National Toxicology Program

National Toxicology Program
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TDMS Study 93029-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:04:52       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
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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                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:04:52       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
Mice(C57BL/6NXC3H/HEN MTN-NCTR)                                                                                                     
-----------------------------                                                                                                       
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.                                                                                      
                                                 ---------------                                                                    
                                                 Bone Marrow                                                                        
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pituitary Gland                                                                    
                                                 Spleen                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:04:52       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  LEUKOMALACHITE GREEN                                                                            
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Liver                                  Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Lung                                   Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Ovary                                  Teratoma Benign                                                                              
Spleen                                 Hemangiosarcoma                                                                              
Uterus                                 Sarcoma Stromal                                                                              
===============================================================                                                                     
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)        -                   LEUKOMALACHITE GREEN           
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                2/48 (4%)                4/48 (8%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  2/43.52                  2/46.24                  4/44.56                  5/45.09         | 
|POLY-3 PERCENT (g) |                  4.6%                     4.3%                     9.0%                     11.1%           | 
|TERMINAL (d)       |                  2/37 (5%)                2/41 (5%)                3/39 (8%)                5/39 (13%)      | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  675                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.113                  P=0.658N                 P=0.358                  P=0.237         | 
|POLY 3             |                  P=0.114                  P=0.672N                 P=0.348                  P=0.231         | 
|POLY 1.5           |                  P=0.114                  P=0.676N                 P=0.347                  P=0.230         | 
|POLY 6             |                  P=0.113                  P=0.668N                 P=0.350                  P=0.232         | 
|LOGISTIC REGRESSION|                  P=0.113                  P=0.658N                 P=0.345                  P=0.237         | 
|COCH-ARM / FISHERS |                  P=0.110                  P=0.692N                 P=0.339                  P=0.218         | 
|ORDER RESTRICTED   |                  P=0.181                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/48 (6%)                2/48 (4%)                4/48 (8%)                6/48 (13%)      | 
|POLY-3 RATE (b)    |                  3/43.67                  2/46.24                  4/44.56                  6/45.09         | 
|POLY-3 PERCENT (g) |                  6.9%                     4.3%                     9.0%                     13.3%           | 
|TERMINAL (d)       |                  2/37 (5%)                2/41 (5%)                3/39 (8%)                6/39 (15%)      | 
|FIRST INCIDENCE    |                  695                      733 (T)                  675                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.111                  P=0.454N                 P=0.522                  P=0.271         | 
|POLY 3             |                  P=0.107                  P=0.474N                 P=0.511                  P=0.258         | 
|POLY 1.5           |                  P=0.109                  P=0.479N                 P=0.510                  P=0.257         | 
|POLY 6             |                  P=0.106                  P=0.470N                 P=0.512                  P=0.257         | 
|LOGISTIC REGRESSION|                  P=0.109                  P=0.472N                 P=0.509                  P=0.262         | 
|COCH-ARM / FISHERS |                  P=0.106                  P=0.500N                 P=0.500                  P=0.243         | 
|ORDER RESTRICTED   |                  P=0.147                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/47 (6%)                6/48 (13%)               5/47 (11%)               9/47 (19%)      | 
|POLY-3 RATE (b)    |                  3/43.40                  6/46.93                  5/43.97                  9/44.65         | 
|POLY-3 PERCENT (g) |                  6.9%                     12.8%                    11.4%                    20.2%           | 
|TERMINAL (d)       |                  2/37 (5%)                5/41 (12%)               5/39 (13%)               9/39 (23%)      | 
|FIRST INCIDENCE    |                  682                      498                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.058                  P=0.293                  P=0.381                  P=0.073         | 
|POLY 3             |                  P=0.055                  P=0.282                  P=0.363                  P=0.065         | 
|POLY 1.5           |                  P=0.056                  P=0.277                  P=0.364                  P=0.065         | 
|POLY 6             |                  P=0.054                  P=0.286                  P=0.361                  P=0.065         | 
|LOGISTIC REGRESSION|                  P=0.056                  P=0.235                  P=0.365                  P=0.069         | 
|COCH-ARM / FISHERS |                  P=0.053                  P=0.254                  P=0.357                  P=0.060         | 
|ORDER RESTRICTED   |                  P=0.046 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/48 (0%)                1/47 (2%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  0/46.24                  1/43.97                  2/44.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     4.5%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                1/39 (3%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.068                  (e)                      P=0.511                  P=0.250         | 
|POLY 3             |                  P=0.068                  (e)                      P=0.504                  P=0.245         | 
|POLY 1.5           |                  P=0.068                  (e)                      P=0.503                  P=0.244         | 
|POLY 6             |                  P=0.068                  (e)                      P=0.504                  P=0.245         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.511                  P=0.250         | 
|COCH-ARM / FISHERS |                  P=0.067                  (e)                      P=0.500                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.079                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/47 (6%)                6/48 (13%)               6/47 (13%)               11/47 (23%)     | 
|POLY-3 RATE (b)    |                  3/43.40                  6/46.93                  6/43.97                  11/44.65        | 
|POLY-3 PERCENT (g) |                  6.9%                     12.8%                    13.6%                    24.6%           | 
|TERMINAL (d)       |                  2/37 (5%)                5/41 (12%)               6/39 (15%)               11/39 (28%)     | 
|FIRST INCIDENCE    |                  682                      498                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.015 *                P=0.293                  P=0.265                  P=0.027 *       | 
|POLY 3             |                  P=0.013 *                P=0.282                  P=0.248                  P=0.022 *       | 
|POLY 1.5           |                  P=0.014 *                P=0.277                  P=0.249                  P=0.022 *       | 
|POLY 6             |                  P=0.013 *                P=0.286                  P=0.246                  P=0.021 *       | 
|LOGISTIC REGRESSION|                  P=0.014 *                P=0.235                  P=0.250                  P=0.025 *       | 
|COCH-ARM / FISHERS |                  P=0.013 *                P=0.254                  P=0.243                  P=0.020 *       | 
|ORDER RESTRICTED   |                  P=0.012 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/47 (6%)                6/48 (13%)               6/47 (13%)               11/47 (23%)     | 
|POLY-3 RATE (b)    |                  3/43.40                  6/46.93                  6/43.97                  11/44.65        | 
|POLY-3 PERCENT (g) |                  6.9%                     12.8%                    13.6%                    24.6%           | 
|TERMINAL (d)       |                  2/37 (5%)                5/41 (12%)               6/39 (15%)               11/39 (28%)     | 
|FIRST INCIDENCE    |                  682                      498                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.015 *                P=0.293                  P=0.265                  P=0.027 *       | 
|POLY 3             |                  P=0.013 *                P=0.282                  P=0.248                  P=0.022 *       | 
|POLY 1.5           |                  P=0.014 *                P=0.277                  P=0.249                  P=0.022 *       | 
|POLY 6             |                  P=0.013 *                P=0.286                  P=0.246                  P=0.021 *       | 
|LOGISTIC REGRESSION|                  P=0.014 *                P=0.235                  P=0.250                  P=0.025 *       | 
|COCH-ARM / FISHERS |                  P=0.013 *                P=0.254                  P=0.243                  P=0.020 *       | 
|ORDER RESTRICTED   |                  P=0.012 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 4       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                1/48 (2%)                0/47 (0%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  1/43.34                  1/46.41                  0/43.97                  2/46.00         | 
|POLY-3 PERCENT (g) |                  2.3%                     2.2%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  700                      690                      ---                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.379                  P=0.734N                 P=0.490N                 P=0.521         | 
|POLY 3             |                  P=0.375                  P=0.745N                 P=0.497N                 P=0.521         | 
|POLY 1.5           |                  P=0.373                  P=0.747N                 P=0.497N                 P=0.517         | 
|POLY 6             |                  P=0.376                  P=0.744N                 P=0.498N                 P=0.524         | 
|LOGISTIC REGRESSION|                  P=0.268                  P=0.761                  P=0.501N                 P=0.340         | 
|COCH-ARM / FISHERS |                  P=0.365                  P=0.747N                 P=0.500N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.290                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/47 (6%)                1/48 (2%)                2/47 (4%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  3/43.21                  1/46.24                  2/44.66                  1/44.65         | 
|POLY-3 PERCENT (g) |                  6.9%                     2.2%                     4.5%                     2.2%            | 
|TERMINAL (d)       |                  3/37 (8%)                1/41 (2%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  498                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.280N                 P=0.269N                 P=0.477N                 P=0.286N        | 
|POLY 3             |                  P=0.290N                 P=0.281N                 P=0.485N                 P=0.294N        | 
|POLY 1.5           |                  P=0.289N                 P=0.284N                 P=0.488N                 P=0.295N        | 
|POLY 6             |                  P=0.290N                 P=0.279N                 P=0.482N                 P=0.292N        | 
|LOGISTIC REGRESSION|                  P=0.298N                 P=0.269N                 P=0.509N                 P=0.286N        | 
|COCH-ARM / FISHERS |                  P=0.290N                 P=0.301N                 P=0.500N                 P=0.308N        | 
|ORDER RESTRICTED   |                  P=0.206N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 5       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                0/48 (0%)                0/47 (0%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.21                  0/46.24                  0/43.97                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.6%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.119N                 P=0.216N                 P=0.227N                 P=0.227N        | 
|POLY 3             |                  P=0.126N                 P=0.222N                 P=0.233N                 P=0.230N        | 
|POLY 1.5           |                  P=0.125N                 P=0.224N                 P=0.233N                 P=0.230N        | 
|POLY 6             |                  P=0.127N                 P=0.221N                 P=0.233N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.119N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.123N                 P=0.242N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.027N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/47 (11%)               1/48 (2%)                2/47 (4%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  5/43.21                  1/46.24                  2/44.66                  1/44.65         | 
|POLY-3 PERCENT (g) |                  11.6%                    2.2%                     4.5%                     2.2%            | 
|TERMINAL (d)       |                  5/37 (14%)               1/41 (2%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  498                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.095N                 P=0.081N                 P=0.198N                 P=0.091N        | 
|POLY 3             |                  P=0.100N                 P=0.086N                 P=0.203N                 P=0.094N        | 
|POLY 1.5           |                  P=0.100N                 P=0.088N                 P=0.205N                 P=0.094N        | 
|POLY 6             |                  P=0.100N                 P=0.085N                 P=0.200N                 P=0.093N        | 
|LOGISTIC REGRESSION|                  P=0.102N                 P=0.081N                 P=0.217N                 P=0.091N        | 
|COCH-ARM / FISHERS |                  P=0.101N                 P=0.097N                 P=0.217N                 P=0.102N        | 
|ORDER RESTRICTED   |                  P=0.032N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 6       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoacanthoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/48 (0%)                1/48 (2%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.69                  0/46.24                  1/45.03                  0/45.09         | 
|POLY-3 PERCENT (g) |                  4.6%                     0.0%                     2.2%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  688                      ---                      498                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.197N                 P=0.219N                 P=0.489N                 P=0.229N        | 
|POLY 3             |                  P=0.204N                 P=0.225N                 P=0.489N                 P=0.230N        | 
|POLY 1.5           |                  P=0.202N                 P=0.227N                 P=0.491N                 P=0.230N        | 
|POLY 6             |                  P=0.205N                 P=0.223N                 P=0.489N                 P=0.230N        | 
|LOGISTIC REGRESSION|                  P=0.227N                 P=0.233N                 P=0.525N                 P=0.234N        | 
|COCH-ARM / FISHERS |                  P=0.199N                 P=0.247N                 P=0.500N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.070N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                2/48 (4%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  1/43.52                  1/46.24                  2/44.34                  4/45.15         | 
|POLY-3 PERCENT (g) |                  2.3%                     2.2%                     4.5%                     8.9%            | 
|TERMINAL (d)       |                  1/37 (3%)                1/41 (2%)                2/39 (5%)                3/39 (8%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.074                  P=0.739N                 P=0.518                  P=0.202         | 
|POLY 3             |                  P=0.072                  P=0.747N                 P=0.507                  P=0.190         | 
|POLY 1.5           |                  P=0.072                  P=0.750N                 P=0.506                  P=0.189         | 
|POLY 6             |                  P=0.071                  P=0.744N                 P=0.506                  P=0.191         | 
|LOGISTIC REGRESSION|                  P=0.072                  P=0.739N                 P=0.518                  P=0.193         | 
|COCH-ARM / FISHERS |                  P=0.070                  P=0.753N                 P=0.500                  P=0.181         | 
|ORDER RESTRICTED   |                  P=0.101                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 7       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Teratoma Benign                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/46 (4%)                0/48 (0%)                0/47 (0%)                0/44 (0%)       | 
|POLY-3 RATE (b)    |                  2/44.82                  0/46.24                  0/43.97                  0/43.49         | 
|POLY-3 PERCENT (g) |                  4.5%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  122                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.125N                 P=0.235N                 P=0.240N                 P=0.242N        | 
|POLY 3             |                  P=0.125N                 P=0.230N                 P=0.241N                 P=0.244N        | 
|POLY 1.5           |                  P=0.124N                 P=0.230N                 P=0.239N                 P=0.245N        | 
|POLY 6             |                  P=0.125N                 P=0.230N                 P=0.243N                 P=0.241N        | 
|LOGISTIC REGRESSION|                  P=0.173N                 P=0.389N                 P=0.197N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.125N                 P=0.237N                 P=0.242N                 P=0.258N        | 
|ORDER RESTRICTED   |                  P=0.031N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/41 (7%)                0/45 (0%)                1/44 (2%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  3/38.52                  0/43.24                  1/41.14                  2/43.65         | 
|POLY-3 PERCENT (g) |                  7.8%                     0.0%                     2.4%                     4.6%            | 
|TERMINAL (d)       |                  2/32 (6%)                0/38 (0%)                1/37 (3%)                2/38 (5%)       | 
|FIRST INCIDENCE    |                  639                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.536N                 P=0.101N                 P=0.271N                 P=0.438N        | 
|POLY 3             |                  P=0.545N                 P=0.098N                 P=0.281N                 P=0.443N        | 
|POLY 1.5           |                  P=0.544N                 P=0.099N                 P=0.280N                 P=0.442N        | 
|POLY 6             |                  P=0.546N                 P=0.098N                 P=0.282N                 P=0.443N        | 
|LOGISTIC REGRESSION|                  P=0.538N                 P=0.107N                 P=0.279N                 P=0.445N        | 
|COCH-ARM / FISHERS |                  P=0.540N                 P=0.104N                 P=0.282N                 P=0.445N        | 
|ORDER RESTRICTED   |                  P=0.147N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 8       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.52                  2/46.34                  0/44.34                  2/45.19         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      708                      ---                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.276                  P=0.268                  (e)                      P=0.259         | 
|POLY 3             |                  P=0.272                  P=0.251                  (e)                      P=0.246         | 
|POLY 1.5           |                  P=0.271                  P=0.248                  (e)                      P=0.245         | 
|POLY 6             |                  P=0.273                  P=0.255                  (e)                      P=0.247         | 
|LOGISTIC REGRESSION|                  P=0.264                  P=0.246                  (e)                      P=0.244         | 
|COCH-ARM / FISHERS |                  P=0.261                  P=0.247                  (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.123                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.52                  2/46.34                  0/44.34                  2/45.19         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      708                      ---                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.276                  P=0.268                  (e)                      P=0.259         | 
|POLY 3             |                  P=0.272                  P=0.251                  (e)                      P=0.246         | 
|POLY 1.5           |                  P=0.271                  P=0.248                  (e)                      P=0.245         | 
|POLY 6             |                  P=0.273                  P=0.255                  (e)                      P=0.247         | 
|LOGISTIC REGRESSION|                  P=0.264                  P=0.246                  (e)                      P=0.244         | 
|COCH-ARM / FISHERS |                  P=0.261                  P=0.247                  (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.123                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 9       
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                1/48 (2%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.52                  1/46.34                  0/44.34                  2/45.19         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.2%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      708                      ---                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.156                  P=0.529                  (e)                      P=0.259         | 
|POLY 3             |                  P=0.149                  P=0.513                  (e)                      P=0.246         | 
|POLY 1.5           |                  P=0.149                  P=0.510                  (e)                      P=0.245         | 
|POLY 6             |                  P=0.149                  P=0.515                  (e)                      P=0.247         | 
|LOGISTIC REGRESSION|                  P=0.146                  P=0.500                  (e)                      P=0.244         | 
|COCH-ARM / FISHERS |                  P=0.144                  P=0.500                  (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.080                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/45 (4%)                0/48 (0%)                0/47 (0%)                0/45 (0%)       | 
|POLY-3 RATE (b)    |                  2/42.32                  0/46.24                  0/43.97                  0/44.00         | 
|POLY-3 PERCENT (g) |                  4.7%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  639                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.124N                 P=0.227N                 P=0.239N                 P=0.237N        | 
|POLY 3             |                  P=0.124N                 P=0.218N                 P=0.229N                 P=0.229N        | 
|POLY 1.5           |                  P=0.124N                 P=0.217N                 P=0.227N                 P=0.229N        | 
|POLY 6             |                  P=0.123N                 P=0.219N                 P=0.231N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.127N                 P=0.235N                 P=0.231N                 P=0.253N        | 
|COCH-ARM / FISHERS |                  P=0.122N                 P=0.231N                 P=0.237N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.026N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 10      
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                2/48 (4%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/43.52                  2/46.26                  2/44.34                  1/45.09         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     4.5%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                2/39 (5%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      729                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.484                  P=0.262                  P=0.250                  P=0.511         | 
|POLY 3             |                  P=0.496                  P=0.251                  P=0.241                  P=0.507         | 
|POLY 1.5           |                  P=0.495                  P=0.248                  P=0.241                  P=0.506         | 
|POLY 6             |                  P=0.497                  P=0.254                  P=0.241                  P=0.508         | 
|LOGISTIC REGRESSION|                  P=0.491                  P=0.257                  P=0.250                  P=0.511         | 
|COCH-ARM / FISHERS |                  P=0.480                  P=0.247                  P=0.247                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.236                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                1/48 (2%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/43.52                  2/46.26                  1/44.34                  1/45.09         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     2.3%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      729                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.519                  P=0.262                  P=0.511                  P=0.511         | 
|POLY 3             |                  P=0.530                  P=0.251                  P=0.504                  P=0.507         | 
|POLY 1.5           |                  P=0.529                  P=0.248                  P=0.504                  P=0.506         | 
|POLY 6             |                  P=0.532                  P=0.254                  P=0.504                  P=0.508         | 
|LOGISTIC REGRESSION|                  P=0.524                  P=0.257                  P=0.511                  P=0.511         | 
|COCH-ARM / FISHERS |                  P=0.515                  P=0.247                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.280                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 11      
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/48 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.52                  0/46.24                  0/44.34                  0/45.09         | 
|POLY-3 PERCENT (g) |                  4.6%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  732                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.121N                 P=0.220N                 P=0.231N                 P=0.231N        | 
|POLY 3             |                  P=0.127N                 P=0.224N                 P=0.233N                 P=0.229N        | 
|POLY 1.5           |                  P=0.126N                 P=0.227N                 P=0.233N                 P=0.230N        | 
|POLY 6             |                  P=0.129N                 P=0.221N                 P=0.233N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.118N                 P=0.215N                 P=0.230N                 P=0.223N        | 
|COCH-ARM / FISHERS |                  P=0.122N                 P=0.247N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.027N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               5/48 (10%)               12/48 (25%)              6/48 (13%)      | 
|POLY-3 RATE (b)    |                  6/44.64                  5/46.24                  12/45.54                 6/45.69         | 
|POLY-3 PERCENT (g) |                  13.4%                    10.8%                    26.4%                    13.1%           | 
|TERMINAL (d)       |                  4/37 (11%)               5/41 (12%)               7/39 (18%)               3/39 (8%)       | 
|FIRST INCIDENCE    |                  225                      733 (T)                  620                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.442                  P=0.435N                 P=0.127                  P=0.577N        | 
|POLY 3             |                  P=0.431                  P=0.475N                 P=0.101                  P=0.604N        | 
|POLY 1.5           |                  P=0.430                  P=0.480N                 P=0.098                  P=0.607N        | 
|POLY 6             |                  P=0.436                  P=0.470N                 P=0.107                  P=0.600N        | 
|LOGISTIC REGRESSION|                  P=0.401                  P=0.562N                 P=0.089                  P=0.567         | 
|COCH-ARM / FISHERS |                  P=0.420                  P=0.500N                 P=0.095                  P=0.621N        | 
|ORDER RESTRICTED   |                  P=0.255                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 12      
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  16/48 (33%)              14/48 (29%)              13/48 (27%)              19/48 (40%)     | 
|POLY-3 RATE (b)    |                  16/45.97                 14/46.94                 13/45.25                 19/45.09        | 
|POLY-3 PERCENT (g) |                  34.8%                    29.8%                    28.7%                    42.1%           | 
|TERMINAL (d)       |                  10/37 (27%)              12/41 (29%)              11/39 (28%)              19/39 (49%)     | 
|FIRST INCIDENCE    |                  122                      498                      498                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.272                  P=0.314N                 P=0.296N                 P=0.409         | 
|POLY 3             |                  P=0.212                  P=0.386N                 P=0.346N                 P=0.308         | 
|POLY 1.5           |                  P=0.228                  P=0.389N                 P=0.338N                 P=0.326         | 
|POLY 6             |                  P=0.194                  P=0.390N                 P=0.359N                 P=0.283         | 
|LOGISTIC REGRESSION|                  P=0.244                  P=0.493N                 P=0.342N                 P=0.333         | 
|COCH-ARM / FISHERS |                  P=0.246                  P=0.413N                 P=0.329N                 P=0.336         | 
|ORDER RESTRICTED   |                  P=0.210                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  16/48 (33%)              11/48 (23%)              18/48 (38%)              17/48 (35%)     | 
|POLY-3 RATE (b)    |                  16/45.28                 11/46.52                 18/47.37                 17/47.13        | 
|POLY-3 PERCENT (g) |                  35.3%                    23.7%                    38.0%                    36.1%           | 
|TERMINAL (d)       |                  10/37 (27%)              8/41 (20%)               10/39 (26%)              10/39 (26%)     | 
|FIRST INCIDENCE    |                  225                      690                      193                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.316                  P=0.133N                 P=0.477                  P=0.568         | 
|POLY 3             |                  P=0.308                  P=0.159N                 P=0.480                  P=0.557         | 
|POLY 1.5           |                  P=0.298                  P=0.162N                 P=0.464                  P=0.545         | 
|POLY 6             |                  P=0.318                  P=0.157N                 P=0.497                  P=0.567         | 
|LOGISTIC REGRESSION|                  P=0.234                  P=0.191N                 P=0.385                  P=0.458         | 
|COCH-ARM / FISHERS |                  P=0.268                  P=0.182N                 P=0.416                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.349                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 13      
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR)       -                   LEUKOMALACHITE GREEN            
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  28/48 (58%)              22/48 (46%)              26/48 (54%)              32/48 (67%)     | 
|POLY-3 RATE (b)    |                  28/47.12                 22/47.21                 26/47.37                 32/47.13        | 
|POLY-3 PERCENT (g) |                  59.4%                    46.6%                    54.9%                    67.9%           | 
|TERMINAL (d)       |                  19/37 (51%)              18/41 (44%)              18/39 (46%)              25/39 (64%)     | 
|FIRST INCIDENCE    |                  122                      498                      193                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.178                  P=0.098N                 P=0.362N                 P=0.404         | 
|POLY 3             |                  P=0.107                  P=0.148N                 P=0.407N                 P=0.261         | 
|POLY 1.5           |                  P=0.108                  P=0.149N                 P=0.412N                 P=0.263         | 
|POLY 6             |                  P=0.105                  P=0.150N                 P=0.400N                 P=0.255         | 
|LOGISTIC REGRESSION|                  P=0.096                  P=0.210N                 P=0.448N                 P=0.228         | 
|COCH-ARM / FISHERS |                  P=0.111                  P=0.154N                 P=0.419N                 P=0.264         | 
|ORDER RESTRICTED   |                  P=0.107                  (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.