.162         | 
|POLY 6             |                  P=0.058                  P=0.743                  P=0.350                  P=0.147         | 
|LOGISTIC REGRESSION|                  P=0.053                  P=0.710                  P=0.337                  P=0.134         | 
|COCH-ARM / FISHERS |                  P=0.068                  P=0.753N                 P=0.308                  P=0.181         | 
|ORDER RESTRICTED   |                  P=0.093                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                3/48 (6%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  1/38.24                  3/43.66                  4/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     6.9%                     10.8%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                2/32 (6%)                4/25 (16%)      | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  652                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.058                  P=0.710                  P=0.355                  P=0.134         | 
|POLY 3             |                  P=0.059                  P=0.751                  P=0.336                  P=0.155         | 
|POLY 1.5           |                  P=0.061                  P=0.755                  P=0.324                  P=0.162         | 
|POLY 6             |                  P=0.058                  P=0.743                  P=0.350                  P=0.147         | 
|LOGISTIC REGRESSION|                  P=0.053                  P=0.710                  P=0.337                  P=0.134         | 
|COCH-ARM / FISHERS |                  P=0.068                  P=0.753N                 P=0.308                  P=0.181         | 
|ORDER RESTRICTED   |                  P=0.093                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                2/48 (4%)                1/48 (2%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  2/40.15                  2/38.40                  1/43.37                  5/38.50         | 
|POLY-3 PERCENT (g) |                  5.0%                     5.2%                     2.3%                     13.0%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                1/32 (3%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  704                      686                      728 (T)                  508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.100                  P=0.632                  P=0.470N                 P=0.174         | 
|POLY 3             |                  P=0.113                  P=0.679                  P=0.473N                 P=0.197         | 
|POLY 1.5           |                  P=0.112                  P=0.686                  P=0.483N                 P=0.201         | 
|POLY 6             |                  P=0.116                  P=0.667                  P=0.463N                 P=0.194         | 
|LOGISTIC REGRESSION|                  P=0.108                  P=0.664                  P=0.457N                 P=0.211         | 
|COCH-ARM / FISHERS |                  P=0.114                  P=0.692N                 P=0.500N                 P=0.218         | 
|ORDER RESTRICTED   |                  P=0.079                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/48 (31%)              13/48 (27%)              12/48 (25%)              9/48 (19%)      | 
|POLY-3 RATE (b)    |                  15/42.20                 13/40.47                 12/44.52                 9/38.15         | 
|POLY-3 PERCENT (g) |                  35.5%                    32.1%                    27.0%                    23.6%           | 
|TERMINAL (d)       |                  11/29 (38%)              7/23 (30%)               7/32 (22%)               5/25 (20%)      | 
|FIRST INCIDENCE    |                  401                      494                      626                      620             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.132N                 P=0.551                  P=0.239N                 P=0.225N        | 
|POLY 3             |                  P=0.127N                 P=0.461N                 P=0.263N                 P=0.175N        | 
|POLY 1.5           |                  P=0.122N                 P=0.439N                 P=0.289N                 P=0.158N        | 
|POLY 6             |                  P=0.126N                 P=0.492N                 P=0.230N                 P=0.190N        | 
|LOGISTIC REGRESSION|                  P=0.109N                 P=0.422N                 P=0.317N                 P=0.149N        | 
|COCH-ARM / FISHERS |                  P=0.097N                 P=0.411N                 P=0.325N                 P=0.119N        | 
|ORDER RESTRICTED   |                  P=0.191N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  16/48 (33%)              14/48 (29%)              12/48 (25%)              14/48 (29%)     | 
|POLY-3 RATE (b)    |                  16/42.20                 14/40.63                 12/44.52                 14/39.47        | 
|POLY-3 PERCENT (g) |                  37.9%                    34.5%                    27.0%                    35.5%           | 
|TERMINAL (d)       |                  12/29 (41%)              7/23 (30%)               7/32 (22%)               7/25 (28%)      | 
|FIRST INCIDENCE    |                  401                      494                      626                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.441N                 P=0.538                  P=0.178N                 P=0.582         | 
|POLY 3             |                  P=0.415N                 P=0.460N                 P=0.193N                 P=0.500N        | 
|POLY 1.5           |                  P=0.417N                 P=0.440N                 P=0.217N                 P=0.482N        | 
|POLY 6             |                  P=0.399N                 P=0.487N                 P=0.164N                 P=0.507N        | 
|LOGISTIC REGRESSION|                  P=0.407N                 P=0.429N                 P=0.236N                 P=0.467N        | 
|COCH-ARM / FISHERS |                  P=0.378N                 P=0.413N                 P=0.250N                 P=0.413N        | 
|ORDER RESTRICTED   |                  P=0.401N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  26/48 (54%)              36/47 (77%)              32/46 (70%)              29/45 (64%)     | 
|POLY-3 RATE (b)    |                  26/42.81                 36/43.56                 32/44.71                 29/38.05        | 
|POLY-3 PERCENT (g) |                  60.7%                    82.7%                    71.6%                    76.2%           | 
|TERMINAL (d)       |                  16/29 (55%)              21/23 (91%)              22/32 (69%)              21/25 (84%)     | 
|FIRST INCIDENCE    |                  552                      485                      603                      570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.469                  P=0.008 **               P=0.383                  P=0.140         | 
|POLY 3             |                  P=0.233                  P=0.014 *                P=0.193                  P=0.092         | 
|POLY 1.5           |                  P=0.267                  P=0.016 *                P=0.146                  P=0.121         | 
|POLY 6             |                  P=0.205                  P=0.011 *                P=0.252                  P=0.067         | 
|LOGISTIC REGRESSION|                  P=0.335                  P=0.012 *                P=0.187                  P=0.116         | 
|COCH-ARM / FISHERS |                  P=0.403                  P=0.018 *                P=0.093                  P=0.213         | 
|ORDER RESTRICTED   |                  P=0.069                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  26/48 (54%)              36/47 (77%)              32/46 (70%)              30/45 (67%)     | 
|POLY-3 RATE (b)    |                  26/42.81                 36/43.56                 32/44.71                 30/38.22        | 
|POLY-3 PERCENT (g) |                  60.7%                    82.7%                    71.6%                    78.5%           | 
|TERMINAL (d)       |                  16/29 (55%)              21/23 (91%)              22/32 (69%)              21/25 (84%)     | 
|FIRST INCIDENCE    |                  552                      485                      603                      570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.393                  P=0.008 **               P=0.383                  P=0.105         | 
|POLY 3             |                  P=0.162                  P=0.014 *                P=0.193                  P=0.056         | 
|POLY 1.5           |                  P=0.190                  P=0.016 *                P=0.146                  P=0.077         | 
|POLY 6             |                  P=0.145                  P=0.011 *                P=0.252                  P=0.041 *       | 
|LOGISTIC REGRESSION|                  P=0.246                  P=0.012 *                P=0.187                  P=0.074         | 
|COCH-ARM / FISHERS |                  P=0.313                  P=0.018 *                P=0.093                  P=0.154         | 
|ORDER RESTRICTED   |                  P=0.043 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 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)        |                  1/48 (2%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  0/38.24                  2/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/23 (0%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  ---                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.510N                 P=0.546N                 P=0.535                  P=0.530N        | 
|POLY 3             |                  P=0.515N                 P=0.509N                 P=0.528                  P=0.515N        | 
|POLY 1.5           |                  P=0.513N                 P=0.505N                 P=0.517                  P=0.511N        | 
|POLY 6             |                  P=0.516N                 P=0.516N                 P=0.539                  P=0.520N        | 
|LOGISTIC REGRESSION|                  P=0.510N                 (e)                      P=0.535                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.500N                 P=0.500N                 P=0.500                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.339N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                1/48 (2%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  1/38.24                  0/43.37                  2/37.80         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/23 (4%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  ---                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.148                  P=0.454                  (e)                      P=0.223         | 
|POLY 3             |                  P=0.151                  P=0.491                  (e)                      P=0.224         | 
|POLY 1.5           |                  P=0.151                  P=0.495                  (e)                      P=0.227         | 
|POLY 6             |                  P=0.151                  P=0.484                  (e)                      P=0.221         | 
|LOGISTIC REGRESSION|                  P=0.154                  P=0.454                  (e)                      P=0.245         | 
|COCH-ARM / FISHERS |                  P=0.155                  P=0.500                  (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.066                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  0/43.37                  2/37.80         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.040 *                (e)                      (e)                      P=0.223         | 
|POLY 3             |                  P=0.043 *                (e)                      (e)                      P=0.224         | 
|POLY 1.5           |                  P=0.042 *                (e)                      (e)                      P=0.227         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.221         | 
|LOGISTIC REGRESSION|                  P=0.050                  (e)                      (e)                      P=0.245         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.025 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  2/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.555                  (e)                      P=0.260                  (e)             | 
|POLY 3             |                  P=0.516                  (e)                      P=0.255                  (e)             | 
|POLY 1.5           |                  P=0.528                  (e)                      P=0.248                  (e)             | 
|POLY 6             |                  P=0.502                  (e)                      P=0.262                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.260                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.562                  (e)                      P=0.247                  (e)             | 
|ORDER RESTRICTED   |                  P=0.264                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  2/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.555                  (e)                      P=0.260                  (e)             | 
|POLY 3             |                  P=0.516                  (e)                      P=0.255                  (e)             | 
|POLY 1.5           |                  P=0.528                  (e)                      P=0.248                  (e)             | 
|POLY 6             |                  P=0.502                  (e)                      P=0.262                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.260                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.562                  (e)                      P=0.247                  (e)             | 
|ORDER RESTRICTED   |                  P=0.264                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/46 (9%)                5/48 (10%)               3/47 (6%)                3/46 (7%)       | 
|POLY-3 RATE (b)    |                  4/38.45                  5/38.83                  3/42.41                  3/35.34         | 
|POLY-3 PERCENT (g) |                  10.4%                    12.9%                    7.1%                     8.5%            | 
|TERMINAL (d)       |                  3/29 (10%)               4/23 (17%)               2/31 (7%)                3/24 (13%)      | 
|FIRST INCIDENCE    |                  711                      539                      719                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.359N                 P=0.380                  P=0.460N                 P=0.605N        | 
|POLY 3             |                  P=0.348N                 P=0.506                  P=0.446N                 P=0.546N        | 
|POLY 1.5           |                  P=0.345N                 P=0.517                  P=0.462N                 P=0.532N        | 
|POLY 6             |                  P=0.350N                 P=0.487                  P=0.432N                 P=0.564N        | 
|LOGISTIC REGRESSION|                  P=0.355N                 P=0.481                  P=0.434N                 P=0.601N        | 
|COCH-ARM / FISHERS |                  P=0.327N                 P=0.527                  P=0.488N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.458N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/46 (7%)                1/48 (2%)                2/47 (4%)                1/46 (2%)       | 
|POLY-3 RATE (b)    |                  3/38.68                  1/38.83                  2/42.41                  1/35.34         | 
|POLY-3 PERCENT (g) |                  7.8%                     2.6%                     4.7%                     2.8%            | 
|TERMINAL (d)       |                  2/29 (7%)                0/23 (0%)                1/31 (3%)                1/24 (4%)       | 
|FIRST INCIDENCE    |                  647                      540                      719                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.326N                 P=0.355N                 P=0.454N                 P=0.366N        | 
|POLY 3             |                  P=0.323N                 P=0.303N                 P=0.458N                 P=0.337N        | 
|POLY 1.5           |                  P=0.322N                 P=0.296N                 P=0.470N                 P=0.327N        | 
|POLY 6             |                  P=0.322N                 P=0.315N                 P=0.448N                 P=0.351N        | 
|LOGISTIC REGRESSION|                  P=0.321N                 P=0.285N                 P=0.449N                 P=0.343N        | 
|COCH-ARM / FISHERS |                  P=0.312N                 P=0.292N                 P=0.490N                 P=0.308N        | 
|ORDER RESTRICTED   |                  P=0.255N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/46 (15%)               6/48 (13%)               4/47 (9%)                4/46 (9%)       | 
|POLY-3 RATE (b)    |                  7/38.75                  6/39.42                  4/42.41                  4/35.34         | 
|POLY-3 PERCENT (g) |                  18.1%                    15.2%                    9.4%                     11.3%           | 
|TERMINAL (d)       |                  5/29 (17%)               4/23 (17%)               3/31 (10%)               4/24 (17%)      | 
|FIRST INCIDENCE    |                  647                      539                      719                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.213N                 P=0.601                  P=0.218N                 P=0.373N        | 
|POLY 3             |                  P=0.207N                 P=0.486N                 P=0.209N                 P=0.313N        | 
|POLY 1.5           |                  P=0.205N                 P=0.475N                 P=0.223N                 P=0.296N        | 
|POLY 6             |                  P=0.210N                 P=0.509N                 P=0.198N                 P=0.337N        | 
|LOGISTIC REGRESSION|                  P=0.207N                 P=0.496N                 P=0.188N                 P=0.343N        | 
|COCH-ARM / FISHERS |                  P=0.188N                 P=0.467N                 P=0.249N                 P=0.261N        | 
|ORDER RESTRICTED   |                  P=0.271N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                0/48 (0%)                2/47 (4%)                1/46 (2%)       | 
|POLY-3 RATE (b)    |                  0/38.38                  0/38.24                  2/42.37                  1/35.34         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.7%                     2.8%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                2/31 (7%)                1/24 (4%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.201                  (e)                      P=0.253                  P=0.462         | 
|POLY 3             |                  P=0.191                  (e)                      P=0.259                  P=0.484         | 
|POLY 1.5           |                  P=0.198                  (e)                      P=0.253                  P=0.488         | 
|POLY 6             |                  P=0.184                  (e)                      P=0.266                  P=0.477         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.253                  P=0.462         | 
|COCH-ARM / FISHERS |                  P=0.219                  (e)                      P=0.253                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.188                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                0/48 (0%)                3/47 (6%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  0/38.38                  0/38.24                  3/42.37                  2/35.34         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     7.1%                     5.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                3/31 (10%)               2/24 (8%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.067                  (e)                      P=0.132                  P=0.197         | 
|POLY 3             |                  P=0.064                  (e)                      P=0.137                  P=0.218         | 
|POLY 1.5           |                  P=0.068                  (e)                      P=0.131                  P=0.224         | 
|POLY 6             |                  P=0.061                  (e)                      P=0.142                  P=0.212         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.132                  P=0.197         | 
|COCH-ARM / FISHERS |                  P=0.080                  (e)                      P=0.125                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.095                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  14/48 (29%)              7/48 (15%)               5/48 (10%)               16/48 (33%)     | 
|POLY-3 RATE (b)    |                  14/41.62                 7/39.90                  5/44.06                  16/39.03        | 
|POLY-3 PERCENT (g) |                  33.6%                    17.5%                    11.4%                    41.0%           | 
|TERMINAL (d)       |                  10/29 (35%)              3/23 (13%)               3/32 (9%)                11/25 (44%)     | 
|FIRST INCIDENCE    |                  529                      596                      603                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.169                  P=0.165N                 P=0.013N*                P=0.263         | 
|POLY 3             |                  P=0.172                  P=0.076N                 P=0.011N*                P=0.323         | 
|POLY 1.5           |                  P=0.171                  P=0.072N                 P=0.013N*                P=0.347         | 
|POLY 6             |                  P=0.174                  P=0.083N                 P=0.009N**               P=0.299         | 
|LOGISTIC REGRESSION|                  P=0.167                  P=0.075N                 P=0.017N*                P=0.326         | 
|COCH-ARM / FISHERS |                  P=0.190                  P=0.069N                 P=0.019N*                P=0.413         | 
|ORDER RESTRICTED   |                  P=0.021 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                1/48 (2%)                1/48 (2%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/40.53                  1/38.24                  1/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  4.9%                     2.6%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  589                      728 (T)                  728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.163N                 P=0.559N                 P=0.464N                 P=0.265N        | 
|POLY 3             |                  P=0.163N                 P=0.520N                 P=0.476N                 P=0.256N        | 
|POLY 1.5           |                  P=0.164N                 P=0.511N                 P=0.485N                 P=0.250N        | 
|POLY 6             |                  P=0.162N                 P=0.535N                 P=0.468N                 P=0.264N        | 
|LOGISTIC REGRESSION|                  P=0.163N                 P=0.507N                 P=0.510N                 P=0.234N        | 
|COCH-ARM / FISHERS |                  P=0.161N                 P=0.500N                 P=0.500N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.134N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  16/48 (33%)              8/48 (17%)               6/48 (13%)               16/48 (33%)     | 
|POLY-3 RATE (b)    |                  16/42.09                 8/39.90                  6/44.06                  16/39.03        | 
|POLY-3 PERCENT (g) |                  38.0%                    20.1%                    13.6%                    41.0%           | 
|TERMINAL (d)       |                  11/29 (38%)              4/23 (17%)               4/32 (13%)               11/25 (44%)     | 
|FIRST INCIDENCE    |                  529                      596                      603                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.308                  P=0.137N                 P=0.009N**               P=0.411         | 
|POLY 3             |                  P=0.319                  P=0.057N                 P=0.007N**               P=0.481         | 
|POLY 1.5           |                  P=0.319                  P=0.052N                 P=0.009N**               P=0.512         | 
|POLY 6             |                  P=0.322                  P=0.066N                 P=0.006N**               P=0.446         | 
|LOGISTIC REGRESSION|                  P=0.309                  P=0.054N                 P=0.012N*                P=0.500         | 
|COCH-ARM / FISHERS |                  P=0.342                  P=0.049N*                P=0.014N*                P=0.586N        | 
|ORDER RESTRICTED   |                  P=0.055                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                0/48 (0%)                1/48 (2%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  1/40.40                  0/38.24                  1/43.66                  2/38.24         | 
|POLY-3 PERCENT (g) |                  2.5%                     0.0%                     2.3%                     5.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  631                      ---                      652                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.217                  P=0.529N                 P=0.719N                 P=0.484         | 
|POLY 3             |                  P=0.218                  P=0.511N                 P=0.743N                 P=0.481         | 
|POLY 1.5           |                  P=0.216                  P=0.506N                 P=0.750N                 P=0.485         | 
|POLY 6             |                  P=0.222                  P=0.519N                 P=0.736N                 P=0.476         | 
|LOGISTIC REGRESSION|                  P=0.288                  P=0.492N                 P=0.718                  P=0.576         | 
|COCH-ARM / FISHERS |                  P=0.220                  P=0.500N                 P=0.753N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.210                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  19/48 (40%)              17/48 (35%)              10/48 (21%)              1/48 (2%)       | 
|POLY-3 RATE (b)    |                  19/43.47                 17/42.53                 10/44.53                 1/37.76         | 
|POLY-3 PERCENT (g) |                  43.7%                    40.0%                    22.5%                    2.7%            | 
|TERMINAL (d)       |                  9/29 (31%)               4/23 (17%)               4/32 (13%)               0/25 (0%)       | 
|FIRST INCIDENCE    |                  526                      443                      619                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001N**               P=0.533                  P=0.030N*                P<0.001N**      | 
|POLY 3             |                  P<0.001N**               P=0.447N                 P=0.026N*                P<0.001N**      | 
|POLY 1.5           |                  P<0.001N**               P=0.431N                 P=0.029N*                P<0.001N**      | 
|POLY 6             |                  P<0.001N**               P=0.470N                 P=0.025N*                P<0.001N**      | 
|LOGISTIC REGRESSION|                  P<0.001N**               P=0.402N                 P=0.042N*                P<0.001N**      | 
|COCH-ARM / FISHERS |                  P<0.001N**               P=0.417N                 P=0.037N*                P<0.001N**      | 
|ORDER RESTRICTED   |                  P<0.001N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  41/48 (85%)              42/48 (88%)              40/48 (83%)              35/48 (73%)     | 
|POLY-3 RATE (b)    |                  41/45.78                 42/45.17                 40/46.30                 35/41.98        | 
|POLY-3 PERCENT (g) |                  89.6%                    93.0%                    86.4%                    83.4%           | 
|TERMINAL (d)       |                  26/29 (90%)              23/23 (100%)             28/32 (88%)              21/25 (84%)     | 
|FIRST INCIDENCE    |                  401                      485                      603                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.195N                 P=0.120                  P=0.226N                 P=0.500N        | 
|POLY 3             |                  P=0.114N                 P=0.407                  P=0.439N                 P=0.279N        | 
|POLY 1.5           |                  P=0.091N                 P=0.455                  P=0.464N                 P=0.215N        | 
|POLY 6             |                  P=0.127N                 P=0.331                  P=0.411N                 P=0.342N        | 
|LOGISTIC REGRESSION|                  P=0.075N                 P=0.441                  P=0.312N                 P=0.205N        | 
|COCH-ARM / FISHERS |                  P=0.038N*                P=0.500                  P=0.500N                 P=0.104N        | 
|ORDER RESTRICTED   |                  P=0.166N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93005 TEST: 03                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                      MALACHITE GREEN       
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  29/48 (60%)              24/48 (50%)              21/48 (44%)              23/48 (48%)     | 
|POLY-3 RATE (b)    |                  29/46.60                 24/43.53                 21/46.18                 23/43.75        | 
|POLY-3 PERCENT (g) |                  62.2%                    55.1%                    45.5%                    52.6%           | 
|TERMINAL (d)       |                  13/29 (45%)              9/23 (39%)               12/32 (38%)              9/25 (36%)      | 
|FIRST INCIDENCE    |                  401                      443                      484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.265N                 P=0.487N                 P=0.065N                 P=0.378N        | 
|POLY 3             |                  P=0.186N                 P=0.317N                 P=0.076N                 P=0.235N        | 
|POLY 1.5           |                  P=0.183N                 P=0.268N                 P=0.074N                 P=0.211N        | 
|POLY 6             |                  P=0.191N                 P=0.378N                 P=0.082N                 P=0.262N        | 
|LOGISTIC REGRESSION|                  P=0.121N                 P=0.173N                 P=0.147N                 P=0.109N        | 
|COCH-ARM / FISHERS |                  P=0.157N                 P=0.206N                 P=0.076N                 P=0.153N        | 
|ORDER RESTRICTED   |                  P=0.152N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  47/48 (98%)              48/48 (100%)             46/48 (96%)              42/48 (88%)     | 
|POLY-3 RATE (b)    |                  47/48.00                 48/48.00                 46/48.00                 42/44.74        | 
|POLY-3 PERCENT (g) |                  97.9%                    100.0%                   95.8%                    93.9%           | 
|TERMINAL (d)       |                  28/29 (97%)              23/23 (100%)             30/32 (94%)              24/25 (96%)     | 
|FIRST INCIDENCE    |                  401                      443                      484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.282N                 P=0.129                  P=0.216N                 P=0.526         | 
|POLY 3             |                  P=0.084N                 P=0.500                  P=0.500N                 P=0.306N        | 
|POLY 1.5           |                  P=0.034N*                P=0.500                  P=0.500N                 P=0.187N        | 
|POLY 6             |                  P=0.172N                 P=0.500                  P=0.500N                 P=0.463N        | 
|LOGISTIC REGRESSION|                  P=0.013N*                (e)                      (e)                      P=0.123N        | 
|COCH-ARM / FISHERS |                  P=0.004N**               P=0.500                  P=0.500N                 P=0.056N        | 
|ORDER RESTRICTED   |                  P=0.100N                 (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.