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TDMS Study 93029-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/18/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 14:55:01       
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: 06/18/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 14:55:01       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
Rats(FISCHER344)                                                                                                                    
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Salivary Glands                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/18/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 14:55:01       
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                                                                            
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Malignant                                                                   
Clitoral/Preputial Gland               Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
Skin                                   Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                  
                                       Sarcoma                                                                                      
Testes                                 Adenoma                                                                                      
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Mammary Gland                          Carcinoma or Adenoma                                                                         
                                       Fibroadenoma                                                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
Uterus                                 Polyp Stromal                                                                                
                                       Sarcoma Stromal or Polyp Stromal                                                             
Zymbal's Gland                         Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
===============================================================                                                                     
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)        -                   LEUKOMALACHITE GREEN     
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/47 (6%)    6/46 (13%)   2/47 (4%)    3/47 (6%)   |0/47 (0%)    0/48 (0%)    1/46 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     3/40.66      6/41.48      2/42.02      3/42.42     |0/42.64      0/44.68      1/41.67      0/42.63      | 
|POLY-3 PERCENT (g) |     7.4%         14.5%        4.8%         7.1%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    5/29 (17%)   2/33 (6%)    3/30 (10%)  |0/32 (0%)    0/36 (0%)    1/33 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     659          615          733 (T)      733 (T)     |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.237N     P=0.341      P=0.361N     P=0.549N    |P=0.670      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.311N     P=0.250      P=0.485N     P=0.643N    |P=0.655      (e)          P=0.495      (e)          | 
|POLY 1.5           |     P=0.321N     P=0.241      P=0.494N     P=0.652N    |P=0.661      (e)          P=0.493      (e)          | 
|POLY 6             |     P=0.295N     P=0.267      P=0.465N     P=0.629N    |P=0.649      (e)          P=0.500      (e)          | 
|LOGISTIC REGRESSION|     P=0.294N     P=0.254      P=0.458N     P=0.613N    |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.331N     P=0.232      P=0.500N     P=0.661N    |P=0.669      (e)          P=0.495      (e)          | 
|ORDER RESTRICTED   |     P=0.324N     (e)          (e)          (e)         |P=0.376      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    2/46 (4%)    0/47 (0%)    3/47 (6%)   |0/47 (0%)    0/48 (0%)    1/46 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/40.39      2/41.21      0/42.02      3/42.70     |0/42.64      0/44.68      1/41.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.9%         0.0%         7.0%        |0.0%         0.0%         2.4%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    1/29 (3%)    0/33 (0%)    1/30 (3%)   |0/32 (0%)    0/36 (0%)    1/33 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          697          ---          676         |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.140      P=0.279      (e)          P=0.155     |P=0.670      (e)          P=0.506      (e)          | 
|POLY 3             |     P=0.127      P=0.241      (e)          P=0.128     |P=0.655      (e)          P=0.495      (e)          | 
|POLY 1.5           |     P=0.123      P=0.237      (e)          P=0.124     |P=0.661      (e)          P=0.493      (e)          | 
|POLY 6             |     P=0.135      P=0.250      (e)          P=0.137     |P=0.649      (e)          P=0.500      (e)          | 
|LOGISTIC REGRESSION|     P=0.125      P=0.246      (e)          P=0.127     |(e)          (e)          P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.119      P=0.242      (e)          P=0.121     |P=0.669      (e)          P=0.495      (e)          | 
|ORDER RESTRICTED   |     P=0.041 *    (e)          (e)          (e)         |P=0.376      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/47 (6%)    8/46 (17%)   2/47 (4%)    7/47 (15%)  |0/47 (0%)    0/48 (0%)    2/46 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     3/40.66      8/41.62      2/42.02      7/43.02     |0/42.64      0/44.68      2/41.67      0/42.63      | 
|POLY-3 PERCENT (g) |     7.4%         19.2%        4.8%         16.3%       |0.0%         0.0%         4.8%         0.0%         | 
|TERMINAL (d)       |     2/23 (9%)    6/29 (21%)   2/33 (6%)    4/30 (13%)  |0/32 (0%)    0/36 (0%)    2/33 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     659          615          733 (T)      645         |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.439      P=0.170      P=0.361N     P=0.260     |P=0.563      (e)          P=0.245      (e)          | 
|POLY 3             |     P=0.357      P=0.103      P=0.485N     P=0.179     |P=0.545      (e)          P=0.232      (e)          | 
|POLY 1.5           |     P=0.341      P=0.097      P=0.494N     P=0.169     |P=0.553      (e)          P=0.230      (e)          | 
|POLY 6             |     P=0.384      P=0.114      P=0.465N     P=0.198     |P=0.537      (e)          P=0.236      (e)          | 
|LOGISTIC REGRESSION|     P=0.355      P=0.107      P=0.458N     P=0.176     |(e)          (e)          P=0.245      (e)          | 
|COCH-ARM / FISHERS |     P=0.327      P=0.092      P=0.500N     P=0.158     |P=0.562      (e)          P=0.242      (e)          | 
|ORDER RESTRICTED   |     P=0.159      (e)          (e)          (e)         |P=0.242      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/48 (10%)   2/47 (4%)    7/48 (15%)   3/47 (6%)   |7/47 (15%)   8/47 (17%)   3/46 (7%)    6/47 (13%)   | 
|POLY-3 RATE (b)    |     5/41.45      2/42.07      7/43.02      3/42.73     |7/43.16      8/43.85      3/41.83      6/42.84      | 
|POLY-3 PERCENT (g) |     12.1%        4.8%         16.3%        7.0%        |16.2%        18.2%        7.2%         14.0%        | 
|TERMINAL (d)       |     4/24 (17%)   2/30 (7%)    7/34 (21%)   1/30 (3%)   |7/33 (21%)   8/36 (22%)   3/35 (9%)    4/34 (12%)   | 
|FIRST INCIDENCE    |     718          733 (T)      733 (T)      658         |734 (T)      734 (T)      734 (T)      484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.400N     P=0.137N     P=0.623N     P=0.264N    |P=0.297N     P=0.575      P=0.131N     P=0.478N     | 
|POLY 3             |     P=0.482N     P=0.209N     P=0.405      P=0.339N    |P=0.310N     P=0.514      P=0.169N     P=0.506N     | 
|POLY 1.5           |     P=0.494N     P=0.217N     P=0.389      P=0.353N    |P=0.308N     P=0.500      P=0.173N     P=0.505N     | 
|POLY 6             |     P=0.464N     P=0.195N     P=0.438      P=0.317N    |P=0.309N     P=0.536      P=0.160N     P=0.501N     | 
|LOGISTIC REGRESSION|     P=0.448N     P=0.151N     P=0.556      P=0.312N    |P=0.326N     P=0.575      P=0.131N     P=0.514N     | 
|COCH-ARM / FISHERS |     P=0.508N     P=0.226N     P=0.379      P=0.369N    |P=0.302N     P=0.500      P=0.167N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.351N     (e)          (e)          (e)         |P=0.298N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/48 (13%)   0/47 (0%)    4/48 (8%)    9/47 (19%)  |2/47 (4%)    1/47 (2%)    2/46 (4%)    2/47 (4%)    | 
|POLY-3 RATE (b)    |     6/42.20      0/42.07      4/43.89      9/43.15     |2/43.65      1/43.89      2/42.05      2/42.13      | 
|POLY-3 PERCENT (g) |     14.2%        0.0%         9.1%         20.9%       |4.6%         2.3%         4.8%         4.8%         | 
|TERMINAL (d)       |     4/24 (17%)   0/30 (0%)    1/34 (3%)    7/30 (23%)  |1/33 (3%)    0/36 (0%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     564          ---          543          505         |585          725          676          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.056      P=0.011N*    P=0.248N     P=0.418     |P=0.493      P=0.474N     P=0.672N     P=0.692N     | 
|POLY 3             |     P=0.035 *    P=0.015N*    P=0.344N     P=0.301     |P=0.480      P=0.498N     P=0.681      P=0.681      | 
|POLY 1.5           |     P=0.034 *    P=0.016N*    P=0.359N     P=0.288     |P=0.488      P=0.502N     P=0.679      P=0.685      | 
|POLY 6             |     P=0.036 *    P=0.014N*    P=0.315N     P=0.322     |P=0.473      P=0.491N     P=0.687      P=0.679      | 
|LOGISTIC REGRESSION|     P=0.033 *    P=0.019N*    P=0.374N     P=0.276     |P=0.499      P=0.484N     P=0.687N     P=0.687N     | 
|COCH-ARM / FISHERS |     P=0.035 *    P=0.014N*    P=0.370N     P=0.272     |P=0.499      P=0.500N     P=0.683      P=0.692N     | 
|ORDER RESTRICTED   |     P=0.027 *    (e)          (e)          (e)         |P=0.592      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral/Preputial Gland                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     11/48 (23%)  2/47 (4%)    10/48 (21%)  12/47 (26%) |9/47 (19%)   9/47 (19%)   5/46 (11%)   8/47 (17%)   | 
|POLY-3 RATE (b)    |     11/42.26     2/42.07      10/43.89     12/43.47    |9/43.65      9/43.89      5/42.05      8/42.84      | 
|POLY-3 PERCENT (g) |     26.0%        4.8%         22.8%        27.6%       |20.6%        20.5%        11.9%        18.7%        | 
|TERMINAL (d)       |     8/24 (33%)   2/30 (7%)    7/34 (21%)   8/30 (27%)  |8/33 (24%)   8/36 (22%)   4/35 (11%)   6/34 (18%)   | 
|FIRST INCIDENCE    |     564          733 (T)      543          505         |585          725          676          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.185      P=0.003N**   P=0.237N     P=0.501N    |P=0.368N     P=0.525N     P=0.163N     P=0.479N     | 
|POLY 3             |     P=0.116      P=0.006N**   P=0.460N     P=0.532     |P=0.386N     P=0.599N     P=0.212N     P=0.517N     | 
|POLY 1.5           |     P=0.109      P=0.007N**   P=0.484N     P=0.506     |P=0.379N     P=0.597      P=0.216N     P=0.512N     | 
|POLY 6             |     P=0.127      P=0.005N**   P=0.412N     P=0.571     |P=0.390N     P=0.581N     P=0.201N     P=0.518N     | 
|LOGISTIC REGRESSION|     P=0.115      P=0.007N**   P=0.470N     P=0.515     |P=0.392N     P=0.568N     P=0.208N     P=0.510N     | 
|COCH-ARM / FISHERS |     P=0.105      P=0.008N**   P=0.500N     P=0.477     |P=0.368N     P=0.603N     P=0.205N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.116      (e)          (e)          (e)         |P=0.412N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    2/48 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |0/43.64      0/44.68      2/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.561      (e)          P=0.251      (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.542      (e)          P=0.237      (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.551      (e)          P=0.235      (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.534      (e)          P=0.242      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.251      (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.561      (e)          P=0.247      (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.247      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/48 (10%)   2/47 (4%)    1/48 (2%)    4/47 (9%)   |0/48 (0%)    0/48 (0%)    0/47 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     5/41.59      2/42.21      1/43.02      4/42.68     |0/43.64      0/44.68      0/42.77      0/42.63      | 
|POLY-3 PERCENT (g) |     12.0%        4.7%         2.3%         9.4%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     3/24 (13%)   1/30 (3%)    1/34 (3%)    3/30 (10%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     698          697          733 (T)      661         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.452N     P=0.154N     P=0.050N     P=0.389N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.525N     P=0.209N     P=0.093N     P=0.484N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.528N     P=0.217N     P=0.098N     P=0.498N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.519N     P=0.195N     P=0.083N     P=0.461N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.497N     P=0.186N     P=0.071N     P=0.454N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.532N     P=0.226N     P=0.102N     P=0.514N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.188N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    2/47 (4%)    3/48 (6%)    2/47 (4%)   |1/48 (2%)    3/48 (6%)    0/48 (0%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     2/41.86      2/42.07      3/43.02      2/42.42     |1/43.64      3/44.68      0/43.67      3/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         4.8%         7.0%         4.7%        |2.3%         6.7%         0.0%         7.0%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    3/34 (9%)    2/30 (7%)   |1/33 (3%)    3/36 (8%)    0/35 (0%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     639          733 (T)      733 (T)      733 (T)     |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.548N     P=0.647N     P=0.617      P=0.633N    |P=0.367      P=0.336      P=0.488N     P=0.315      | 
|POLY 3             |     P=0.568      P=0.692N     P=0.512      P=0.690N    |P=0.360      P=0.314      P=0.500N     P=0.297      | 
|POLY 1.5           |     P=0.561      P=0.691      P=0.504      P=0.693     |P=0.362      P=0.307      P=0.502N     P=0.299      | 
|POLY 6             |     P=0.578      P=0.684N     P=0.530      P=0.681N    |P=0.361      P=0.324      P=0.495N     P=0.296      | 
|LOGISTIC REGRESSION|     P=0.581      P=0.691      P=0.512      P=0.691     |P=0.367      P=0.336      (e)          P=0.315      | 
|COCH-ARM / FISHERS |     P=0.553      P=0.684      P=0.500      P=0.684     |P=0.368      P=0.308      P=0.500N     P=0.308      | 
|ORDER RESTRICTED   |     P=0.640      (e)          (e)          (e)         |P=0.206      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/47 (2%)    3/48 (6%)    4/47 (9%)   |1/48 (2%)    2/48 (4%)    3/48 (6%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.39      1/42.07      3/43.02      4/42.89     |1/43.64      2/44.72      3/43.96      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         7.0%         9.3%        |2.3%         4.5%         6.8%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    3/34 (9%)    2/30 (7%)   |1/33 (3%)    1/36 (3%)    2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      733 (T)      660         |734 (T)      725          657          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.092      P=0.712N     P=0.436      P=0.241     |P=0.331N     P=0.536      P=0.327      P=0.494N     | 
|POLY 3             |     P=0.073      P=0.757N     P=0.319      P=0.189     |P=0.340N     P=0.508      P=0.308      P=0.505N     | 
|POLY 1.5           |     P=0.070      P=0.760      P=0.311      P=0.181     |P=0.335N     P=0.502      P=0.303      P=0.503N     | 
|POLY 6             |     P=0.079      P=0.750N     P=0.336      P=0.203     |P=0.343N     P=0.519      P=0.317      P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.074      P=0.712N     P=0.436      P=0.182     |P=0.336N     P=0.533      P=0.303      (e)          | 
|COCH-ARM / FISHERS |     P=0.066      P=0.747      P=0.308      P=0.174     |P=0.326N     P=0.500      P=0.308      P=0.500N     | 
|ORDER RESTRICTED   |     P=0.121      (e)          (e)          (e)         |P=0.196N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/48 (0%)    1/48 (2%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |0/43.64      1/44.76      1/43.71      2/43.13      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.2%         2.3%         4.6%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          714          724          585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.156      P=0.516      P=0.517      P=0.238      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.157      P=0.505      P=0.500      P=0.234      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.158      P=0.501      P=0.498      P=0.235      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.157      P=0.511      P=0.505      P=0.236      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.163      P=0.501      P=0.504      P=0.268      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.160      P=0.500      P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.115      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    1/48 (2%)    0/47 (0%)   |0/48 (0%)    1/48 (2%)    2/48 (4%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      1/43.02      0/42.42     |0/43.64      1/44.85      2/43.96      2/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         0.0%        |0.0%         2.2%         4.6%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      ---         |---          690          657          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.695      (e)          P=0.569      (e)         |P=0.153      P=0.525      P=0.252      P=0.245      | 
|POLY 3             |     P=0.679      (e)          P=0.508      (e)         |P=0.152      P=0.505      P=0.239      P=0.232      | 
|POLY 1.5           |     P=0.674      (e)          P=0.503      (e)         |P=0.156      P=0.501      P=0.236      P=0.233      | 
|POLY 6             |     P=0.687      (e)          P=0.517      (e)         |P=0.150      P=0.512      P=0.245      P=0.232      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.569      (e)         |P=0.158      P=0.504      P=0.239      P=0.245      | 
|COCH-ARM / FISHERS |     P=0.667      (e)          P=0.500      (e)         |P=0.161      P=0.500      P=0.247      P=0.247      | 
|ORDER RESTRICTED   |     P=0.388      (e)          (e)          (e)         |P=0.151      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    1/48 (2%)    0/47 (0%)   |0/48 (0%)    2/48 (4%)    3/48 (6%)    4/48 (8%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      1/43.02      0/42.42     |0/43.64      2/44.93      3/44.00      4/43.13      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         0.0%        |0.0%         4.5%         6.8%         9.3%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    1/35 (3%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      ---         |---          690          657          585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.695      (e)          P=0.569      (e)         |P=0.048 *    P=0.262      P=0.136      P=0.066      | 
|POLY 3             |     P=0.679      (e)          P=0.508      (e)         |P=0.047 *    P=0.244      P=0.120      P=0.058      | 
|POLY 1.5           |     P=0.674      (e)          P=0.503      (e)         |P=0.048 *    P=0.239      P=0.117      P=0.059      | 
|POLY 6             |     P=0.687      (e)          P=0.517      (e)         |P=0.047 *    P=0.251      P=0.125      P=0.059      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.569      (e)         |P=0.051      P=0.238      P=0.120      P=0.064      | 
|COCH-ARM / FISHERS |     P=0.667      (e)          P=0.500      (e)         |P=0.050      P=0.247      P=0.121      P=0.059      | 
|ORDER RESTRICTED   |     P=0.388      (e)          (e)          (e)         |P=0.035 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    1/48 (2%)    4/47 (9%)   |20/48 (42%)  12/48 (25%)  12/48 (25%)  13/48 (27%)  | 
|POLY-3 RATE (b)    |     1/41.39      2/42.31      1/43.02      4/42.42     |20/44.43     12/45.62     12/44.43     13/44.18     | 
|POLY-3 PERCENT (g) |     2.4%         4.7%         2.3%         9.4%        |45.0%        26.3%        27.0%        29.4%        | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    1/34 (3%)    4/30 (13%)  |17/33 (52%)  8/36 (22%)   8/35 (23%)   9/34 (27%)   | 
|FIRST INCIDENCE    |     733 (T)      667          733 (T)      733 (T)     |589          625          599          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.151      P=0.568      P=0.682N     P=0.250     |P=0.170N     P=0.041N*    P=0.049N*    P=0.095N     | 
|POLY 3             |     P=0.122      P=0.508      P=0.752N     P=0.185     |P=0.160N     P=0.048N*    P=0.058N     P=0.094N     | 
|POLY 1.5           |     P=0.119      P=0.500      P=0.757N     P=0.179     |P=0.155N     P=0.058N     P=0.065N     P=0.098N     | 
|POLY 6             |     P=0.128      P=0.521      P=0.741N     P=0.196     |P=0.161N     P=0.036N*    P=0.047N*    P=0.084N     | 
|LOGISTIC REGRESSION|     P=0.131      P=0.508      P=0.682N     P=0.250     |P=0.164N     P=0.056N     P=0.060N     P=0.110N     | 
|COCH-ARM / FISHERS |     P=0.115      P=0.492      P=0.753N     P=0.174     |P=0.150N     P=0.065N     P=0.065N     P=0.098N     | 
|ORDER RESTRICTED   |     P=0.100      (e)          (e)          (e)         |P=0.054N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 8       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    1/48 (2%)    4/47 (9%)   |20/48 (42%)  13/48 (27%)  13/48 (27%)  15/48 (31%)  | 
|POLY-3 RATE (b)    |     1/41.39      2/42.31      1/43.02      4/42.42     |20/44.43     13/45.70     13/44.47     15/44.67     | 
|POLY-3 PERCENT (g) |     2.4%         4.7%         2.3%         9.4%        |45.0%        28.5%        29.2%        33.6%        | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    1/34 (3%)    4/30 (13%)  |17/33 (52%)  8/36 (22%)   8/35 (23%)   10/34 (29%)  | 
|FIRST INCIDENCE    |     733 (T)      667          733 (T)      733 (T)     |589          625          599          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.151      P=0.568      P=0.682N     P=0.250     |P=0.297N     P=0.066N     P=0.077N     P=0.192N     | 
|POLY 3             |     P=0.122      P=0.508      P=0.752N     P=0.185     |P=0.278N     P=0.076N     P=0.090N     P=0.185N     | 
|POLY 1.5           |     P=0.119      P=0.500      P=0.757N     P=0.179     |P=0.275N     P=0.090N     P=0.100N     P=0.195N     | 
|POLY 6             |     P=0.128      P=0.521      P=0.741N     P=0.196     |P=0.274N     P=0.058N     P=0.074N     P=0.164N     | 
|LOGISTIC REGRESSION|     P=0.131      P=0.508      P=0.682N     P=0.250     |P=0.288N     P=0.087N     P=0.092N     P=0.213N     | 
|COCH-ARM / FISHERS |     P=0.115      P=0.492      P=0.753N     P=0.174     |P=0.271N     P=0.098N     P=0.098N     P=0.198N     | 
|ORDER RESTRICTED   |     P=0.100      (e)          (e)          (e)         |P=0.108N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    2/48 (4%)    4/47 (9%)   |20/48 (42%)  13/48 (27%)  14/48 (29%)  17/48 (35%)  | 
|POLY-3 RATE (b)    |     1/41.39      2/42.31      2/43.02      4/42.42     |20/44.43     13/45.70     14/44.75     17/44.67     | 
|POLY-3 PERCENT (g) |     2.4%         4.7%         4.7%         9.4%        |45.0%        28.5%        31.3%        38.1%        | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    2/34 (6%)    4/30 (13%)  |17/33 (52%)  8/36 (22%)   8/35 (23%)   12/34 (35%)  | 
|FIRST INCIDENCE    |     733 (T)      667          733 (T)      733 (T)     |589          625          599          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.151      P=0.568      P=0.621      P=0.250     |P=0.481N     P=0.066N     P=0.115N     P=0.320N     | 
|POLY 3             |     P=0.122      P=0.508      P=0.514      P=0.185     |P=0.472N     P=0.076N     P=0.130N     P=0.325N     | 
|POLY 1.5           |     P=0.118      P=0.500      P=0.505      P=0.179     |P=0.467N     P=0.090N     P=0.144N     P=0.336N     | 
|POLY 6             |     P=0.128      P=0.521      P=0.530      P=0.196     |P=0.468N     P=0.058N     P=0.105N     P=0.297N     | 
|LOGISTIC REGRESSION|     P=0.130      P=0.508      P=0.621      P=0.250     |P=0.481N     P=0.087N     P=0.140N     P=0.362N     | 
|COCH-ARM / FISHERS |     P=0.113      P=0.492      P=0.500      P=0.174     |P=0.459N     P=0.098N     P=0.143N     P=0.338N     | 
|ORDER RESTRICTED   |     P=0.119      (e)          (e)          (e)         |P=0.169N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 9       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     30/45 (67%)  19/46 (41%)  21/48 (44%)  13/45 (29%) |26/47 (55%)  23/47 (49%)  17/45 (38%)  20/46 (43%)  | 
|POLY-3 RATE (b)    |     30/43.12     19/44.24     21/44.24     13/41.49    |26/44.34     23/45.02     17/42.82     20/41.59     | 
|POLY-3 PERCENT (g) |     69.6%        43.0%        47.5%        31.3%       |58.6%        51.1%        39.7%        48.1%        | 
|TERMINAL (d)       |     15/23 (65%)  10/30 (33%)  16/34 (47%)  11/30 (37%) |19/33 (58%)  18/35 (51%)  12/35 (34%)  17/32 (53%)  | 
|FIRST INCIDENCE    |     541          487          599          645         |627          561          599          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001N**   P=0.011N*    P=0.005N**   P<0.001N**  |P=0.166N     P=0.259N     P=0.044N*    P=0.199N     | 
|POLY 3             |     P<0.001N**   P=0.008N**   P=0.026N*    P<0.001N**  |P=0.170N     P=0.306N     P=0.056N     P=0.218N     | 
|POLY 1.5           |     P<0.001N**   P=0.010N*    P=0.024N*    P<0.001N**  |P=0.151N     P=0.335N     P=0.062N     P=0.202N     | 
|POLY 6             |     P=0.002N**   P=0.007N**   P=0.026N*    P<0.001N**  |P=0.190N     P=0.271N     P=0.048N*    P=0.236N     | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.016N*    P=0.020N*    P<0.001N**  |P=0.167N     P=0.328N     P=0.059N     P=0.223N     | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.013N*    P=0.022N*    P<0.001N**  |P=0.131N     P=0.340N     P=0.070N     P=0.175N     | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P=0.130N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    5/47 (11%)   1/48 (2%)    4/47 (9%)   |2/48 (4%)    2/48 (4%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     2/41.65      5/42.57      1/43.75      4/42.42     |2/43.64      2/44.68      0/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         11.7%        2.3%         9.4%        |4.6%         4.5%         0.0%         4.7%         | 
|TERMINAL (d)       |     1/24 (4%)    4/30 (13%)   0/34 (0%)    4/30 (13%)  |2/33 (6%)    2/36 (6%)    0/35 (0%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     662          579          477          733 (T)     |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.543      P=0.292      P=0.450N     P=0.430     |P=0.536N     P=0.664N     P=0.225N     P=0.685N     | 
|POLY 3             |     P=0.488      P=0.224      P=0.483N     P=0.345     |P=0.541N     P=0.685N     P=0.237N     P=0.686      | 
|POLY 1.5           |     P=0.478      P=0.216      P=0.492N     P=0.337     |P=0.540N     P=0.692N     P=0.239N     P=0.688      | 
|POLY 6             |     P=0.504      P=0.238      P=0.466N     P=0.358     |P=0.541N     P=0.675N     P=0.232N     P=0.686      | 
|LOGISTIC REGRESSION|     P=0.460      P=0.211      P=0.445N     P=0.374     |P=0.536N     P=0.664N     (e)          P=0.685N     | 
|COCH-ARM / FISHERS |     P=0.467      P=0.209      P=0.500N     P=0.329     |P=0.535N     P=0.692N     P=0.247N     P=0.692N     | 
|ORDER RESTRICTED   |     P=0.324      (e)          (e)          (e)         |P=0.448N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 10      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/48 (8%)    1/47 (2%)    1/48 (2%)    5/47 (11%)  |0/48 (0%)    1/48 (2%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     4/41.77      1/42.07      1/43.02      5/42.78     |0/43.64      1/44.68      0/43.67      1/43.13      | 
|POLY-3 PERCENT (g) |     9.6%         2.4%         2.3%         11.7%       |0.0%         2.2%         0.0%         2.3%         | 
|TERMINAL (d)       |     3/24 (13%)   1/30 (3%)    1/34 (3%)    2/30 (7%)   |0/33 (0%)    1/36 (3%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     623          733 (T)      733 (T)      687         |---          734 (T)      ---          585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.309      P=0.132N     P=0.105N     P=0.605     |P=0.433      P=0.517      (e)          P=0.491      | 
|POLY 3             |     P=0.250      P=0.176N     P=0.169N     P=0.515     |P=0.435      P=0.505      (e)          P=0.498      | 
|POLY 1.5           |     P=0.246      P=0.181N     P=0.175N     P=0.501     |P=0.435      P=0.501      (e)          P=0.498      | 
|POLY 6             |     P=0.255      P=0.167N     P=0.157N     P=0.538     |P=0.438      P=0.510      (e)          P=0.499      | 
|LOGISTIC REGRESSION|     P=0.261      P=0.171N     P=0.165N     P=0.517     |P=0.442      P=0.517      (e)          P=0.637      | 
|COCH-ARM / FISHERS |     P=0.244      P=0.187N     P=0.181N     P=0.486     |P=0.438      P=0.500      (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.148      (e)          (e)          (e)         |P=0.249      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/48 (8%)    5/47 (11%)   2/48 (4%)    10/47 (21%) |0/48 (0%)    3/48 (6%)    1/48 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     4/41.77      5/42.52      2/43.02      10/42.78    |0/43.64      3/44.85      1/44.41      1/43.13      | 
|POLY-3 PERCENT (g) |     9.6%         11.8%        4.7%         23.4%       |0.0%         6.7%         2.3%         2.3%         | 
|TERMINAL (d)       |     3/24 (13%)   3/30 (10%)   2/34 (6%)    7/30 (23%)  |0/33 (0%)    1/36 (3%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     623          604          733 (T)      687         |---          709          470          585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.071      P=0.607      P=0.211N     P=0.147     |P=0.589N     P=0.141      P=0.496      P=0.491      | 
|POLY 3             |     P=0.042 *    P=0.511      P=0.323N     P=0.076     |P=0.579N     P=0.123      P=0.503      P=0.498      | 
|POLY 1.5           |     P=0.040 *    P=0.499      P=0.332N     P=0.071     |P=0.582N     P=0.120      P=0.500      P=0.498      | 
|POLY 6             |     P=0.045 *    P=0.533      P=0.304N     P=0.086     |P=0.573N     P=0.129      P=0.509      P=0.499      | 
|LOGISTIC REGRESSION|     P=0.049 *    P=0.503      P=0.307N     P=0.092     |P=0.571N     P=0.123      P=0.675      P=0.637      | 
|COCH-ARM / FISHERS |     P=0.041 *    P=0.486      P=0.339N     P=0.067     |P=0.579N     P=0.121      P=0.500      P=0.500      | 
|ORDER RESTRICTED   |     P=0.025 *    (e)          (e)          (e)         |P=0.232      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 11      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    4/47 (9%)    1/48 (2%)    5/47 (11%)  |0/48 (0%)    2/48 (4%)    1/48 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      4/42.52      1/43.02      5/42.42     |0/43.64      2/44.85      1/44.41      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         9.4%         2.3%         11.8%       |0.0%         4.5%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    1/34 (3%)    5/30 (17%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          604          733 (T)      733 (T)     |---          709          470          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.090      P=0.091      P=0.569      P=0.053     |P=0.409N     P=0.260      P=0.496      (e)          | 
|POLY 3             |     P=0.071      P=0.063      P=0.508      P=0.032 *   |P=0.404N     P=0.243      P=0.503      (e)          | 
|POLY 1.5           |     P=0.067      P=0.060      P=0.503      P=0.030 *   |P=0.405N     P=0.239      P=0.500      (e)          | 
|POLY 6             |     P=0.077      P=0.068      P=0.517      P=0.035 *   |P=0.401N     P=0.251      P=0.509      (e)          | 
|LOGISTIC REGRESSION|     P=0.075      P=0.060      P=0.569      P=0.053     |P=0.392N     P=0.238      P=0.675      (e)          | 
|COCH-ARM / FISHERS |     P=0.066      P=0.056      P=0.500      P=0.026 *   |P=0.400N     P=0.247      P=0.500      (e)          | 
|ORDER RESTRICTED   |     P=0.014 *    (e)          (e)          (e)         |P=0.332      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Keratoacanthoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    3/47 (6%)    0/48 (0%)    2/47 (4%)   |0/48 (0%)    1/48 (2%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/41.65      3/42.57      0/43.02      2/42.42     |0/43.64      1/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         7.1%         0.0%         4.7%        |0.0%         2.2%         0.0%         2.4%         | 
|TERMINAL (d)       |     1/24 (4%)    2/30 (7%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    1/36 (3%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     662          579          ---          733 (T)     |---          734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.381N     P=0.567      P=0.189N     P=0.628N    |P=0.438      P=0.517      (e)          P=0.506      | 
|POLY 3             |     P=0.428N     P=0.510      P=0.230N     P=0.688N    |P=0.433      P=0.505      (e)          P=0.495      | 
|POLY 1.5           |     P=0.433N     P=0.501      P=0.234N     P=0.694     |P=0.434      P=0.501      (e)          P=0.497      | 
|POLY 6             |     P=0.420N     P=0.526      P=0.220N     P=0.677N    |P=0.433      P=0.510      (e)          P=0.495      | 
|LOGISTIC REGRESSION|     P=0.437N     P=0.480      P=0.237N     P=0.678N    |(e)          P=0.517      (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.438N     P=0.490      P=0.247N     P=0.684     |P=0.438      P=0.500      (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.325N     (e)          (e)          (e)         |P=0.247      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 12      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Lipoma                                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    3/47 (6%)    1/48 (2%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      3/42.07      1/43.16      0/42.42     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         7.1%         2.3%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    3/30 (10%)   0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      698          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.251N     P=0.162      P=0.539      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.274N     P=0.121      P=0.508      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.283N     P=0.118      P=0.503      (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.259N     P=0.127      P=0.519      (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.272N     P=0.162      P=0.501      (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.294N     P=0.117      P=0.500      (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.218N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Sarcoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    3/47 (6%)    0/48 (0%)    4/47 (9%)   |0/48 (0%)    2/48 (4%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      3/42.51      0/43.02      4/42.42     |0/43.64      2/44.85      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         7.1%         0.0%         9.4%        |0.0%         4.5%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    0/34 (0%)    4/30 (13%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          604          ---          733 (T)     |---          709          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.111      P=0.151      (e)          P=0.093     |P=0.328N     P=0.260      (e)          (e)          | 
|POLY 3             |     P=0.092      P=0.123      (e)          P=0.063     |P=0.318N     P=0.243      (e)          (e)          | 
|POLY 1.5           |     P=0.088      P=0.119      (e)          P=0.060     |P=0.322N     P=0.239      (e)          (e)          | 
|POLY 6             |     P=0.098      P=0.130      (e)          P=0.067     |P=0.312N     P=0.251      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.093      P=0.113      (e)          P=0.093     |P=0.324N     P=0.238      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.087      P=0.117      (e)          P=0.056     |P=0.321N     P=0.247      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.019 *    (e)          (e)          (e)         |P=0.257N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 13      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/47 (4%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      2/42.07      0/43.02      0/42.42     |1/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         0.0%         0.0%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      ---          ---         |734 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.285N     P=0.288      (e)          (e)         |P=0.329N     P=0.483N     P=0.488N     P=0.494N     | 
|POLY 3             |     P=0.309N     P=0.240      (e)          (e)         |P=0.331N     P=0.495N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.316N     P=0.237      (e)          (e)         |P=0.330N     P=0.499N     P=0.502N     P=0.503N     | 
|POLY 6             |     P=0.297N     P=0.248      (e)          (e)         |P=0.333N     P=0.490N     P=0.495N     P=0.505N     | 
|LOGISTIC REGRESSION|     (e)          P=0.288      (e)          (e)         |P=0.329N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.323N     P=0.242      (e)          (e)         |P=0.330N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.245N     (e)          (e)          (e)         |P=0.125N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, Squamous Cell                                                                           | 
|     Carcinoma or Keratoacanthoma                                                                                                | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    5/47 (11%)   0/48 (0%)    3/47 (6%)   |1/48 (2%)    1/48 (2%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/41.65      5/42.57      0/43.02      3/42.42     |1/43.64      1/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         11.7%        0.0%         7.1%        |2.3%         2.2%         0.0%         2.4%         | 
|TERMINAL (d)       |     1/24 (4%)    4/30 (13%)   0/34 (0%)    3/30 (10%)  |1/33 (3%)    1/36 (3%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     662          579          ---          733 (T)     |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.403N     P=0.292      P=0.189N     P=0.586     |P=0.600N     P=0.742N     P=0.488N     P=0.755N     | 
|POLY 3             |     P=0.461N     P=0.224      P=0.230N     P=0.508     |P=0.602N     P=0.755N     P=0.500N     P=0.755      | 
|POLY 1.5           |     P=0.470N     P=0.216      P=0.234N     P=0.500     |P=0.601N     P=0.760N     P=0.502N     P=0.757      | 
|POLY 6             |     P=0.447N     P=0.238      P=0.220N     P=0.522     |P=0.601N     P=0.749N     P=0.495N     P=0.756      | 
|LOGISTIC REGRESSION|     P=0.463N     P=0.211      P=0.237N     P=0.532     |P=0.600N     P=0.742N     (e)          P=0.755N     | 
|COCH-ARM / FISHERS |     P=0.477N     P=0.209      P=0.247N     P=0.490     |P=0.600N     P=0.753N     P=0.500N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.277N     (e)          (e)          (e)         |P=0.540N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 14      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    5/47 (11%)   0/48 (0%)    2/47 (4%)   |1/48 (2%)    1/48 (2%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/41.65      5/42.57      0/43.02      2/42.42     |1/43.64      1/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         11.7%        0.0%         4.7%        |2.3%         2.2%         0.0%         2.4%         | 
|TERMINAL (d)       |     1/24 (4%)    4/30 (13%)   0/34 (0%)    2/30 (7%)   |1/33 (3%)    1/36 (3%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     662          579          ---          733 (T)     |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.222N     P=0.292      P=0.189N     P=0.628N    |P=0.600N     P=0.742N     P=0.488N     P=0.755N     | 
|POLY 3             |     P=0.264N     P=0.224      P=0.230N     P=0.688N    |P=0.602N     P=0.755N     P=0.500N     P=0.755      | 
|POLY 1.5           |     P=0.271N     P=0.216      P=0.234N     P=0.694     |P=0.601N     P=0.760N     P=0.502N     P=0.757      | 
|POLY 6             |     P=0.252N     P=0.238      P=0.220N     P=0.677N    |P=0.601N     P=0.749N     P=0.495N     P=0.756      | 
|LOGISTIC REGRESSION|     P=0.271N     P=0.211      P=0.237N     P=0.678N    |P=0.600N     P=0.742N     (e)          P=0.755N     | 
|COCH-ARM / FISHERS |     P=0.280N     P=0.209      P=0.247N     P=0.684     |P=0.600N     P=0.753N     P=0.500N     P=0.753N     | 
|ORDER RESTRICTED   |     P=0.170N     (e)          (e)          (e)         |P=0.540N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     37/48 (77%)  42/47 (89%)  43/48 (90%)  45/47 (96%) |                                                    | 
|POLY-3 RATE (b)    |     37/44.86     42/45.01     43/46.62     45/47.00    |                                                    | 
|POLY-3 PERCENT (g) |     82.5%        93.3%        92.2%        95.7%       |                                                    | 
|TERMINAL (d)       |     23/24 (96%)  29/30 (97%)  32/34 (94%)  28/30 (93%) |                                                    | 
|FIRST INCIDENCE    |     564          579          435          475         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.444      P=0.428N     P=0.223N     P=0.503     |                                                    | 
|POLY 3             |     P=0.036 *    P=0.078      P=0.115      P=0.029 *   |                                                    | 
|POLY 1.5           |     P=0.018 *    P=0.080      P=0.092      P=0.015 *   |                                                    | 
|POLY 6             |     P=0.104      P=0.090      P=0.182      P=0.078     |                                                    | 
|LOGISTIC REGRESSION|     P=0.010 *    P=0.113      P=0.074      P=0.012 *   |                                                    | 
|COCH-ARM / FISHERS |     P=0.010 *    P=0.092      P=0.085      P=0.008 **  |                                                    | 
|ORDER RESTRICTED   |     P=0.009 **   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 15      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/47 (13%)   7/47 (15%)   7/48 (15%)   4/46 (9%)   |4/46 (9%)    7/46 (15%)   5/47 (11%)   5/48 (10%)   | 
|POLY-3 RATE (b)    |     6/41.54      7/42.50      7/43.43      4/41.55     |4/42.42      7/43.27      5/42.73      5/42.85      | 
|POLY-3 PERCENT (g) |     14.4%        16.5%        16.1%        9.6%        |9.4%         16.2%        11.7%        11.7%        | 
|TERMINAL (d)       |     3/24 (13%)   6/30 (20%)   5/34 (15%)   4/30 (13%)  |3/33 (9%)    6/35 (17%)   4/34 (12%)   3/34 (9%)    | 
|FIRST INCIDENCE    |     613          606          629          733 (T)     |589          725          719          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.182N     P=0.604N     P=0.532N     P=0.264N    |P=0.538N     P=0.300      P=0.518      P=0.513      | 
|POLY 3             |     P=0.266N     P=0.518      P=0.535      P=0.368N    |P=0.536N     P=0.271      P=0.505      P=0.506      | 
|POLY 1.5           |     P=0.273N     P=0.509      P=0.522      P=0.376N    |P=0.525N     P=0.262      P=0.502      P=0.513      | 
|POLY 6             |     P=0.256N     P=0.534      P=0.563      P=0.357N    |P=0.544N     P=0.285      P=0.513      P=0.503      | 
|LOGISTIC REGRESSION|     P=0.254N     P=0.517      P=0.533      P=0.352N    |P=0.542N     P=0.272      P=0.510      P=0.516      | 
|COCH-ARM / FISHERS |     P=0.279N     P=0.500      P=0.517      P=0.384N    |P=0.507N     P=0.261      P=0.514      P=0.527      | 
|ORDER RESTRICTED   |     P=0.344N     (e)          (e)          (e)         |P=0.472      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    2/47 (4%)    0/48 (0%)    0/46 (0%)   |0/46 (0%)    1/46 (2%)    1/47 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/40.81      2/42.08      0/43.02      0/41.55     |0/41.94      1/43.68      1/42.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.5%         4.8%         0.0%         0.0%        |0.0%         2.3%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/35 (0%)    1/34 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     731          729          ---          ---         |---          605          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.134N     P=0.573      P=0.446N     P=0.471N    |P=0.566N     P=0.509      P=0.506      (e)          | 
|POLY 3             |     P=0.151N     P=0.511      P=0.489N     P=0.496N    |P=0.558N     P=0.508      P=0.503      (e)          | 
|POLY 1.5           |     P=0.154N     P=0.505      P=0.493N     P=0.500N    |P=0.557N     P=0.503      P=0.502      (e)          | 
|POLY 6             |     P=0.146N     P=0.521      P=0.481N     P=0.490N    |P=0.558N     P=0.515      P=0.507      (e)          | 
|LOGISTIC REGRESSION|     P=0.138N     P=0.558      P=0.454N     P=0.476N    |P=0.547N     P=0.547      P=0.506      (e)          | 
|COCH-ARM / FISHERS |     P=0.156N     P=0.500      P=0.495N     P=0.505N    |P=0.552N     P=0.500      P=0.505      (e)          | 
|ORDER RESTRICTED   |     P=0.170N     (e)          (e)          (e)         |P=0.403N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 16      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/47 (15%)   9/47 (19%)   7/48 (15%)   4/46 (9%)   |4/46 (9%)    8/46 (17%)   6/47 (13%)   5/48 (10%)   | 
|POLY-3 RATE (b)    |     7/41.55      9/42.52      7/43.43      4/41.55     |4/42.42      8/43.71      6/42.73      5/42.85      | 
|POLY-3 PERCENT (g) |     16.9%        21.2%        16.1%        9.6%        |9.4%         18.3%        14.0%        11.7%        | 
|TERMINAL (d)       |     3/24 (13%)   7/30 (23%)   5/34 (15%)   4/30 (13%)  |3/33 (9%)    6/35 (17%)   5/34 (15%)   3/34 (9%)    | 
|FIRST INCIDENCE    |     613          606          629          733 (T)     |589          605          719          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.084N     P=0.544      P=0.405N     P=0.175N    |P=0.499N     P=0.213      P=0.389      P=0.513      | 
|POLY 3             |     P=0.135N     P=0.410      P=0.580N     P=0.259N    |P=0.499N     P=0.190      P=0.374      P=0.506      | 
|POLY 1.5           |     P=0.141N     P=0.401      P=0.592N     P=0.266N    |P=0.487N     P=0.180      P=0.371      P=0.513      | 
|POLY 6             |     P=0.126N     P=0.428      P=0.551N     P=0.247N    |P=0.509N     P=0.205      P=0.381      P=0.503      | 
|LOGISTIC REGRESSION|     P=0.124N     P=0.422      P=0.577N     P=0.240N    |P=0.491N     P=0.177      P=0.380      P=0.516      | 
|COCH-ARM / FISHERS |     P=0.146N     P=0.392      P=0.597N     P=0.274N    |P=0.465N     P=0.177      P=0.384      P=0.527      | 
|ORDER RESTRICTED   |     P=0.191N     (e)          (e)          (e)         |P=0.380      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    2/47 (4%)    0/48 (0%)    1/46 (2%)   |0/46 (0%)    0/46 (0%)    0/47 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/40.80      2/42.07      0/43.02      1/41.55     |0/41.94      0/43.24      0/42.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         0.0%         2.4%        |0.0%         0.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    0/34 (0%)    1/30 (3%)   |0/33 (0%)    0/35 (0%)    0/34 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      ---          733 (T)     |---          ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.645      P=0.288      (e)          P=0.545     |P=0.192      (e)          (e)          P=0.506      | 
|POLY 3             |     P=0.610      P=0.244      (e)          P=0.504     |P=0.191      (e)          (e)          P=0.503      | 
|POLY 1.5           |     P=0.603      P=0.240      (e)          P=0.500     |P=0.194      (e)          (e)          P=0.505      | 
|POLY 6             |     P=0.623      P=0.250      (e)          P=0.510     |P=0.189      (e)          (e)          P=0.503      | 
|LOGISTIC REGRESSION|     (e)          P=0.288      (e)          P=0.545     |(e)          (e)          (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.596      P=0.247      (e)          P=0.495     |P=0.197      (e)          (e)          P=0.511      | 
|ORDER RESTRICTED   |     P=0.329      (e)          (e)          (e)         |P=0.123      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 17      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/47 (0%)    1/48 (2%)    2/46 (4%)   |0/46 (0%)    1/46 (2%)    2/47 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/40.80      0/42.07      1/43.28      2/41.55     |0/41.94      1/43.25      2/42.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         4.8%        |0.0%         2.3%         4.7%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    0/35 (0%)    2/34 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          662          733 (T)     |---          732          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.072      (e)          P=0.526      P=0.288     |P=0.598N     P=0.523      P=0.245      (e)          | 
|POLY 3             |     P=0.064      (e)          P=0.512      P=0.241     |P=0.601N     P=0.506      P=0.241      (e)          | 
|POLY 1.5           |     P=0.062      (e)          P=0.507      P=0.237     |P=0.597N     P=0.502      P=0.239      (e)          | 
|POLY 6             |     P=0.066      (e)          P=0.521      P=0.248     |P=0.605N     P=0.512      P=0.245      (e)          | 
|LOGISTIC REGRESSION|     P=0.063      (e)          P=0.512      P=0.288     |P=0.601N     P=0.519      P=0.245      (e)          | 
|COCH-ARM / FISHERS |     P=0.061      (e)          P=0.505      P=0.242     |P=0.589N     P=0.500      P=0.253      (e)          | 
|ORDER RESTRICTED   |     P=0.076      (e)          (e)          (e)         |P=0.328N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    2/47 (4%)    1/48 (2%)    3/46 (7%)   |0/46 (0%)    1/46 (2%)    2/47 (4%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/40.80      2/42.07      1/43.28      3/41.55     |0/41.94      1/43.25      2/42.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         2.3%         7.2%        |0.0%         2.3%         4.7%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    0/34 (0%)    3/30 (10%)  |0/33 (0%)    0/35 (0%)    2/34 (6%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      662          733 (T)     |---          732          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.145      P=0.288      P=0.526      P=0.162     |P=0.373      P=0.523      P=0.245      P=0.506      | 
|POLY 3             |     P=0.122      P=0.244      P=0.512      P=0.121     |P=0.367      P=0.506      P=0.241      P=0.503      | 
|POLY 1.5           |     P=0.118      P=0.240      P=0.507      P=0.118     |P=0.374      P=0.502      P=0.239      P=0.505      | 
|POLY 6             |     P=0.129      P=0.250      P=0.521      P=0.127     |P=0.361      P=0.512      P=0.245      P=0.503      | 
|LOGISTIC REGRESSION|     P=0.125      P=0.288      P=0.512      P=0.162     |P=0.370      P=0.519      P=0.245      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.115      P=0.247      P=0.505      P=0.117     |P=0.384      P=0.500      P=0.253      P=0.511      | 
|ORDER RESTRICTED   |     P=0.058      (e)          (e)          (e)         |P=0.229      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 18      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |10/48 (21%)  12/48 (25%)  19/48 (40%)  17/48 (35%)  | 
|POLY-3 RATE (b)    |                                                        |10/44.43     12/44.69     19/45.15     17/43.63     | 
|POLY-3 PERCENT (g) |                                                        |22.5%        26.9%        42.1%        39.0%        | 
|TERMINAL (d)       |                                                        |8/33 (24%)   11/36 (31%)  14/35 (40%)  13/34 (38%)  | 
|FIRST INCIDENCE    |                                                        |585          732          482          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.047 *    P=0.491      P=0.062      P=0.103      | 
|POLY 3             |                                                        |P=0.035 *    P=0.409      P=0.037 *    P=0.071      | 
|POLY 1.5           |                                                        |P=0.039 *    P=0.398      P=0.034 *    P=0.075      | 
|POLY 6             |                                                        |P=0.034 *    P=0.426      P=0.044 *    P=0.071      | 
|LOGISTIC REGRESSION|                                                        |P=0.037 *    P=0.448      P=0.036 *    P=0.075      | 
|COCH-ARM / FISHERS |                                                        |P=0.046 *    P=0.404      P=0.037 *    P=0.086      | 
|ORDER RESTRICTED   |                                                        |P=0.049 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |11/48 (23%)  12/48 (25%)  19/48 (40%)  18/48 (38%)  | 
|POLY-3 RATE (b)    |                                                        |11/44.43     12/44.69     19/45.15     18/44.24     | 
|POLY-3 PERCENT (g) |                                                        |24.8%        26.9%        42.1%        40.7%        | 
|TERMINAL (d)       |                                                        |9/33 (27%)   11/36 (31%)  14/35 (40%)  13/34 (38%)  | 
|FIRST INCIDENCE    |                                                        |585          732          482          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.043 *    P=0.590      P=0.095      P=0.110      | 
|POLY 3             |                                                        |P=0.035 *    P=0.506      P=0.062      P=0.082      | 
|POLY 1.5           |                                                        |P=0.037 *    P=0.494      P=0.057      P=0.083      | 
|POLY 6             |                                                        |P=0.036 *    P=0.525      P=0.073      P=0.085      | 
|LOGISTIC REGRESSION|                                                        |P=0.035 *    P=0.550      P=0.059      P=0.084      | 
|COCH-ARM / FISHERS |                                                        |P=0.041 *    P=0.500      P=0.061      P=0.091      | 
|ORDER RESTRICTED   |                                                        |P=0.070      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 19      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |0/43.64      0/44.68      0/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.043 *    (e)          (e)          P=0.245      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.041 *    (e)          (e)          P=0.232      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.042 *    (e)          (e)          P=0.233      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.041 *    (e)          (e)          P=0.232      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.245      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.027 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Zymbal's Gland                                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/48 (0%)    1/47 (2%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     1/41.75      0/42.07      0/43.02      1/42.74     |0/43.64      0/44.68      0/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         2.3%        |0.0%         0.0%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     632          ---          ---          645         |---          ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.590      P=0.505N     P=0.490N     P=0.733N    |P=0.043 *    (e)          (e)          P=0.245      | 
|POLY 3             |     P=0.563      P=0.498N     P=0.494N     P=0.756N    |P=0.041 *    (e)          (e)          P=0.232      | 
|POLY 1.5           |     P=0.561      P=0.501N     P=0.498N     P=0.760N    |P=0.042 *    (e)          (e)          P=0.233      | 
|POLY 6             |     P=0.565      P=0.493N     P=0.486N     P=0.748N    |P=0.041 *    (e)          (e)          P=0.232      | 
|LOGISTIC REGRESSION|     P=0.559      P=0.509N     P=0.473N     P=0.751     |(e)          (e)          (e)          P=0.245      | 
|COCH-ARM / FISHERS |     P=0.560      P=0.505N     P=0.500N     P=0.747     |P=0.044 *    (e)          (e)          P=0.247      | 
|ORDER RESTRICTED   |     P=0.393N     (e)          (e)          (e)         |P=0.027 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 20      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or                                                                           | 
|     Undifferentiated                                                                                                            | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/48 (60%)  16/47 (34%)  19/48 (40%)  7/47 (15%)  |17/48 (35%)  8/48 (17%)   5/48 (10%)   8/48 (17%)   | 
|POLY-3 RATE (b)    |     29/45.63     16/43.73     19/45.63     7/43.71     |17/45.99     8/44.96      5/45.33      8/44.06      | 
|POLY-3 PERCENT (g) |     63.6%        36.6%        41.6%        16.0%       |37.0%        17.8%        11.0%        18.2%        | 
|TERMINAL (d)       |     12/24 (50%)  9/30 (30%)   9/34 (27%)   2/30 (7%)   |8/33 (24%)   6/36 (17%)   1/35 (3%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     564          579          435          601         |552          683          482          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001N**   P=0.006N**   P=0.011N*    P<0.001N**  |P=0.053N     P=0.029N*    P=0.007N**   P=0.048N*    | 
|POLY 3             |     P<0.001N**   P=0.007N**   P=0.026N*    P<0.001N**  |P=0.038N*    P=0.033N*    P=0.003N**   P=0.037N*    | 
|POLY 1.5           |     P<0.001N**   P=0.007N**   P=0.029N*    P<0.001N**  |P=0.036N*    P=0.033N*    P=0.003N**   P=0.034N*    | 
|POLY 6             |     P<0.001N**   P=0.008N**   P=0.022N*    P<0.001N**  |P=0.039N*    P=0.032N*    P=0.003N**   P=0.040N*    | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.009N**   P=0.035N*    P<0.001N**  |P=0.033N*    P=0.031N*    P=0.002N**   P=0.023N*    | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.009N**   P=0.033N*    P<0.001N**  |P=0.037N*    P=0.031N*    P=0.003N**   P=0.031N*    | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |P=0.005N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Benign, Malignant, NOS                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    1/48 (2%)    1/47 (2%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.80      0/42.07      1/43.02      1/43.14     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         2.3%         2.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     613          ---          733 (T)      475         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.517N     P=0.218N     P=0.420N     P=0.474N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.543N     P=0.235N     P=0.490N     P=0.489N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.544N     P=0.239N     P=0.496N     P=0.497N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.541N     P=0.229N     P=0.476N     P=0.477N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.554N     P=0.251N     P=0.501N     P=0.511N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.547N     P=0.253N     P=0.500N     P=0.508N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.261N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 21      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Mesothelioma: Malignant                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    1/48 (2%)    1/47 (2%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.80      0/42.07      1/43.02      1/43.14     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         2.3%         2.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     613          ---          733 (T)      475         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.517N     P=0.218N     P=0.420N     P=0.474N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.543N     P=0.235N     P=0.490N     P=0.489N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.544N     P=0.239N     P=0.496N     P=0.497N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.541N     P=0.229N     P=0.476N     P=0.477N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.554N     P=0.251N     P=0.501N     P=0.511N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.547N     P=0.253N     P=0.500N     P=0.508N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.261N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     45/48 (94%)  47/47 (100%) 47/48 (98%)  47/47 (100%)|41/48 (85%)  43/48 (90%)  37/48 (77%)  38/48 (79%)  | 
|POLY-3 RATE (b)    |     45/47.39     47/47.00     47/47.22     47/47.00    |41/46.56     43/46.81     37/45.89     38/45.85     | 
|POLY-3 PERCENT (g) |     95.0%        100.0%       99.6%        100.0%      |88.1%        91.9%        80.6%        82.9%        | 
|TERMINAL (d)       |     24/24 (100%) 30/30 (100%) 34/34 (100%) 30/30 (100%)|29/33 (88%)  33/36 (92%)  27/35 (77%)  29/34 (85%)  | 
|FIRST INCIDENCE    |     541          487          435          475         |585          561          482          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.222N     P=0.241N     P=0.064N     P=0.230N    |P=0.235N     P=0.468N     P=0.181N     P=0.313N     | 
|POLY 3             |     P=0.094      P=0.166      P=0.208      P=0.166     |P=0.140N     P=0.390      P=0.237N     P=0.334N     | 
|POLY 1.5           |     P=0.092      P=0.143      P=0.231      P=0.143     |P=0.126N     P=0.340      P=0.254N     P=0.323N     | 
|POLY 6             |     P=0.116      P=0.209      P=0.219      P=0.209     |P=0.155N     P=0.461      P=0.208N     P=0.342N     | 
|LOGISTIC REGRESSION|     P=0.096      P=0.131      P=0.226      P=0.134     |P=0.170N     P=0.366      P=0.258N     P=0.381N     | 
|COCH-ARM / FISHERS |     P=0.113      P=0.125      P=0.308      P=0.125     |P=0.121N     P=0.379      P=0.217N     P=0.297N     | 
|ORDER RESTRICTED   |     P=0.012 *    (e)          (e)          (e)         |P=0.187N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/18/03                           EXPERIMENT: 93029 TEST: 03                                            Page 22      
                     Statistical Analysis of Primary Tumors in Rats(FISCHER344)       -                   LEUKOMALACHITE GREEN      
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     34/48 (71%)  23/47 (49%)  25/48 (52%)  26/47 (55%) |21/48 (44%)  16/48 (33%)  19/48 (40%)  15/48 (31%)  | 
|POLY-3 RATE (b)    |     34/46.06     23/44.59     25/47.22     26/46.40    |21/47.00     16/46.06     19/47.60     15/44.67     | 
|POLY-3 PERCENT (g) |     73.8%        51.6%        53.0%        56.0%       |44.7%        34.7%        39.9%        33.6%        | 
|TERMINAL (d)       |     15/24 (63%)  13/30 (43%)  12/34 (35%)  13/30 (43%) |10/33 (30%)  7/36 (19%)   10/35 (29%)  9/34 (27%)   | 
|FIRST INCIDENCE    |     564          579          435          475         |552          605          102          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.111N     P=0.014N*    P=0.015N*    P=0.044N*   |P=0.253N     P=0.175N     P=0.383N     P=0.179N     | 
|POLY 3             |     P=0.132N     P=0.020N*    P=0.027N*    P=0.054N    |P=0.242N     P=0.221N     P=0.397N     P=0.190N     | 
|POLY 1.5           |     P=0.156N     P=0.021N*    P=0.035N*    P=0.066N    |P=0.220N     P=0.223N     P=0.407N     P=0.172N     | 
|POLY 6             |     P=0.110N     P=0.020N*    P=0.019N*    P=0.043N*   |P=0.269N     P=0.214N     P=0.383N     P=0.212N     | 
|LOGISTIC REGRESSION|     P=0.232N     P=0.025N*    P=0.056N     P=0.119N    |P=0.159N     P=0.198N     P=0.515N     P=0.114N     | 
|COCH-ARM / FISHERS |     P=0.195N     P=0.024N*    P=0.046N*    P=0.088N    |P=0.198N     P=0.201N     P=0.418N     P=0.146N     | 
|ORDER RESTRICTED   |     P=0.030N*    (e)          (e)          (e)         |P=0.218N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     48/48 (100%) 47/47 (100%) 47/48 (98%)  47/47 (100%)|46/48 (96%)  46/48 (96%)  42/48 (88%)  43/48 (90%)  | 
|POLY-3 RATE (b)    |     48/48.00     47/47.00     47/47.22     47/47.00    |46/48.00     46/47.00     42/48.00     43/47.17     | 
|POLY-3 PERCENT (g) |     100.0%       100.0%       99.6%        100.0%      |95.8%        97.9%        87.5%        91.2%        | 
|TERMINAL (d)       |     24/24 (100%) 30/30 (100%) 34/34 (100%) 30/30 (100%)|31/33 (94%)  35/36 (97%)  29/35 (83%)  30/34 (88%)  | 
|FIRST INCIDENCE    |     541          487          435          475         |552          561          102          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.125N     (e)          P=0.023N*    (e)         |P=0.307N     P=0.310N     P=0.190N     P=0.331N     | 
|POLY 3             |     P=0.998N     (e)          P=1.000N     (e)         |P=0.111N     P=0.507      P=0.134N     P=0.305N     | 
|POLY 1.5           |     P=0.883N     (e)          P=0.874N     (e)         |P=0.096N     P=0.513      P=0.134N     P=0.274N     | 
|POLY 6             |     P=1.000N     (e)          P=1.000N     (e)         |P=0.122N     P=0.507      P=0.134N     P=0.324N     | 
|LOGISTIC REGRESSION|     P=0.999      (e)          (e)          (e)         |P=0.104N     P=0.591      (e)          P=0.234N     | 
|COCH-ARM / FISHERS |     P=0.667N     (e)          P=0.500N     (e)         |P=0.098N     P=0.692N     P=0.134N     P=0.218N     | 
|ORDER RESTRICTED   |     P=0.380N     (e)          (e)          (e)         |P=0.109N     (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).