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TDMS Study 93005-03 Pathology Tables

                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                      REPORT: PEIRPT10     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 05/05/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 15:11:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     MALACHITE GREEN                                                                              
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Angiectasis                                                                                  
                                       Atrophy                                                                                      
Bone Marrow: Myeloid Cell              Hyperplasia                                                                                  
Bone: Turbinate                        Osteopetrosis                                                                                
Brain: Hypothalamus                    Compression                                                                                  
Clitoral Gland                         Inflammation                                                                                 
Eye                                    Cataract                                                                                     
Eye: Retina                            Degeneration                                                                                 
Heart                                  Cardiomyopathy                                                                               
Liver                                  Eosinophilic Focus                                                                           
                                       Infiltration Cellular Lymphocyte                                                             
Liver: Centrilobular                   Necrosis                                                                                     
Lung                                   Foreign Body                                                                                 
                                       Hemorrhage                                                                                   
                                       Inflammation Chronic Focal                                                                   
Lymph Node, Mesenteric                 Hyperplasia Lymphoid                                                                         
Lymph Node: Lumbar                     Ectasia                                                                                      
Mammary Gland: Duct                    Dilatation                                                                                   
Nose: Nasolacrimal Duct                Inflammation                                                                                 
Ovary                                  Atrophy                                                                                      
                                       Cyst                                                                                         
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Skin                                   Hyperkeratosis                                                                               
Spleen                                 Hematopoietic Cell Proliferation                                                             
Thyroid Gland: Follicle                Cyst                                                                                         
Vagina                                 Prolapse                                                                                     
===============================================================                                                                     
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                      MALACHITE GREEN                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/48 (21%)              11/48 (23%)              17/48 (35%)              16/48 (33%)     | 
|POLY-3 RATE (b)    |                  10/40.15                 11/38.79                 17/44.28                 16/38.40        | 
|POLY-3 PERCENT (g) |                  24.9%                    28.4%                    38.4%                    41.7%           | 
|TERMINAL (d)       |                  9/29 (31%)               9/23 (39%)               14/32 (44%)              11/25 (44%)     | 
|FIRST INCIDENCE    |                  704                      591                      627                      619             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.043 *                P=0.283                  P=0.146                  P=0.056         | 
|POLY 3             |                  P=0.048 *                P=0.463                  P=0.134                  P=0.085         | 
|POLY 1.5           |                  P=0.049 *                P=0.481                  P=0.112                  P=0.094         | 
|POLY 6             |                  P=0.051                  P=0.434                  P=0.164                  P=0.080         | 
|LOGISTIC REGRESSION|                  P=0.037 *                P=0.378                  P=0.152                  P=0.058         | 
|COCH-ARM / FISHERS |                  P=0.066                  P=0.500                  P=0.086                  P=0.125         | 
|ORDER RESTRICTED   |                  P=0.086                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  0/43.37                  2/37.30         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.4%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      697             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.037 *                (e)                      (e)                      P=0.206         | 
|POLY 3             |                  P=0.042 *                (e)                      (e)                      P=0.221         | 
|POLY 1.5           |                  P=0.042 *                (e)                      (e)                      P=0.225         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.216         | 
|LOGISTIC REGRESSION|                  P=0.038 *                (e)                      (e)                      P=0.213         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.024 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                4/48 (8%)                1/48 (2%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  4/38.24                  1/43.37                  4/37.56         | 
|POLY-3 PERCENT (g) |                  2.5%                     10.5%                    2.3%                     10.7%           | 
|TERMINAL (d)       |                  1/29 (3%)                4/23 (17%)               1/32 (3%)                3/25 (12%)      | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  728 (T)                  619             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.243                  P=0.113                  P=0.740N                 P=0.142         | 
|POLY 3             |                  P=0.248                  P=0.163                  P=0.743N                 P=0.158         | 
|POLY 1.5           |                  P=0.250                  P=0.171                  P=0.750N                 P=0.164         | 
|POLY 6             |                  P=0.246                  P=0.152                  P=0.736N                 P=0.152         | 
|LOGISTIC REGRESSION|                  P=0.233                  P=0.113                  P=0.740N                 P=0.151         | 
|COCH-ARM / FISHERS |                  P=0.262                  P=0.181                  P=0.753N                 P=0.181         | 
|ORDER RESTRICTED   |                  P=0.108                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               5/48 (10%)               2/48 (4%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  6/40.41                  5/39.42                  2/43.58                  3/37.31         | 
|POLY-3 PERCENT (g) |                  14.9%                    12.7%                    4.6%                     8.0%            | 
|TERMINAL (d)       |                  3/29 (10%)               2/23 (9%)                1/32 (3%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  667                      485                      673                      694             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.160N                 P=0.609N                 P=0.110N                 P=0.328N        | 
|POLY 3             |                  P=0.145N                 P=0.518N                 P=0.108N                 P=0.280N        | 
|POLY 1.5           |                  P=0.146N                 P=0.508N                 P=0.118N                 P=0.269N        | 
|POLY 6             |                  P=0.143N                 P=0.534N                 P=0.100N                 P=0.295N        | 
|LOGISTIC REGRESSION|                  P=0.148N                 P=0.519N                 P=0.104N                 P=0.296N        | 
|COCH-ARM / FISHERS |                  P=0.139N                 P=0.500N                 P=0.134N                 P=0.243N        | 
|ORDER RESTRICTED   |                  P=0.161N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                3/47 (6%)                1/48 (2%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  1/39.06                  3/37.78                  1/43.37                  1/37.18         | 
|POLY-3 PERCENT (g) |                  2.6%                     7.9%                     2.3%                     2.7%            | 
|TERMINAL (d)       |                  1/28 (4%)                2/23 (9%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  728 (T)                  718                      728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.400N                 P=0.243                  P=0.732N                 P=0.737         | 
|POLY 3             |                  P=0.395N                 P=0.292                  P=0.737N                 P=0.750         | 
|POLY 1.5           |                  P=0.394N                 P=0.299                  P=0.744N                 P=0.754         | 
|POLY 6             |                  P=0.396N                 P=0.283                  P=0.729N                 P=0.745         | 
|LOGISTIC REGRESSION|                  P=0.409N                 P=0.262                  P=0.732N                 P=0.737         | 
|COCH-ARM / FISHERS |                  P=0.384N                 P=0.308                  P=0.747N                 P=0.747N        | 
|ORDER RESTRICTED   |                  P=0.429N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                3/48 (6%)                2/48 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  3/38.79                  2/43.37                  2/38.29         | 
|POLY-3 PERCENT (g) |                  2.5%                     7.7%                     4.6%                     5.2%            | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  574                      728 (T)                  443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.511                  P=0.256                  P=0.535                  P=0.464         | 
|POLY 3             |                  P=0.516                  P=0.293                  P=0.528                  P=0.484         | 
|POLY 1.5           |                  P=0.517                  P=0.299                  P=0.517                  P=0.487         | 
|POLY 6             |                  P=0.515                  P=0.284                  P=0.539                  P=0.481         | 
|LOGISTIC REGRESSION|                  P=0.546                  P=0.294                  P=0.535                  P=0.560         | 
|COCH-ARM / FISHERS |                  P=0.531                  P=0.308                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.402                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Myelofibrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  2/43.58                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      673                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.555                  (e)                      P=0.270                  (e)             | 
|POLY 3             |                  P=0.515                  (e)                      P=0.256                  (e)             | 
|POLY 1.5           |                  P=0.528                  (e)                      P=0.249                  (e)             | 
|POLY 6             |                  P=0.502                  (e)                      P=0.265                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.554                  (e)                      P=0.248                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.562                  (e)                      P=0.247                  (e)             | 
|ORDER RESTRICTED   |                  P=0.265                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow: Myeloid Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               0/48 (0%)                5/48 (10%)               4/48 (8%)       | 
|POLY-3 RATE (b)    |                  5/40.83                  0/38.24                  5/44.08                  4/38.06         | 
|POLY-3 PERCENT (g) |                  12.3%                    0.0%                     11.3%                    10.5%           | 
|TERMINAL (d)       |                  4/29 (14%)               0/23 (0%)                4/32 (13%)               2/25 (8%)       | 
|FIRST INCIDENCE    |                  443                      ---                      484                      454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.354                  P=0.051N                 P=0.576N                 P=0.578N        | 
|POLY 3             |                  P=0.370                  P=0.035N*                P=0.582N                 P=0.544N        | 
|POLY 1.5           |                  P=0.367                  P=0.033N*                P=0.601N                 P=0.532N        | 
|POLY 6             |                  P=0.377                  P=0.039N*                P=0.562N                 P=0.557N        | 
|LOGISTIC REGRESSION|                  P=0.386                  P=0.033N*                P=0.594                  P=0.501N        | 
|COCH-ARM / FISHERS |                  P=0.381                  P=0.028N*                P=0.630N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.361N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                0/48 (0%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  1/38.65                  0/43.37                  3/37.99         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     0.0%                     7.9%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/23 (0%)                0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  728 (T)                  610                      ---                      589             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.153                  P=0.722                  P=0.480N                 P=0.268         | 
|POLY 3             |                  P=0.161                  P=0.753                  P=0.484N                 P=0.286         | 
|POLY 1.5           |                  P=0.159                  P=0.757                  P=0.490N                 P=0.290         | 
|POLY 6             |                  P=0.164                  P=0.747                  P=0.478N                 P=0.282         | 
|LOGISTIC REGRESSION|                  P=0.171                  P=0.762N                 (e)                      P=0.297         | 
|COCH-ARM / FISHERS |                  P=0.161                  P=0.753N                 P=0.500N                 P=0.308         | 
|ORDER RESTRICTED   |                  P=0.088                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/48 (17%)               3/48 (6%)                3/48 (6%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  8/40.99                  3/38.69                  3/43.43                  3/37.72         | 
|POLY-3 PERCENT (g) |                  19.5%                    7.8%                     6.9%                     8.0%            | 
|TERMINAL (d)       |                  5/29 (17%)               2/23 (9%)                2/32 (6%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  529                      596                      715                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.122N                 P=0.172N                 P=0.078N                 P=0.150N        | 
|POLY 3             |                  P=0.110N                 P=0.114N                 P=0.079N                 P=0.123N        | 
|POLY 1.5           |                  P=0.113N                 P=0.106N                 P=0.086N                 P=0.116N        | 
|POLY 6             |                  P=0.106N                 P=0.127N                 P=0.073N                 P=0.133N        | 
|LOGISTIC REGRESSION|                  P=0.118N                 P=0.110N                 P=0.081N                 P=0.116N        | 
|COCH-ARM / FISHERS |                  P=0.111N                 P=0.099N                 P=0.099N                 P=0.099N        | 
|ORDER RESTRICTED   |                  P=0.060N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/48 (17%)               3/48 (6%)                3/48 (6%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  8/40.99                  3/38.69                  3/43.43                  3/37.72         | 
|POLY-3 PERCENT (g) |                  19.5%                    7.8%                     6.9%                     8.0%            | 
|TERMINAL (d)       |                  5/29 (17%)               2/23 (9%)                2/32 (6%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  529                      596                      715                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.122N                 P=0.172N                 P=0.078N                 P=0.150N        | 
|POLY 3             |                  P=0.110N                 P=0.114N                 P=0.079N                 P=0.123N        | 
|POLY 1.5           |                  P=0.113N                 P=0.106N                 P=0.086N                 P=0.116N        | 
|POLY 6             |                  P=0.106N                 P=0.127N                 P=0.073N                 P=0.133N        | 
|LOGISTIC REGRESSION|                  P=0.118N                 P=0.110N                 P=0.081N                 P=0.116N        | 
|COCH-ARM / FISHERS |                  P=0.111N                 P=0.099N                 P=0.099N                 P=0.099N        | 
|ORDER RESTRICTED   |                  P=0.060N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Turbinate                                                                                                                  | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/48 (15%)               2/48 (4%)                2/48 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  7/40.99                  2/38.69                  2/43.43                  2/37.72         | 
|POLY-3 PERCENT (g) |                  17.1%                    5.2%                     4.6%                     5.3%            | 
|TERMINAL (d)       |                  4/29 (14%)               1/23 (4%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  529                      596                      715                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.092N                 P=0.134N                 P=0.065N                 P=0.119N        | 
|POLY 3             |                  P=0.080N                 P=0.091N                 P=0.064N                 P=0.098N        | 
|POLY 1.5           |                  P=0.083N                 P=0.085N                 P=0.070N                 P=0.092N        | 
|POLY 6             |                  P=0.076N                 P=0.101N                 P=0.060N                 P=0.105N        | 
|LOGISTIC REGRESSION|                  P=0.086N                 P=0.084N                 P=0.071N                 P=0.088N        | 
|COCH-ARM / FISHERS |                  P=0.084N                 P=0.079N                 P=0.079N                 P=0.079N        | 
|ORDER RESTRICTED   |                  P=0.033N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain: Hypothalamus                                                                                                              | 
|     Compression                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               14/48 (29%)              10/48 (21%)              7/48 (15%)      | 
|POLY-3 RATE (b)    |                  5/40.94                  14/41.88                 10/45.35                 7/37.48         | 
|POLY-3 PERCENT (g) |                  12.2%                    33.4%                    22.1%                    18.7%           | 
|TERMINAL (d)       |                  1/29 (3%)                4/23 (17%)               2/32 (6%)                5/25 (20%)      | 
|FIRST INCIDENCE    |                  606                      485                      603                      685             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.463N                 P=0.015 *                P=0.213                  P=0.289         | 
|POLY 3             |                  P=0.499N                 P=0.018 *                P=0.179                  P=0.316         | 
|POLY 1.5           |                  P=0.478N                 P=0.018 *                P=0.158                  P=0.336         | 
|POLY 6             |                  P=0.521N                 P=0.018 *                P=0.206                  P=0.292         | 
|LOGISTIC REGRESSION|                  P=0.422N                 P=0.022 *                P=0.101                  P=0.321         | 
|COCH-ARM / FISHERS |                  P=0.420N                 P=0.019 *                P=0.130                  P=0.379         | 
|ORDER RESTRICTED   |                  P=0.140                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               4/48 (8%)                2/47 (4%)                6/47 (13%)      | 
|POLY-3 RATE (b)    |                  5/40.12                  4/38.77                  2/42.50                  6/36.99         | 
|POLY-3 PERCENT (g) |                  12.5%                    10.3%                    4.7%                     16.2%           | 
|TERMINAL (d)       |                  4/29 (14%)               2/23 (9%)                1/31 (3%)                5/25 (20%)      | 
|FIRST INCIDENCE    |                  711                      598                      697                      605             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.378                  P=0.618N                 P=0.189N                 P=0.396         | 
|POLY 3             |                  P=0.389                  P=0.522N                 P=0.192N                 P=0.442         | 
|POLY 1.5           |                  P=0.386                  P=0.511N                 P=0.205N                 P=0.452         | 
|POLY 6             |                  P=0.395                  P=0.538N                 P=0.180N                 P=0.432         | 
|LOGISTIC REGRESSION|                  P=0.370                  P=0.553N                 P=0.176N                 P=0.413         | 
|COCH-ARM / FISHERS |                  P=0.397                  P=0.500N                 P=0.226N                 P=0.485         | 
|ORDER RESTRICTED   |                  P=0.250                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/48 (44%)              30/48 (63%)              23/47 (49%)              26/47 (55%)     | 
|POLY-3 RATE (b)    |                  21/43.51                 30/43.08                 23/44.45                 26/39.79        | 
|POLY-3 PERCENT (g) |                  48.3%                    69.6%                    51.8%                    65.3%           | 
|TERMINAL (d)       |                  12/29 (41%)              17/23 (74%)              15/31 (48%)              17/25 (68%)     | 
|FIRST INCIDENCE    |                  443                      494                      508                      454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.344                  P=0.019 *                P=0.565                  P=0.105         | 
|POLY 3             |                  P=0.232                  P=0.029 *                P=0.454                  P=0.081         | 
|POLY 1.5           |                  P=0.260                  P=0.036 *                P=0.426                  P=0.103         | 
|POLY 6             |                  P=0.211                  P=0.023 *                P=0.482                  P=0.063         | 
|LOGISTIC REGRESSION|                  P=0.301                  P=0.043 *                P=0.400                  P=0.120         | 
|COCH-ARM / FISHERS |                  P=0.361                  P=0.051                  P=0.382                  P=0.178         | 
|ORDER RESTRICTED   |                  P=0.078                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               5/48 (10%)               7/47 (15%)               6/47 (13%)      | 
|POLY-3 RATE (b)    |                  6/40.98                  5/39.93                  7/43.61                  6/37.61         | 
|POLY-3 PERCENT (g) |                  14.6%                    12.5%                    16.1%                    16.0%           | 
|TERMINAL (d)       |                  4/29 (14%)               1/23 (4%)                3/31 (10%)               3/25 (12%)      | 
|FIRST INCIDENCE    |                  533                      540                      603                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.453                  P=0.600N                 P=0.575                  P=0.528         | 
|POLY 3             |                  P=0.426                  P=0.518N                 P=0.548                  P=0.560         | 
|POLY 1.5           |                  P=0.431                  P=0.510N                 P=0.523                  P=0.571         | 
|POLY 6             |                  P=0.426                  P=0.531N                 P=0.577                  P=0.550         | 
|LOGISTIC REGRESSION|                  P=0.469                  P=0.487N                 P=0.456                  P=0.581         | 
|COCH-ARM / FISHERS |                  P=0.462                  P=0.500N                 P=0.483                  P=0.605         | 
|ORDER RESTRICTED   |                  P=0.599                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/47 (17%)               3/48 (6%)                2/48 (4%)                9/48 (19%)      | 
|POLY-3 RATE (b)    |                  8/40.16                  3/38.82                  2/43.43                  9/38.66         | 
|POLY-3 PERCENT (g) |                  19.9%                    7.7%                     4.6%                     23.3%           | 
|TERMINAL (d)       |                  6/29 (21%)               1/23 (4%)                1/32 (3%)                5/25 (20%)      | 
|FIRST INCIDENCE    |                  589                      577                      715                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.231                  P=0.171N                 P=0.035N*                P=0.383         | 
|POLY 3             |                  P=0.270                  P=0.105N                 P=0.032N*                P=0.465         | 
|POLY 1.5           |                  P=0.263                  P=0.099N                 P=0.035N*                P=0.478         | 
|POLY 6             |                  P=0.279                  P=0.117N                 P=0.029N*                P=0.449         | 
|LOGISTIC REGRESSION|                  P=0.243                  P=0.111N                 P=0.031N*                P=0.455         | 
|COCH-ARM / FISHERS |                  P=0.269                  P=0.093N                 P=0.042N*                P=0.519         | 
|ORDER RESTRICTED   |                  P=0.074                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Phthisis Bulbi                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/39.62                  0/38.24                  2/43.58                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      673                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.555                  (e)                      P=0.270                  (e)             | 
|POLY 3             |                  P=0.515                  (e)                      P=0.259                  (e)             | 
|POLY 1.5           |                  P=0.530                  (e)                      P=0.252                  (e)             | 
|POLY 6             |                  P=0.499                  (e)                      P=0.266                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.556                  (e)                      P=0.251                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.565                  (e)                      P=0.253                  (e)             | 
|ORDER RESTRICTED   |                  P=0.268                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral                                                                                                                   | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                1/48 (2%)                2/48 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  1/39.62                  1/38.32                  2/43.43                  2/37.76         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     4.6%                     5.3%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/23 (0%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  728 (T)                  707                      715                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.305                  P=0.723                  P=0.537                  P=0.468         | 
|POLY 3             |                  P=0.313                  P=0.754                  P=0.532                  P=0.483         | 
|POLY 1.5           |                  P=0.316                  P=0.759                  P=0.523                  P=0.490         | 
|POLY 6             |                  P=0.311                  P=0.745                  P=0.541                  P=0.476         | 
|LOGISTIC REGRESSION|                  P=0.315                  P=0.740                  P=0.543                  P=0.504         | 
|COCH-ARM / FISHERS |                  P=0.330                  P=0.747N                 P=0.508                  P=0.508         | 
|ORDER RESTRICTED   |                  P=0.420                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral, Retina                                                                                                           | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/46 (28%)              14/44 (32%)              20/48 (42%)              18/46 (39%)     | 
|POLY-3 RATE (b)    |                  13/39.47                 14/37.26                 20/45.62                 18/37.73        | 
|POLY-3 PERCENT (g) |                  32.9%                    37.6%                    43.8%                    47.7%           | 
|TERMINAL (d)       |                  10/29 (35%)              8/22 (36%)               12/32 (38%)              14/25 (56%)     | 
|FIRST INCIDENCE    |                  626                      598                      508                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.099                  P=0.253                  P=0.202                  P=0.082         | 
|POLY 3             |                  P=0.098                  P=0.426                  P=0.208                  P=0.132         | 
|POLY 1.5           |                  P=0.104                  P=0.437                  P=0.172                  P=0.147         | 
|POLY 6             |                  P=0.090                  P=0.407                  P=0.255                  P=0.111         | 
|LOGISTIC REGRESSION|                  P=0.103                  P=0.378                  P=0.166                  P=0.115         | 
|COCH-ARM / FISHERS |                  P=0.132                  P=0.445                  P=0.126                  P=0.189         | 
|ORDER RESTRICTED   |                  P=0.144                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/46 (46%)              22/44 (50%)              29/48 (60%)              27/46 (59%)     | 
|POLY-3 RATE (b)    |                  21/40.43                 22/38.22                 29/45.96                 27/39.07        | 
|POLY-3 PERCENT (g) |                  51.9%                    57.6%                    63.1%                    69.1%           | 
|TERMINAL (d)       |                  16/29 (55%)              13/22 (59%)              19/32 (59%)              19/25 (76%)     | 
|FIRST INCIDENCE    |                  535                      591                      508                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.073                  P=0.179                  P=0.216                  P=0.048 *       | 
|POLY 3             |                  P=0.060                  P=0.389                  P=0.198                  P=0.080         | 
|POLY 1.5           |                  P=0.066                  P=0.406                  P=0.157                  P=0.096         | 
|POLY 6             |                  P=0.056                  P=0.365                  P=0.252                  P=0.064         | 
|LOGISTIC REGRESSION|                  P=0.066                  P=0.342                  P=0.173                  P=0.076         | 
|COCH-ARM / FISHERS |                  P=0.100                  P=0.420                  P=0.110                  P=0.148         | 
|ORDER RESTRICTED   |                  P=0.081                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  34/47 (72%)              37/48 (77%)              36/48 (75%)              32/48 (67%)     | 
|POLY-3 RATE (b)    |                  34/44.20                 37/44.54                 36/45.93                 32/42.56        | 
|POLY-3 PERCENT (g) |                  76.9%                    83.1%                    78.4%                    75.2%           | 
|TERMINAL (d)       |                  23/29 (79%)              19/23 (83%)              28/32 (88%)              20/25 (80%)     | 
|FIRST INCIDENCE    |                  443                      494                      484                      111             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.405N                 P=0.089                  P=0.453N                 P=0.413         | 
|POLY 3             |                  P=0.345N                 P=0.314                  P=0.537                  P=0.526N        | 
|POLY 1.5           |                  P=0.298N                 P=0.343                  P=0.520                  P=0.460N        | 
|POLY 6             |                  P=0.405N                 P=0.289                  P=0.534                  P=0.599N        | 
|LOGISTIC REGRESSION|                  P=0.306N                 P=0.325                  P=0.589                  P=0.458N        | 
|COCH-ARM / FISHERS |                  P=0.221N                 P=0.384                  P=0.475                  P=0.353N        | 
|ORDER RESTRICTED   |                  P=0.448N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/48 (27%)              22/48 (46%)              19/48 (40%)              14/48 (29%)     | 
|POLY-3 RATE (b)    |                  13/42.79                 22/41.64                 19/44.70                 14/39.34        | 
|POLY-3 PERCENT (g) |                  30.4%                    52.8%                    42.5%                    35.6%           | 
|TERMINAL (d)       |                  8/29 (28%)               11/23 (48%)              16/32 (50%)              9/25 (36%)      | 
|FIRST INCIDENCE    |                  443                      485                      508                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.420N                 P=0.021 *                P=0.235                  P=0.361         | 
|POLY 3             |                  P=0.468N                 P=0.026 *                P=0.167                  P=0.394         | 
|POLY 1.5           |                  P=0.441N                 P=0.032 *                P=0.157                  P=0.424         | 
|POLY 6             |                  P=0.491N                 P=0.020 *                P=0.175                  P=0.367         | 
|LOGISTIC REGRESSION|                  P=0.394N                 P=0.043 *                P=0.136                  P=0.473         | 
|COCH-ARM / FISHERS |                  P=0.359N                 P=0.045 *                P=0.139                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.164                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  33/48 (69%)              31/48 (65%)              30/48 (63%)              30/48 (63%)     | 
|POLY-3 RATE (b)    |                  33/48.00                 31/47.89                 30/47.64                 30/46.78        | 
|POLY-3 PERCENT (g) |                  68.8%                    64.7%                    63.0%                    64.1%           | 
|TERMINAL (d)       |                  14/29 (48%)              9/23 (39%)               15/32 (47%)              9/25 (36%)      | 
|FIRST INCIDENCE    |                  401                      443                      484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.444N                 P=0.441                  P=0.224N                 P=0.526         | 
|POLY 3             |                  P=0.376N                 P=0.421N                 P=0.353N                 P=0.399N        | 
|POLY 1.5           |                  P=0.368N                 P=0.418N                 P=0.345N                 P=0.390N        | 
|POLY 6             |                  P=0.385N                 P=0.426N                 P=0.365N                 P=0.408N        | 
|LOGISTIC REGRESSION|                  P=0.224N                 P=0.158N                 P=0.501N                 P=0.210N        | 
|COCH-ARM / FISHERS |                  P=0.311N                 P=0.414N                 P=0.334N                 P=0.334N        | 
|ORDER RESTRICTED   |                  P=0.471N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  39/48 (81%)              38/48 (79%)              41/48 (85%)              40/48 (83%)     | 
|POLY-3 RATE (b)    |                  39/43.94                 38/43.96                 41/46.27                 40/42.50        | 
|POLY-3 PERCENT (g) |                  88.8%                    86.5%                    88.6%                    94.1%           | 
|TERMINAL (d)       |                  27/29 (93%)              23/23 (100%)             28/32 (88%)              25/25 (100%)    | 
|FIRST INCIDENCE    |                  526                      485                      603                      454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.285                  P=0.175                  P=0.405N                 P=0.163         | 
|POLY 3             |                  P=0.164                  P=0.497N                 P=0.632N                 P=0.267         | 
|POLY 1.5           |                  P=0.192                  P=0.488N                 P=0.539                  P=0.321         | 
|POLY 6             |                  P=0.171                  P=0.542N                 P=0.521N                 P=0.238         | 
|LOGISTIC REGRESSION|                  P=0.168                  P=0.608                  P=0.476N                 P=0.193         | 
|COCH-ARM / FISHERS |                  P=0.355                  P=0.500N                 P=0.392                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.206                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lacrimal Gland                                                                                                                   | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/18 (11%)               2/14 (14%)               2/15 (13%)               3/9 (33%)       | 
|POLY-3 RATE (b)    |                  2/16.29                  2/12.59                  2/13.08                  3/8.31          | 
|POLY-3 PERCENT (g) |                  12.3%                    15.9%                    15.3%                    36.1%           | 
|TERMINAL (d)       |                  1/12 (8%)                2/8 (25%)                2/8 (25%)                3/7 (43%)       | 
|FIRST INCIDENCE    |                  722                      728 (T)                  728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.199                  P=0.556                  P=0.590                  P=0.286         | 
|POLY 3             |                  P=0.135                  P=0.602                  P=0.617                  P=0.193         | 
|POLY 1.5           |                  P=0.137                  P=0.602                  P=0.623                  P=0.191         | 
|POLY 6             |                  P=0.133                  P=0.601                  P=0.603                  P=0.195         | 
|LOGISTIC REGRESSION|                  P=0.148                  P=0.578                  P=0.540                  P=0.213         | 
|COCH-ARM / FISHERS |                  P=0.135                  P=0.597                  P=0.626                  P=0.189         | 
|ORDER RESTRICTED   |                  P=0.152                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lacrimal Gland                                                                                                                   | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/18 (100%)             14/14 (100%)             15/15 (100%)             9/9 (100%)      | 
|POLY-3 RATE (b)    |                  18/18.00                 14/14.00                 15/15.00                 9/9.00          | 
|POLY-3 PERCENT (g) |                  100.0%                   100.0%                   100.0%                   100.0%          | 
|TERMINAL (d)       |                  12/12 (100%)             8/8 (100%)               8/8 (100%)               7/7 (100%)      | 
|FIRST INCIDENCE    |                  626                      574                      603                      630             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 3             |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 1.5           |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 6             |                  (e)                      (e)                      (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  (e)                      (e)                      (e)                      (e)             | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/48 (44%)              17/48 (35%)              20/48 (42%)              15/48 (31%)     | 
|POLY-3 RATE (b)    |                  21/41.30                 17/39.60                 20/44.91                 15/38.70        | 
|POLY-3 PERCENT (g) |                  50.9%                    42.9%                    44.5%                    38.8%           | 
|TERMINAL (d)       |                  19/29 (66%)              14/23 (61%)              16/32 (50%)              10/25 (40%)     | 
|FIRST INCIDENCE    |                  443                      494                      484                      570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.213N                 P=0.590N                 P=0.333N                 P=0.290N        | 
|POLY 3             |                  P=0.199N                 P=0.306N                 P=0.353N                 P=0.187N        | 
|POLY 1.5           |                  P=0.209N                 P=0.284N                 P=0.412N                 P=0.181N        | 
|POLY 6             |                  P=0.172N                 P=0.347N                 P=0.287N                 P=0.185N        | 
|LOGISTIC REGRESSION|                  P=0.217N                 P=0.352N                 P=0.360N                 P=0.220N        | 
|COCH-ARM / FISHERS |                  P=0.182N                 P=0.266N                 P=0.500N                 P=0.146N        | 
|ORDER RESTRICTED   |                  P=0.213N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Clear Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                1/48 (2%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.24                  1/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/23 (9%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.407N                 P=0.188                  P=0.520                  (e)             | 
|POLY 3             |                  P=0.418N                 P=0.226                  P=0.516                  (e)             | 
|POLY 1.5           |                  P=0.413N                 P=0.232                  P=0.510                  (e)             | 
|POLY 6             |                  P=0.425N                 P=0.218                  P=0.522                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      P=0.188                  P=0.520                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.400N                 P=0.247                  P=0.500                  (e)             | 
|ORDER RESTRICTED   |                  P=0.330N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Developmental Malformation                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                7/48 (15%)               2/48 (4%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  4/40.69                  7/38.94                  2/43.66                  5/38.35         | 
|POLY-3 PERCENT (g) |                  9.8%                     18.0%                    4.6%                     13.0%           | 
|TERMINAL (d)       |                  2/29 (7%)                4/23 (17%)               0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  552                      539                      666                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.513N                 P=0.180                  P=0.292N                 P=0.428         | 
|POLY 3             |                  P=0.488N                 P=0.233                  P=0.305N                 P=0.463         | 
|POLY 1.5           |                  P=0.490N                 P=0.246                  P=0.317N                 P=0.471         | 
|POLY 6             |                  P=0.484N                 P=0.213                  P=0.292N                 P=0.454         | 
|LOGISTIC REGRESSION|                  P=0.491N                 P=0.239                  P=0.344N                 P=0.492         | 
|COCH-ARM / FISHERS |                  P=0.478N                 P=0.262                  P=0.339N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.364N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               10/48 (21%)              13/48 (27%)              14/48 (29%)     | 
|POLY-3 RATE (b)    |                  5/40.06                  10/39.98                 13/44.47                 14/38.08        | 
|POLY-3 PERCENT (g) |                  12.5%                    25.0%                    29.2%                    36.8%           | 
|TERMINAL (d)       |                  5/29 (17%)               6/23 (26%)               8/32 (25%)               11/25 (44%)     | 
|FIRST INCIDENCE    |                  728 (T)                  556                      626                      605             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.017 *                P=0.067                  P=0.063                  P=0.007 **      | 
|POLY 3             |                  P=0.013 *                P=0.122                  P=0.051                  P=0.010 *       | 
|POLY 1.5           |                  P=0.014 *                P=0.126                  P=0.042 *                P=0.012 *       | 
|POLY 6             |                  P=0.012 *                P=0.118                  P=0.064                  P=0.009 **      | 
|LOGISTIC REGRESSION|                  P=0.013 *                P=0.110                  P=0.053                  P=0.008 **      | 
|COCH-ARM / FISHERS |                  P=0.022 *                P=0.130                  P=0.033 *                P=0.019 *       | 
|ORDER RESTRICTED   |                  P=0.009 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                3/48 (6%)                4/48 (8%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  2/41.66                  3/38.60                  4/44.32                  5/38.12         | 
|POLY-3 PERCENT (g) |                  4.8%                     7.8%                     9.0%                     13.1%           | 
|TERMINAL (d)       |                  0/29 (0%)                1/23 (4%)                2/32 (6%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  401                      641                      508                      619             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.140                  P=0.458                  P=0.378                  P=0.188         | 
|POLY 3             |                  P=0.131                  P=0.465                  P=0.366                  P=0.180         | 
|POLY 1.5           |                  P=0.135                  P=0.480                  P=0.354                  P=0.189         | 
|POLY 6             |                  P=0.131                  P=0.448                  P=0.380                  P=0.173         | 
|LOGISTIC REGRESSION|                  P=0.193                  P=0.525                  P=0.094                  P=0.277         | 
|COCH-ARM / FISHERS |                  P=0.152                  P=0.500                  P=0.339                  P=0.218         | 
|ORDER RESTRICTED   |                  P=0.148                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/48 (6%)                6/48 (13%)               2/48 (4%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  3/40.06                  6/40.64                  2/43.66                  3/37.18         | 
|POLY-3 PERCENT (g) |                  7.5%                     14.8%                    4.6%                     8.1%            | 
|TERMINAL (d)       |                  3/29 (10%)               2/23 (9%)                1/32 (3%)                3/25 (12%)      | 
|FIRST INCIDENCE    |                  728 (T)                  485                      652                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.354N                 P=0.188                  P=0.442N                 P=0.594         | 
|POLY 3             |                  P=0.353N                 P=0.247                  P=0.461N                 P=0.628         | 
|POLY 1.5           |                  P=0.351N                 P=0.246                  P=0.476N                 P=0.638         | 
|POLY 6             |                  P=0.354N                 P=0.245                  P=0.444N                 P=0.617         | 
|LOGISTIC REGRESSION|                  P=0.328N                 P=0.258                  P=0.452N                 P=0.594         | 
|COCH-ARM / FISHERS |                  P=0.336N                 P=0.243                  P=0.500N                 P=0.661N        | 
|ORDER RESTRICTED   |                  P=0.356N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                3/48 (6%)                3/48 (6%)                8/48 (17%)      | 
|POLY-3 RATE (b)    |                  2/40.48                  3/38.68                  3/43.37                  8/38.61         | 
|POLY-3 PERCENT (g) |                  4.9%                     7.8%                     6.9%                     20.7%           | 
|TERMINAL (d)       |                  1/29 (3%)                2/23 (9%)                3/32 (9%)                5/25 (20%)      | 
|FIRST INCIDENCE    |                  606                      598                      728 (T)                  443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.014 *                P=0.419                  P=0.546                  P=0.033 *       | 
|POLY 3             |                  P=0.015 *                P=0.479                  P=0.531                  P=0.035 *       | 
|POLY 1.5           |                  P=0.015 *                P=0.489                  P=0.520                  P=0.038 *       | 
|POLY 6             |                  P=0.015 *                P=0.464                  P=0.542                  P=0.033 *       | 
|LOGISTIC REGRESSION|                  P=0.015 *                P=0.495                  P=0.532                  P=0.044 *       | 
|COCH-ARM / FISHERS |                  P=0.018 *                P=0.500                  P=0.500                  P=0.045 *       | 
|ORDER RESTRICTED   |                  P=0.012 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                2/48 (4%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  2/38.24                  0/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     5.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                2/23 (9%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.155N                 P=0.419                  P=0.480N                 P=0.530N        | 
|POLY 3             |                  P=0.154N                 P=0.484                  P=0.484N                 P=0.515N        | 
|POLY 1.5           |                  P=0.155N                 P=0.492                  P=0.490N                 P=0.511N        | 
|POLY 6             |                  P=0.153N                 P=0.472                  P=0.478N                 P=0.520N        | 
|LOGISTIC REGRESSION|                  P=0.155N                 P=0.419                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.155N                 P=0.500                  P=0.500N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.172N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Focal Granulomatous                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/48 (38%)              15/48 (31%)              23/48 (48%)              19/48 (40%)     | 
|POLY-3 RATE (b)    |                  18/40.40                 15/39.44                 23/44.82                 19/38.83        | 
|POLY-3 PERCENT (g) |                  44.6%                    38.0%                    51.3%                    48.9%           | 
|TERMINAL (d)       |                  17/29 (59%)              13/23 (57%)              19/32 (59%)              14/25 (56%)     | 
|FIRST INCIDENCE    |                  631                      512                      484                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.206                  P=0.547                  P=0.335                  P=0.279         | 
|POLY 3             |                  P=0.239                  P=0.354N                 P=0.339                  P=0.432         | 
|POLY 1.5           |                  P=0.237                  P=0.341N                 P=0.280                  P=0.444         | 
|POLY 6             |                  P=0.255                  P=0.384N                 P=0.411                  P=0.426         | 
|LOGISTIC REGRESSION|                  P=0.205                  P=0.455N                 P=0.363                  P=0.334         | 
|COCH-ARM / FISHERS |                  P=0.281                  P=0.334N                 P=0.205                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.334                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                0/48 (0%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.32                  0/43.37                  1/37.29         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/23 (4%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      708                      ---                      699             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.576                  P=0.200                  (e)                      P=0.459         | 
|POLY 3             |                  P=0.583                  P=0.227                  (e)                      P=0.486         | 
|POLY 1.5           |                  P=0.587                  P=0.232                  (e)                      P=0.490         | 
|POLY 6             |                  P=0.577                  P=0.219                  (e)                      P=0.481         | 
|LOGISTIC REGRESSION|                  P=0.590                  P=0.212                  (e)                      P=0.484         | 
|COCH-ARM / FISHERS |                  P=0.600                  P=0.247                  (e)                      P=0.500         | 
|ORDER RESTRICTED   |                  P=0.311                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                2/48 (4%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.24                  2/43.81                  1/37.45         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     4.6%                     2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                2/23 (9%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  603                      654             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.493                  P=0.188                  P=0.266                  P=0.488         | 
|POLY 3             |                  P=0.466                  P=0.226                  P=0.257                  P=0.487         | 
|POLY 1.5           |                  P=0.474                  P=0.232                  P=0.249                  P=0.490         | 
|POLY 6             |                  P=0.459                  P=0.218                  P=0.266                  P=0.483         | 
|LOGISTIC REGRESSION|                  P=0.490                  P=0.188                  P=0.208                  P=0.504         | 
|COCH-ARM / FISHERS |                  P=0.500                  P=0.247                  P=0.247                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.237                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                4/48 (8%)                1/48 (2%)                6/48 (13%)      | 
|POLY-3 RATE (b)    |                  4/41.39                  4/38.98                  1/43.63                  6/38.64         | 
|POLY-3 PERCENT (g) |                  9.7%                     10.3%                    2.3%                     15.5%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                0/32 (0%)                4/25 (16%)      | 
|FIRST INCIDENCE    |                  529                      613                      659                      111             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.301                  P=0.549                  P=0.152N                 P=0.306         | 
|POLY 3             |                  P=0.312                  P=0.611                  P=0.162N                 P=0.325         | 
|POLY 1.5           |                  P=0.313                  P=0.626                  P=0.168N                 P=0.343         | 
|POLY 6             |                  P=0.309                  P=0.589                  P=0.157N                 P=0.303         | 
|LOGISTIC REGRESSION|                  P=0.392                  P=0.631N                 P=0.257N                 P=0.451         | 
|COCH-ARM / FISHERS |                  P=0.319                  P=0.643N                 P=0.181N                 P=0.370         | 
|ORDER RESTRICTED   |                  P=0.156                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/48 (21%)              10/48 (21%)              9/48 (19%)               5/48 (10%)      | 
|POLY-3 RATE (b)    |                  10/40.44                 10/38.87                 9/44.04                  5/37.29         | 
|POLY-3 PERCENT (g) |                  24.7%                    25.7%                    20.4%                    13.4%           | 
|TERMINAL (d)       |                  8/29 (28%)               8/23 (35%)               7/32 (22%)               4/25 (16%)      | 
|FIRST INCIDENCE    |                  641                      539                      603                      699             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.097N                 P=0.394                  P=0.398N                 P=0.211N        | 
|POLY 3             |                  P=0.101N                 P=0.562                  P=0.417N                 P=0.163N        | 
|POLY 1.5           |                  P=0.100N                 P=0.581                  P=0.449N                 P=0.153N        | 
|POLY 6             |                  P=0.101N                 P=0.529                  P=0.383N                 P=0.176N        | 
|LOGISTIC REGRESSION|                  P=0.095N                 P=0.508                  P=0.396N                 P=0.185N        | 
|COCH-ARM / FISHERS |                  P=0.087N                 P=0.599N                 P=0.500N                 P=0.130N        | 
|ORDER RESTRICTED   |                  P=0.160N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/48 (0%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  0/43.37                  4/38.99         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     10.3%           | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      378             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.002 **               (e)                      (e)                      P=0.056         | 
|POLY 3             |                  P=0.002 **               (e)                      (e)                      P=0.056         | 
|POLY 1.5           |                  P=0.002 **               (e)                      (e)                      P=0.057         | 
|POLY 6             |                  P=0.003 **               (e)                      (e)                      P=0.055         | 
|LOGISTIC REGRESSION|                  P=0.007 **               (e)                      (e)                      P=0.088         | 
|COCH-ARM / FISHERS |                  P=0.003 **               (e)                      (e)                      P=0.059         | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                1/48 (2%)                4/48 (8%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  1/43.37                  4/38.16         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     10.5%           | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.004 **               (e)                      P=0.520                  P=0.054         | 
|POLY 3             |                  P=0.004 **               (e)                      P=0.516                  P=0.053         | 
|POLY 1.5           |                  P=0.004 **               (e)                      P=0.510                  P=0.055         | 
|POLY 6             |                  P=0.004 **               (e)                      P=0.522                  P=0.051         | 
|LOGISTIC REGRESSION|                  P=0.005 **               (e)                      P=0.520                  P=0.065         | 
|COCH-ARM / FISHERS |                  P=0.005 **               (e)                      P=0.500                  P=0.059         | 
|ORDER RESTRICTED   |                  P=0.005 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  0/43.37                  2/38.17         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      111             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.042 *                (e)                      (e)                      P=0.223         | 
|POLY 3             |                  P=0.043 *                (e)                      (e)                      P=0.226         | 
|POLY 1.5           |                  P=0.043 *                (e)                      (e)                      P=0.230         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.221         | 
|LOGISTIC REGRESSION|                  P=0.154                  (e)                      (e)                      P=0.423         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.025 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                3/48 (6%)                4/48 (8%)                8/48 (17%)      | 
|POLY-3 RATE (b)    |                  1/40.06                  3/38.79                  4/43.37                  8/38.16         | 
|POLY-3 PERCENT (g) |                  2.5%                     7.7%                     9.2%                     21.0%           | 
|TERMINAL (d)       |                  1/29 (3%)                2/23 (9%)                4/32 (13%)               6/25 (24%)      | 
|FIRST INCIDENCE    |                  728 (T)                  556                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.005 **               P=0.248                  P=0.208                  P=0.011 *       | 
|POLY 3             |                  P=0.005 **               P=0.293                  P=0.203                  P=0.011 *       | 
|POLY 1.5           |                  P=0.006 **               P=0.299                  P=0.194                  P=0.013 *       | 
|POLY 6             |                  P=0.005 **               P=0.283                  P=0.213                  P=0.010 *       | 
|LOGISTIC REGRESSION|                  P=0.005 **               P=0.295                  P=0.208                  P=0.013 *       | 
|COCH-ARM / FISHERS |                  P=0.007 **               P=0.308                  P=0.181                  P=0.015 *       | 
|ORDER RESTRICTED   |                  P=0.004 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  1/38.40                  2/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     2.6%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/23 (0%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  686                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.382N                 P=0.727                  P=0.535                  P=0.530N        | 
|POLY 3             |                  P=0.390N                 P=0.752                  P=0.528                  P=0.515N        | 
|POLY 1.5           |                  P=0.386N                 P=0.756                  P=0.517                  P=0.511N        | 
|POLY 6             |                  P=0.393N                 P=0.745                  P=0.539                  P=0.520N        | 
|LOGISTIC REGRESSION|                  P=0.382N                 P=0.746                  P=0.535                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.370N                 P=0.753N                 P=0.500                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.292N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/46 (0%)                2/47 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/39.12                  0/37.27                  2/42.58                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.7%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/31 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      673                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.554                  (e)                      P=0.266                  (e)             | 
|POLY 3             |                  P=0.520                  (e)                      P=0.256                  (e)             | 
|POLY 1.5           |                  P=0.534                  (e)                      P=0.249                  (e)             | 
|POLY 6             |                  P=0.504                  (e)                      P=0.264                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.559                  (e)                      P=0.249                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.568                  (e)                      P=0.247                  (e)             | 
|ORDER RESTRICTED   |                  P=0.265                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                3/46 (7%)                2/47 (4%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  1/39.12                  3/37.48                  2/42.37                  5/39.70         | 
|POLY-3 PERCENT (g) |                  2.6%                     8.0%                     4.7%                     12.6%           | 
|TERMINAL (d)       |                  1/29 (3%)                1/23 (4%)                2/31 (7%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  728 (T)                  687                      728 (T)                  111             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.081                  P=0.248                  P=0.523                  P=0.095         | 
|POLY 3             |                  P=0.096                  P=0.289                  P=0.528                  P=0.103         | 
|POLY 1.5           |                  P=0.095                  P=0.293                  P=0.517                  P=0.103         | 
|POLY 6             |                  P=0.098                  P=0.282                  P=0.538                  P=0.103         | 
|LOGISTIC REGRESSION|                  P=0.138                  P=0.273                  P=0.523                  P=0.180         | 
|COCH-ARM / FISHERS |                  P=0.095                  P=0.300                  P=0.500                  P=0.107         | 
|ORDER RESTRICTED   |                  P=0.058                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/47 (11%)               5/46 (11%)               5/47 (11%)               7/48 (15%)      | 
|POLY-3 RATE (b)    |                  5/39.82                  5/37.59                  5/42.67                  7/39.17         | 
|POLY-3 PERCENT (g) |                  12.6%                    13.3%                    11.7%                    17.9%           | 
|TERMINAL (d)       |                  2/29 (7%)                4/23 (17%)               2/31 (7%)                3/25 (12%)      | 
|FIRST INCIDENCE    |                  631                      641                      692                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.267                  P=0.501                  P=0.565N                 P=0.308         | 
|POLY 3             |                  P=0.305                  P=0.595                  P=0.587N                 P=0.365         | 
|POLY 1.5           |                  P=0.304                  P=0.606                  P=0.603N                 P=0.372         | 
|POLY 6             |                  P=0.307                  P=0.576                  P=0.572N                 P=0.356         | 
|LOGISTIC REGRESSION|                  P=0.302                  P=0.597                  P=0.592N                 P=0.408         | 
|COCH-ARM / FISHERS |                  P=0.314                  P=0.616                  P=0.630N                 P=0.395         | 
|ORDER RESTRICTED   |                  P=0.390                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                0/47 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/39.37                  0/38.01                  0/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  5.1%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/28 (4%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  641                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.138N                 P=0.275N                 P=0.209N                 P=0.269N        | 
|POLY 3             |                  P=0.124N                 P=0.244N                 P=0.216N                 P=0.250N        | 
|POLY 1.5           |                  P=0.129N                 P=0.240N                 P=0.222N                 P=0.245N        | 
|POLY 6             |                  P=0.117N                 P=0.252N                 P=0.210N                 P=0.256N        | 
|LOGISTIC REGRESSION|                  P=0.136N                 P=0.240N                 P=0.232N                 P=0.243N        | 
|COCH-ARM / FISHERS |                  P=0.136N                 P=0.247N                 P=0.242N                 P=0.242N        | 
|ORDER RESTRICTED   |                  P=0.034N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/10 (0%)                0/7 (0%)                 0/7 (0%)                 2/5 (40%)       | 
|POLY-3 RATE (b)    |                  0/8.22                   0/5.22                   0/6.13                   2/4.15          | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     48.2%           | 
|TERMINAL (d)       |                  0/4 (0%)                 0/2 (0%)                 0/4 (0%)                 1/2 (50%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      694             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.027 *                (e)                      (e)                      P=0.150         | 
|POLY 3             |                  P=0.005 **               (e)                      (e)                      P=0.060         | 
|POLY 1.5           |                  P=0.005 **               (e)                      (e)                      P=0.062         | 
|POLY 6             |                  P=0.005 **               (e)                      (e)                      P=0.058         | 
|LOGISTIC REGRESSION|                  P=0.012 *                (e)                      (e)                      P=0.075         | 
|COCH-ARM / FISHERS |                  P=0.013 *                (e)                      (e)                      P=0.095         | 
|ORDER RESTRICTED   |                  P=0.003 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/10 (20%)               0/7 (0%)                 0/7 (0%)                 1/5 (20%)       | 
|POLY-3 RATE (b)    |                  2/8.29                   0/5.22                   0/6.13                   1/4.01          | 
|POLY-3 PERCENT (g) |                  24.1%                    0.0%                     0.0%                     24.9%           | 
|TERMINAL (d)       |                  1/4 (25%)                0/2 (0%)                 0/4 (0%)                 1/2 (50%)       | 
|FIRST INCIDENCE    |                  711                      ---                      ---                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.585N                 P=0.336N                 P=0.230N                 P=0.691N        | 
|POLY 3             |                  P=0.636N                 P=0.336N                 P=0.294N                 P=0.739         | 
|POLY 1.5           |                  P=0.647N                 P=0.328N                 P=0.302N                 P=0.739         | 
|POLY 6             |                  P=0.621N                 P=0.345N                 P=0.283N                 P=0.737         | 
|LOGISTIC REGRESSION|                  P=0.674N                 P=0.340N                 P=0.265N                 P=0.739         | 
|COCH-ARM / FISHERS |                  P=0.665N                 P=0.331N                 P=0.331N                 P=0.736         | 
|ORDER RESTRICTED   |                  P=0.342N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/10 (10%)               1/7 (14%)                3/7 (43%)                0/5 (0%)        | 
|POLY-3 RATE (b)    |                  1/8.22                   1/5.60                   3/6.56                   0/4.01          | 
|POLY-3 PERCENT (g) |                  12.2%                    17.9%                    45.7%                    0.0%            | 
|TERMINAL (d)       |                  1/4 (25%)                0/2 (0%)                 2/4 (50%)                0/2 (0%)        | 
|FIRST INCIDENCE    |                  728 (T)                  624                      603                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.505N                 P=0.665                  P=0.300                  P=0.638N        | 
|POLY 3             |                  P=0.614                  P=0.677                  P=0.190                  P=0.642N        | 
|POLY 1.5           |                  P=0.626                  P=0.675                  P=0.174                  P=0.639N        | 
|POLY 6             |                  P=0.592                  P=0.686                  P=0.216                  P=0.646N        | 
|LOGISTIC REGRESSION|                  P=0.629N                 P=0.679                  P=0.176                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.634N                 P=0.669                  P=0.162                  P=0.667N        | 
|ORDER RESTRICTED   |                  P=0.292N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/10 (20%)               0/7 (0%)                 0/7 (0%)                 0/5 (0%)        | 
|POLY-3 RATE (b)    |                  2/8.64                   0/5.22                   0/6.13                   0/4.01          | 
|POLY-3 PERCENT (g) |                  23.1%                    0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/4 (25%)                0/2 (0%)                 0/4 (0%)                 0/2 (0%)        | 
|FIRST INCIDENCE    |                  606                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.153N                 P=0.339N                 P=0.227N                 P=0.327N        | 
|POLY 3             |                  P=0.174N                 P=0.349N                 P=0.306N                 P=0.415N        | 
|POLY 1.5           |                  P=0.183N                 P=0.334N                 P=0.308N                 P=0.407N        | 
|POLY 6             |                  P=0.162N                 P=0.365N                 P=0.303N                 P=0.430N        | 
|LOGISTIC REGRESSION|                  P=0.198N                 P=0.311N                 P=0.327N                 P=0.391N        | 
|COCH-ARM / FISHERS |                  P=0.197N                 P=0.331N                 P=0.331N                 P=0.429N        | 
|ORDER RESTRICTED   |                  P=0.158N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/10 (20%)               0/7 (0%)                 1/7 (14%)                0/5 (0%)        | 
|POLY-3 RATE (b)    |                  2/8.24                   0/5.22                   1/6.13                   0/4.01          | 
|POLY-3 PERCENT (g) |                  24.3%                    0.0%                     16.3%                    0.0%            | 
|TERMINAL (d)       |                  1/4 (25%)                0/2 (0%)                 1/4 (25%)                0/2 (0%)        | 
|FIRST INCIDENCE    |                  722                      ---                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.265N                 P=0.348N                 P=0.492N                 P=0.337N        | 
|POLY 3             |                  P=0.319N                 P=0.335N                 P=0.610N                 P=0.402N        | 
|POLY 1.5           |                  P=0.327N                 P=0.327N                 P=0.617N                 P=0.399N        | 
|POLY 6             |                  P=0.311N                 P=0.341N                 P=0.598N                 P=0.406N        | 
|LOGISTIC REGRESSION|                  P=0.319N                 P=0.353N                 P=0.555N                 P=0.434N        | 
|COCH-ARM / FISHERS |                  P=0.335N                 P=0.331N                 P=0.640N                 P=0.429N        | 
|ORDER RESTRICTED   |                  P=0.224N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Galactocele                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/46 (9%)                8/48 (17%)               2/48 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  4/38.49                  8/39.99                  2/43.65                  2/37.52         | 
|POLY-3 PERCENT (g) |                  10.4%                    20.0%                    4.6%                     5.3%            | 
|TERMINAL (d)       |                  2/27 (7%)                4/23 (17%)               0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  626                      485                      666                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.085N                 P=0.130                  P=0.282N                 P=0.392N        | 
|POLY 3             |                  P=0.073N                 P=0.191                  P=0.280N                 P=0.348N        | 
|POLY 1.5           |                  P=0.073N                 P=0.196                  P=0.295N                 P=0.340N        | 
|POLY 6             |                  P=0.072N                 P=0.181                  P=0.266N                 P=0.357N        | 
|LOGISTIC REGRESSION|                  P=0.070N                 P=0.197                  P=0.294N                 P=0.344N        | 
|COCH-ARM / FISHERS |                  P=0.070N                 P=0.199                  P=0.318N                 P=0.318N        | 
|ORDER RESTRICTED   |                  P=0.104N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  28/46 (61%)              33/48 (69%)              29/48 (60%)              35/48 (73%)     | 
|POLY-3 RATE (b)    |                  28/42.54                 33/43.96                 29/46.60                 35/42.66        | 
|POLY-3 PERCENT (g) |                  65.8%                    75.1%                    62.2%                    82.1%           | 
|TERMINAL (d)       |                  15/27 (56%)              16/23 (70%)              16/32 (50%)              19/25 (76%)     | 
|FIRST INCIDENCE    |                  526                      443                      603                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.201                  P=0.110                  P=0.352N                 P=0.084         | 
|POLY 3             |                  P=0.122                  P=0.232                  P=0.448N                 P=0.064         | 
|POLY 1.5           |                  P=0.127                  P=0.257                  P=0.491N                 P=0.076         | 
|POLY 6             |                  P=0.132                  P=0.193                  P=0.410N                 P=0.061         | 
|LOGISTIC REGRESSION|                  P=0.146                  P=0.254                  P=0.533N                 P=0.082         | 
|COCH-ARM / FISHERS |                  P=0.198                  P=0.280                  P=0.566N                 P=0.153         | 
|ORDER RESTRICTED   |                  P=0.067                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland: Duct                                                                                                              | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/46 (26%)              22/48 (46%)              18/48 (38%)              11/48 (23%)     | 
|POLY-3 RATE (b)    |                  12/40.03                 22/41.36                 18/45.47                 11/38.63        | 
|POLY-3 PERCENT (g) |                  30.0%                    53.2%                    39.6%                    28.5%           | 
|TERMINAL (d)       |                  6/27 (22%)               12/23 (52%)              9/32 (28%)               5/25 (20%)      | 
|FIRST INCIDENCE    |                  443                      485                      619                      589             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.212N                 P=0.016 *                P=0.300                  P=0.572         | 
|POLY 3             |                  P=0.195N                 P=0.024 *                P=0.241                  P=0.541N        | 
|POLY 1.5           |                  P=0.186N                 P=0.029 *                P=0.208                  P=0.517N        | 
|POLY 6             |                  P=0.196N                 P=0.019 *                P=0.287                  P=0.561N        | 
|LOGISTIC REGRESSION|                  P=0.166N                 P=0.032 *                P=0.170                  P=0.503N        | 
|COCH-ARM / FISHERS |                  P=0.146N                 P=0.037 *                P=0.167                  P=0.453N        | 
|ORDER RESTRICTED   |                  P=0.172N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/9 (78%)                4/5 (80%)                2/2 (100%)               3/4 (75%)       | 
|POLY-3 RATE (b)    |                  7/8.03                   4/4.60                   2/2.00                   3/3.53          | 
|POLY-3 PERCENT (g) |                  87.2%                    87.0%                    100.0%                   85.0%           | 
|TERMINAL (d)       |                  6/6 (100%)               1/1 (100%)               0/0 (0%)                 2/2 (100%)      | 
|FIRST INCIDENCE    |                  704                      512                      484                      630             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.456N                 P=0.276                  P=0.520                  P=0.733         | 
|POLY 3             |                  P=0.692                  P=0.846N                 P=0.831                  P=0.839N        | 
|POLY 1.5           |                  P=0.659                  P=0.780                  P=0.714                  P=0.769N        | 
|POLY 6             |                  P=0.778                  P=0.945N                 P=0.981                  P=0.961N        | 
|LOGISTIC REGRESSION|                  P=0.605                  P=0.363                  P=0.231                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.642                  P=0.769N                 P=0.655                  P=0.706N        | 
|ORDER RESTRICTED   |                  P=0.639N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                1/48 (2%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  1/43.37                  2/38.16         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     5.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.059                  (e)                      P=0.520                  P=0.228         | 
|POLY 3             |                  P=0.061                  (e)                      P=0.516                  P=0.226         | 
|POLY 1.5           |                  P=0.061                  (e)                      P=0.510                  P=0.228         | 
|POLY 6             |                  P=0.061                  (e)                      P=0.522                  P=0.223         | 
|LOGISTIC REGRESSION|                  P=0.084                  (e)                      P=0.520                  P=0.294         | 
|COCH-ARM / FISHERS |                  P=0.064                  (e)                      P=0.500                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.067                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                1/48 (2%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  1/43.37                  2/38.16         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     5.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.059                  (e)                      P=0.520                  P=0.228         | 
|POLY 3             |                  P=0.061                  (e)                      P=0.516                  P=0.226         | 
|POLY 1.5           |                  P=0.061                  (e)                      P=0.510                  P=0.228         | 
|POLY 6             |                  P=0.061                  (e)                      P=0.522                  P=0.223         | 
|LOGISTIC REGRESSION|                  P=0.084                  (e)                      P=0.520                  P=0.294         | 
|COCH-ARM / FISHERS |                  P=0.064                  (e)                      P=0.500                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.067                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  19/48 (40%)              10/48 (21%)              11/48 (23%)              13/48 (27%)     | 
|POLY-3 RATE (b)    |                  19/42.93                 10/39.71                 11/43.63                 13/39.70        | 
|POLY-3 PERCENT (g) |                  44.3%                    25.2%                    25.2%                    32.7%           | 
|TERMINAL (d)       |                  10/29 (35%)              6/23 (26%)               10/32 (31%)              6/25 (24%)      | 
|FIRST INCIDENCE    |                  535                      485                      659                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.291N                 P=0.134N                 P=0.039N*                P=0.285N        | 
|POLY 3             |                  P=0.251N                 P=0.052N                 P=0.047N*                P=0.195N        | 
|POLY 1.5           |                  P=0.256N                 P=0.042N*                P=0.050N                 P=0.178N        | 
|POLY 6             |                  P=0.243N                 P=0.073N                 P=0.049N*                P=0.218N        | 
|LOGISTIC REGRESSION|                  P=0.269N                 P=0.043N*                P=0.043N*                P=0.169N        | 
|COCH-ARM / FISHERS |                  P=0.241N                 P=0.037N*                P=0.061N                 P=0.139N        | 
|ORDER RESTRICTED   |                  P=0.075N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Olfactory Epithelium                                                                                                       | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                3/48 (6%)                6/48 (13%)               1/48 (2%)       | 
|POLY-3 RATE (b)    |                  2/40.06                  3/38.24                  6/43.37                  1/37.18         | 
|POLY-3 PERCENT (g) |                  5.0%                     7.9%                     13.8%                    2.7%            | 
|TERMINAL (d)       |                  2/29 (7%)                3/23 (13%)               6/32 (19%)               1/25 (4%)       | 
|FIRST INCIDENCE    |                  728 (T)                  728 (T)                  728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.440N                 P=0.393                  P=0.163                  P=0.552N        | 
|POLY 3             |                  P=0.466N                 P=0.479                  P=0.159                  P=0.526N        | 
|POLY 1.5           |                  P=0.456N                 P=0.489                  P=0.149                  P=0.519N        | 
|POLY 6             |                  P=0.475N                 P=0.463                  P=0.169                  P=0.535N        | 
|LOGISTIC REGRESSION|                  P=0.440N                 P=0.393                  P=0.163                  P=0.552N        | 
|COCH-ARM / FISHERS |                  P=0.423N                 P=0.500                  P=0.134                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.235N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Olfactory Epithelium, Respiratory Epithelium                                                                               | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/40.06                  0/38.24                  2/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  1/29 (3%)                0/23 (0%)                2/32 (6%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  728 (T)                  ---                      728 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.510N                 P=0.546N                 P=0.535                  P=0.530N        | 
|POLY 3             |                  P=0.515N                 P=0.509N                 P=0.528                  P=0.515N        | 
|POLY 1.5           |                  P=0.513N                 P=0.505N                 P=0.517                  P=0.511N        | 
|POLY 6             |                  P=0.516N                 P=0.516N                 P=0.539                  P=0.520N        | 
|LOGISTIC REGRESSION|                  P=0.510N                 (e)                      P=0.535                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.500N                 P=0.500N                 P=0.500                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.339N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  18/48 (38%)              14/48 (29%)              11/47 (23%)              10/48 (21%)     | 
|POLY-3 RATE (b)    |                  18/42.33                 14/41.35                 11/43.73                 10/37.74        | 
|POLY-3 PERCENT (g) |                  42.5%                    33.9%                    25.2%                    26.5%           | 
|TERMINAL (d)       |                  10/29 (35%)              6/23 (26%)               6/32 (19%)               8/25 (32%)      | 
|FIRST INCIDENCE    |                  533                      539                      627                      634             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.069N                 P=0.474N                 P=0.063N                 P=0.141N        | 
|POLY 3             |                  P=0.067N                 P=0.275N                 P=0.067N                 P=0.098N        | 
|POLY 1.5           |                  P=0.061N                 P=0.265N                 P=0.078N                 P=0.081N        | 
|POLY 6             |                  P=0.076N                 P=0.296N                 P=0.058N                 P=0.128N        | 
|LOGISTIC REGRESSION|                  P=0.054N                 P=0.272N                 P=0.081N                 P=0.086N        | 
|COCH-ARM / FISHERS |                  P=0.047N*                P=0.258N                 P=0.102N                 P=0.058N        | 
|ORDER RESTRICTED   |                  P=0.083N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               4/48 (8%)                7/47 (15%)               11/48 (23%)     | 
|POLY-3 RATE (b)    |                  5/40.75                  4/38.65                  7/43.60                  11/38.56        | 
|POLY-3 PERCENT (g) |                  12.3%                    10.4%                    16.1%                    28.5%           | 
|TERMINAL (d)       |                  2/29 (7%)                3/23 (13%)               5/32 (16%)               8/25 (32%)      | 
|FIRST INCIDENCE    |                  626                      610                      484                      508             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.018 *                P=0.614N                 P=0.455                  P=0.053         | 
|POLY 3             |                  P=0.019 *                P=0.533N                 P=0.427                  P=0.061         | 
|POLY 1.5           |                  P=0.019 *                P=0.517N                 P=0.403                  P=0.067         | 
|POLY 6             |                  P=0.019 *                P=0.560N                 P=0.450                  P=0.054         | 
|LOGISTIC REGRESSION|                  P=0.018 *                P=0.528N                 P=0.356                  P=0.065         | 
|COCH-ARM / FISHERS |                  P=0.023 *                P=0.500N                 P=0.364                  P=0.085         | 
|ORDER RESTRICTED   |                  P=0.027 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                1/48 (2%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  1/43.37                  2/37.70         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     5.3%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.059                  (e)                      P=0.520                  P=0.221         | 
|POLY 3             |                  P=0.060                  (e)                      P=0.516                  P=0.223         | 
|POLY 1.5           |                  P=0.060                  (e)                      P=0.510                  P=0.227         | 
|POLY 6             |                  P=0.060                  (e)                      P=0.522                  P=0.220         | 
|LOGISTIC REGRESSION|                  P=0.062                  (e)                      P=0.520                  P=0.242         | 
|COCH-ARM / FISHERS |                  P=0.064                  (e)                      P=0.500                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.066                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/48 (27%)              14/48 (29%)              12/48 (25%)              7/48 (15%)      | 
|POLY-3 RATE (b)    |                  13/42.71                 14/40.14                 12/44.51                 7/38.16         | 
|POLY-3 PERCENT (g) |                  30.4%                    34.9%                    27.0%                    18.3%           | 
|TERMINAL (d)       |                  6/29 (21%)               7/23 (30%)               8/32 (25%)               4/25 (16%)      | 
|FIRST INCIDENCE    |                  529                      577                      508                      562             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.080N                 P=0.330                  P=0.388N                 P=0.187N        | 
|POLY 3             |                  P=0.081N                 P=0.422                  P=0.451N                 P=0.157N        | 
|POLY 1.5           |                  P=0.074N                 P=0.458                  P=0.467N                 P=0.137N        | 
|POLY 6             |                  P=0.092N                 P=0.373                  P=0.443N                 P=0.185N        | 
|LOGISTIC REGRESSION|                  P=0.063N                 P=0.484                  P=0.530N                 P=0.116N        | 
|COCH-ARM / FISHERS |                  P=0.056N                 P=0.500                  P=0.500N                 P=0.104N        | 
|ORDER RESTRICTED   |                  P=0.118N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               2/47 (4%)                2/46 (4%)                2/45 (4%)       | 
|POLY-3 RATE (b)    |                  5/40.75                  2/38.76                  2/42.41                  2/35.73         | 
|POLY-3 PERCENT (g) |                  12.3%                    5.2%                     4.7%                     5.6%            | 
|TERMINAL (d)       |                  3/29 (10%)               0/23 (0%)                1/32 (3%)                2/25 (8%)       | 
|FIRST INCIDENCE    |                  535                      540                      673                      728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.225N                 P=0.275N                 P=0.184N                 P=0.280N        | 
|POLY 3             |                  P=0.232N                 P=0.235N                 P=0.199N                 P=0.271N        | 
|POLY 1.5           |                  P=0.235N                 P=0.229N                 P=0.212N                 P=0.264N        | 
|POLY 6             |                  P=0.226N                 P=0.246N                 P=0.186N                 P=0.280N        | 
|LOGISTIC REGRESSION|                  P=0.233N                 P=0.222N                 P=0.230N                 P=0.262N        | 
|COCH-ARM / FISHERS |                  P=0.231N                 P=0.226N                 P=0.235N                 P=0.245N        | 
|ORDER RESTRICTED   |                  P=0.178N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/48 (17%)               5/47 (11%)               9/46 (20%)               9/45 (20%)      | 
|POLY-3 RATE (b)    |                  8/41.50                  5/38.72                  9/42.92                  9/38.48         | 
|POLY-3 PERCENT (g) |                  19.3%                    12.9%                    21.0%                    23.4%           | 
|TERMINAL (d)       |                  5/29 (17%)               2/23 (9%)                7/32 (22%)               3/25 (12%)      | 
|FIRST INCIDENCE    |                  443                      591                      508                      443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.245                  P=0.394N                 P=0.583                  P=0.397         | 
|POLY 3             |                  P=0.241                  P=0.319N                 P=0.531                  P=0.431         | 
|POLY 1.5           |                  P=0.227                  P=0.305N                 P=0.505                  P=0.425         | 
|POLY 6             |                  P=0.263                  P=0.342N                 P=0.555                  P=0.440         | 
|LOGISTIC REGRESSION|                  P=0.235                  P=0.291N                 P=0.442                  P=0.471         | 
|COCH-ARM / FISHERS |                  P=0.227                  P=0.290N                 P=0.461                  P=0.441         | 
|ORDER RESTRICTED   |                  P=0.330                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               0/47 (0%)                11/46 (24%)              6/45 (13%)      | 
|POLY-3 RATE (b)    |                  5/40.37                  0/38.01                  11/43.23                 6/37.98         | 
|POLY-3 PERCENT (g) |                  12.4%                    0.0%                     25.5%                    15.8%           | 
|TERMINAL (d)       |                  4/29 (14%)               0/23 (0%)                9/32 (28%)               2/25 (8%)       | 
|FIRST INCIDENCE    |                  641                      ---                      508                      443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.094                  P=0.054N                 P=0.125                  P=0.417         | 
|POLY 3             |                  P=0.089                  P=0.035N*                P=0.106                  P=0.457         | 
|POLY 1.5           |                  P=0.080                  P=0.033N*                P=0.091                  P=0.449         | 
|POLY 6             |                  P=0.105                  P=0.038N*                P=0.123                  P=0.466         | 
|LOGISTIC REGRESSION|                  P=0.086                  P=0.040N*                P=0.092                  P=0.472         | 
|COCH-ARM / FISHERS |                  P=0.087                  P=0.030N*                P=0.071                  P=0.454         | 
|ORDER RESTRICTED   |                  P=0.040 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/47 (4%)                1/48 (2%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.29                  1/43.37                  1/37.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     2.3%                     2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      648                      728 (T)                  589             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.534                  P=0.226                  P=0.520                  P=0.485         | 
|POLY 3             |                  P=0.522                  P=0.227                  P=0.516                  P=0.488         | 
|POLY 1.5           |                  P=0.528                  P=0.229                  P=0.510                  P=0.491         | 
|POLY 6             |                  P=0.517                  P=0.222                  P=0.522                  P=0.484         | 
|LOGISTIC REGRESSION|                  P=0.555                  P=0.234                  P=0.520                  P=0.543         | 
|COCH-ARM / FISHERS |                  P=0.547                  P=0.242                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.280                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Hyperkeratosis                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/48 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/40.42                  0/38.24                  0/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  5.0%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  647                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.139N                 P=0.270N                 P=0.207N                 P=0.274N        | 
|POLY 3             |                  P=0.124N                 P=0.249N                 P=0.221N                 P=0.256N        | 
|POLY 1.5           |                  P=0.130N                 P=0.243N                 P=0.227N                 P=0.250N        | 
|POLY 6             |                  P=0.116N                 P=0.259N                 P=0.216N                 P=0.263N        | 
|LOGISTIC REGRESSION|                  P=0.139N                 P=0.240N                 P=0.243N                 P=0.245N        | 
|COCH-ARM / FISHERS |                  P=0.139N                 P=0.247N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.036N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  2/38.32                  0/43.37                  0/37.18         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/23 (4%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      708                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.333N                 P=0.200                  (e)                      (e)             | 
|POLY 3             |                  P=0.324N                 P=0.227                  (e)                      (e)             | 
|POLY 1.5           |                  P=0.323N                 P=0.232                  (e)                      (e)             | 
|POLY 6             |                  P=0.327N                 P=0.219                  (e)                      (e)             | 
|LOGISTIC REGRESSION|                  P=0.326N                 P=0.212                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.321N                 P=0.247                  (e)                      (e)             | 
|ORDER RESTRICTED   |                  P=0.253N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               2/48 (4%)                7/48 (15%)               12/48 (25%)     | 
|POLY-3 RATE (b)    |                  6/43.71                  2/38.24                  7/44.56                  12/42.42        | 
|POLY-3 PERCENT (g) |                  13.7%                    5.2%                     15.7%                    28.3%           | 
|TERMINAL (d)       |                  0/29 (0%)                2/23 (9%)                4/32 (13%)               1/25 (4%)       | 
|FIRST INCIDENCE    |                  401                      728 (T)                  484                      323             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.010 *                P=0.171N                 P=0.557                  P=0.089         | 
|POLY 3             |                  P=0.010 *                P=0.179N                 P=0.515                  P=0.079         | 
|POLY 1.5           |                  P=0.009 **               P=0.158N                 P=0.509                  P=0.082         | 
|POLY 6             |                  P=0.013 *                P=0.209N                 P=0.520                  P=0.079         | 
|LOGISTIC REGRESSION|                  P=0.023 *                P=0.095N                 P=0.170                  P=0.195         | 
|COCH-ARM / FISHERS |                  P=0.009 **               P=0.134N                 P=0.500                  P=0.095         | 
|ORDER RESTRICTED   |                  P=0.010 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                2/48 (4%)                2/48 (4%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  1/40.42                  2/39.54                  2/43.78                  3/39.36         | 
|POLY-3 PERCENT (g) |                  2.5%                     5.1%                     4.6%                     7.6%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  626                      485                      652                      111             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.229                  P=0.485                  P=0.555                  P=0.286         | 
|POLY 3             |                  P=0.236                  P=0.492                  P=0.528                  P=0.295         | 
|POLY 1.5           |                  P=0.237                  P=0.497                  P=0.517                  P=0.299         | 
|POLY 6             |                  P=0.235                  P=0.484                  P=0.539                  P=0.290         | 
|LOGISTIC REGRESSION|                  P=0.507                  P=0.504                  P=0.448                  P=0.573         | 
|COCH-ARM / FISHERS |                  P=0.239                  P=0.500                  P=0.500                  P=0.308         | 
|ORDER RESTRICTED   |                  P=0.234                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                2/48 (4%)                1/48 (2%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/40.37                  2/39.39                  1/43.63                  0/37.18         | 
|POLY-3 PERCENT (g) |                  2.5%                     5.1%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  641                      485                      659                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.226N                 P=0.480                  P=0.719N                 P=0.530N        | 
|POLY 3             |                  P=0.232N                 P=0.491                  P=0.743N                 P=0.516N        | 
|POLY 1.5           |                  P=0.230N                 P=0.496                  P=0.750N                 P=0.511N        | 
|POLY 6             |                  P=0.235N                 P=0.483                  P=0.736N                 P=0.523N        | 
|LOGISTIC REGRESSION|                  P=0.155N                 P=0.513                  P=0.727                  P=0.489N        | 
|COCH-ARM / FISHERS |                  P=0.220N                 P=0.500                  P=0.753N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.237N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 39      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/46 (17%)               5/48 (10%)               11/47 (23%)              6/46 (13%)      | 
|POLY-3 RATE (b)    |                  8/39.19                  5/38.76                  11/43.50                 6/35.84         | 
|POLY-3 PERCENT (g) |                  20.4%                    12.9%                    25.3%                    16.7%           | 
|TERMINAL (d)       |                  5/29 (17%)               3/23 (13%)               7/31 (23%)               4/24 (17%)      | 
|FIRST INCIDENCE    |                  589                      598                      619                      654             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.528                  P=0.411N                 P=0.392                  P=0.513N        | 
|POLY 3             |                  P=0.515                  P=0.278N                 P=0.396                  P=0.456N        | 
|POLY 1.5           |                  P=0.526                  P=0.263N                 P=0.367                  P=0.434N        | 
|POLY 6             |                  P=0.507                  P=0.306N                 P=0.426                  P=0.483N        | 
|LOGISTIC REGRESSION|                  P=0.531                  P=0.280N                 P=0.367                  P=0.459N        | 
|COCH-ARM / FISHERS |                  P=0.531N                 P=0.249N                 P=0.323                  P=0.386N        | 
|ORDER RESTRICTED   |                  P=0.479                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                1/48 (2%)                1/47 (2%)                3/46 (7%)       | 
|POLY-3 RATE (b)    |                  0/38.38                  1/38.24                  1/42.37                  3/35.73         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     2.4%                     8.4%            | 
|TERMINAL (d)       |                  0/29 (0%)                1/23 (4%)                1/31 (3%)                2/24 (8%)       | 
|FIRST INCIDENCE    |                  ---                      728 (T)                  728 (T)                  619             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.047 *                P=0.454                  P=0.513                  P=0.097         | 
|POLY 3             |                  P=0.049 *                P=0.499                  P=0.520                  P=0.105         | 
|POLY 1.5           |                  P=0.050                  P=0.504                  P=0.514                  P=0.109         | 
|POLY 6             |                  P=0.049 *                P=0.492                  P=0.525                  P=0.101         | 
|LOGISTIC REGRESSION|                  P=0.045 *                P=0.454                  P=0.513                  P=0.107         | 
|COCH-ARM / FISHERS |                  P=0.054                  P=0.511                  P=0.505                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.031 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 40      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                0/48 (0%)                1/47 (2%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  0/38.38                  0/38.24                  1/42.37                  2/35.34         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.4%                     5.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/31 (3%)                2/24 (8%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.053                  (e)                      P=0.513                  P=0.197         | 
|POLY 3             |                  P=0.055                  (e)                      P=0.520                  P=0.218         | 
|POLY 1.5           |                  P=0.057                  (e)                      P=0.514                  P=0.224         | 
|POLY 6             |                  P=0.054                  (e)                      P=0.525                  P=0.212         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.513                  P=0.197         | 
|COCH-ARM / FISHERS |                  P=0.061                  (e)                      P=0.505                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.063                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Trachea                                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                3/48 (6%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  3/43.37                  1/37.94         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     6.9%                     2.6%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                3/32 (9%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.207                  (e)                      P=0.138                  P=0.491         | 
|POLY 3             |                  P=0.197                  (e)                      P=0.133                  P=0.489         | 
|POLY 1.5           |                  P=0.201                  (e)                      P=0.127                  P=0.492         | 
|POLY 6             |                  P=0.193                  (e)                      P=0.139                  P=0.486         | 
|LOGISTIC REGRESSION|                  P=0.229                  (e)                      P=0.138                  P=0.654         | 
|COCH-ARM / FISHERS |                  P=0.220                  (e)                      P=0.121                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.130                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 41      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Trachea: Epithelium                                                                                                              | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                1/48 (2%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  1/43.37                  2/38.16         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.3%                     5.2%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                1/32 (3%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      728 (T)                  454             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.059                  (e)                      P=0.520                  P=0.228         | 
|POLY 3             |                  P=0.061                  (e)                      P=0.516                  P=0.226         | 
|POLY 1.5           |                  P=0.061                  (e)                      P=0.510                  P=0.228         | 
|POLY 6             |                  P=0.061                  (e)                      P=0.522                  P=0.223         | 
|LOGISTIC REGRESSION|                  P=0.084                  (e)                      P=0.520                  P=0.294         | 
|COCH-ARM / FISHERS |                  P=0.064                  (e)                      P=0.500                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.067                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               3/48 (6%)                11/48 (23%)              8/48 (17%)      | 
|POLY-3 RATE (b)    |                  6/41.17                  3/38.24                  11/43.55                 8/37.40         | 
|POLY-3 PERCENT (g) |                  14.6%                    7.9%                     25.3%                    21.4%           | 
|TERMINAL (d)       |                  3/29 (10%)               3/23 (13%)               9/32 (28%)               7/25 (28%)      | 
|FIRST INCIDENCE    |                  589                      728 (T)                  697                      670             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.108                  P=0.343N                 P=0.213                  P=0.292         | 
|POLY 3             |                  P=0.097                  P=0.278N                 P=0.168                  P=0.311         | 
|POLY 1.5           |                  P=0.105                  P=0.260N                 P=0.159                  P=0.335         | 
|POLY 6             |                  P=0.089                  P=0.307N                 P=0.175                  P=0.280         | 
|LOGISTIC REGRESSION|                  P=0.101                  P=0.261N                 P=0.186                  P=0.322         | 
|COCH-ARM / FISHERS |                  P=0.132                  P=0.243N                 P=0.142                  P=0.387         | 
|ORDER RESTRICTED   |                  P=0.120                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93005 TEST: 03                                            Page 42      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                      MALACHITE GREEN                   
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/48 (6%)                3/48 (6%)                5/48 (10%)               1/48 (2%)       | 
|POLY-3 RATE (b)    |                  3/41.04                  3/39.04                  5/44.19                  1/37.76         | 
|POLY-3 PERCENT (g) |                  7.3%                     7.7%                     11.3%                    2.7%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                0/25 (0%)       | 
|FIRST INCIDENCE    |                  626                      556                      659                      546             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.301N                 P=0.614                  P=0.449                  P=0.342N        | 
|POLY 3             |                  P=0.312N                 P=0.640                  P=0.397                  P=0.335N        | 
|POLY 1.5           |                  P=0.304N                 P=0.651                  P=0.382                  P=0.326N        | 
|POLY 6             |                  P=0.322N                 P=0.622                  P=0.414                  P=0.348N        | 
|LOGISTIC REGRESSION|                  P=0.255N                 P=0.649N                 P=0.299                  P=0.255N        | 
|COCH-ARM / FISHERS |                  P=0.279N                 P=0.661N                 P=0.357                  P=0.308N        | 
|ORDER RESTRICTED   |                  P=0.239N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  300 PPM                  600 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Prolapse                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/48 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/40.06                  0/38.24                  0/43.37                  2/37.45         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/29 (0%)                0/23 (0%)                0/32 (0%)                1/25 (4%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      654             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.040 *                (e)                      (e)                      P=0.217         | 
|POLY 3             |                  P=0.042 *                (e)                      (e)                      P=0.222         | 
|POLY 1.5           |                  P=0.042 *                (e)                      (e)                      P=0.226         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.218         | 
|LOGISTIC REGRESSION|                  P=0.040 *                (e)                      (e)                      P=0.223         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.024 *                (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).