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TDMS Study 93029-03 Pathology Tables

                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                      REPORT: PEIRPT10     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 05/05/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 14:28:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  LEUKOMALACHITE GREEN                                                                            
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Adrenal Gland: Cortex                  Hyperplasia Focal                                                                            
Brain: Brain Stem, Hypothalamus        Compression                                                                                  
Eye                                    Hemorrhage                                                                                   
Eye: Bilateral, Retina                 Degeneration                                                                                 
Eye: Retina                            Degeneration                                                                                 
Intestine Large: Cecum, Lymphoid Tissue                                                                                             
                                       Hyperplasia                                                                                  
Kidney                                 Nephropathy                                                                                  
                                       Pigmentation                                                                                 
Liver                                  Degeneration Cystic                                                                          
                                       Eosinophilic Focus                                                                           
                                       Vacuolization Cytoplasmic                                                                    
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Centrilobular                   Necrosis                                                                                     
Lung: Alveolar Epithelium              Hyperplasia                                                                                  
Mammary Gland                          Galactocele                                                                                  
Mammary Gland: Duct                    Dilatation                                                                                   
Pancreas: Acinus                       Atrophy                                                                                      
Pancreas: Artery                       Inflammation Chronic                                                                         
Pituitary Gland: Pars Distalis         Hyperplasia                                                                                  
Preputial Gland                        Atrophy                                                                                      
                                       Inflammation                                                                                 
Prostate                               Inflammation                                                                                 
Prostate: Ventral                      Hyperplasia                                                                                  
Seminal Vesicle                        Decreased Secretory Fluid                                                                    
Skin: Epithelium                       Hyperplasia                                                                                  
Spleen                                 Fibrosis                                                                                     
                                       Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia Lymphoid                                                                         
Testes: Interstitial Cell              Hyperplasia                                                                                  
Testes: Seminiferous Tubule            Atrophy                                                                                      
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicle                Cyst                                                                                         
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Gland: Cortex                  Angiectasis                                                                                  
Bone: Femur                            Fibrous Osteodystrophy                                                                       
Clitoral Gland: Duct                   Dilatation                                                                                   
Eye                                    Cataract                                                                                     
Eye: Retina                            Degeneration                                                                                 
Liver                                  Basophilic Focus                                                                             
                                       Eosinophilic Focus                                                                           
                                       Inflammation Granulomatous Focal                                                             
                                       Vacuolization Cytoplasmic                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                      REPORT: PEIRPT10     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 05/05/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 14:28:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
Lymph Node: Mandibular                 Infiltration Cellular Plasma Cell                                                            
Mammary Gland                          Galactocele                                                                                  
Mammary Gland: Duct                    Dilatation                                                                                   
Mesentery: Fat                         Necrosis                                                                                     
Pituitary Gland: Pars Distalis         Cyst                                                                                         
Thyroid Gland: C-Cell                  Hyperplasia                                                                                  
Thyroid Gland: Follicular Cell         Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(F344/NCTR)  -                   LEUKOMALACHITE GREEN                    
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/46 (0%)    2/47 (4%)    1/47 (2%)   |0/47 (0%)    0/48 (0%)    3/46 (7%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/40.39      0/41.07      2/42.02      1/42.42     |0/42.64      0/44.68      3/41.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.8%         2.4%        |0.0%         0.0%         7.2%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/29 (0%)    2/33 (6%)    1/30 (3%)   |0/32 (0%)    0/36 (0%)    3/33 (9%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      733 (T)     |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.261      (e)          P=0.321      P=0.553     |P=0.502      (e)          P=0.126      (e)          | 
|POLY 3             |     P=0.237      (e)          P=0.246      P=0.510     |P=0.480      (e)          P=0.114      (e)          | 
|POLY 1.5           |     P=0.232      (e)          P=0.241      P=0.505     |P=0.490      (e)          P=0.112      (e)          | 
|POLY 6             |     P=0.246      (e)          P=0.257      P=0.517     |P=0.471      (e)          P=0.118      (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.321      P=0.553     |(e)          (e)          P=0.126      (e)          | 
|COCH-ARM / FISHERS |     P=0.225      (e)          P=0.247      P=0.500     |P=0.501      (e)          P=0.117      (e)          | 
|ORDER RESTRICTED   |     P=0.174      (e)          (e)          (e)         |P=0.158      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/46 (0%)    0/47 (0%)    0/47 (0%)   |8/47 (17%)   10/48 (21%)  2/46 (4%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     0/40.39      0/41.07      0/42.02      0/42.42     |8/42.64      10/44.69     2/41.73      3/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |18.8%        22.4%        4.8%         7.0%         | 
|TERMINAL (d)       |     0/23 (0%)    0/29 (0%)    0/33 (0%)    0/30 (0%)   |8/32 (25%)   9/36 (25%)   1/33 (3%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      732          719          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.014N*    P=0.506      P=0.041N*    P=0.078N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.016N*    P=0.439      P=0.047N*    P=0.096N     | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.016N*    P=0.421      P=0.050N     P=0.096N     | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.016N*    P=0.468      P=0.043N*    P=0.095N     | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.014N*    (e)          P=0.039N*    P=0.078N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.016N*    P=0.416      P=0.049N*    P=0.093N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.030N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    5/46 (11%)   3/47 (6%)    5/47 (11%)  |4/47 (9%)    2/48 (4%)    4/46 (9%)    5/48 (10%)   | 
|POLY-3 RATE (b)    |     0/40.39      5/41.07      3/42.02      5/42.45     |4/42.64      2/44.68      4/41.67      5/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         12.2%        7.1%         11.8%       |9.4%         4.5%         9.6%         11.7%        | 
|TERMINAL (d)       |     0/23 (0%)    5/29 (17%)   3/33 (9%)    4/30 (13%)  |4/32 (13%)   2/36 (6%)    4/33 (12%)   5/34 (15%)   | 
|FIRST INCIDENCE    |     ---          733 (T)      733 (T)      724         |734 (T)      734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.156      P=0.054      P=0.191      P=0.058     |P=0.282      P=0.283N     P=0.629N     P=0.539      | 
|POLY 3             |     P=0.121      P=0.031 *    P=0.125      P=0.034 *   |P=0.265      P=0.316N     P=0.631      P=0.500      | 
|POLY 1.5           |     P=0.113      P=0.030 *    P=0.121      P=0.032 *   |P=0.274      P=0.325N     P=0.625      P=0.503      | 
|POLY 6             |     P=0.134      P=0.034 *    P=0.134      P=0.037 *   |P=0.257      P=0.302N     P=0.644      P=0.501      | 
|LOGISTIC REGRESSION|     P=0.129      P=0.054      P=0.191      P=0.047 *   |P=0.282      P=0.283N     P=0.629N     P=0.539      | 
|COCH-ARM / FISHERS |     P=0.107      P=0.026 *    P=0.121      P=0.028 *   |P=0.284      P=0.329N     P=0.631      P=0.514      | 
|ORDER RESTRICTED   |     P=0.031 *    (e)          (e)          (e)         |P=0.341      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    1/46 (2%)    0/47 (0%)    1/47 (2%)   |2/47 (4%)    0/48 (0%)    2/46 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/40.39      1/41.07      0/42.02      1/42.42     |2/42.64      0/44.68      2/42.05      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         2.4%        |4.7%         0.0%         4.8%         0.0%         | 
|TERMINAL (d)       |     0/23 (0%)    1/29 (3%)    0/33 (0%)    1/30 (3%)   |2/32 (6%)    0/36 (0%)    1/33 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      ---          733 (T)     |734 (T)      ---          626          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.482      P=0.546      (e)          P=0.553     |P=0.290N     P=0.213N     P=0.685N     P=0.225N     | 
|POLY 3             |     P=0.454      P=0.503      (e)          P=0.510     |P=0.301N     P=0.227N     P=0.689      P=0.237N     | 
|POLY 1.5           |     P=0.447      P=0.500      (e)          P=0.505     |P=0.295N     P=0.231N     P=0.684      P=0.236N     | 
|POLY 6             |     P=0.465      P=0.510      (e)          P=0.517     |P=0.308N     P=0.220N     P=0.689N     P=0.236N     | 
|LOGISTIC REGRESSION|     (e)          P=0.546      (e)          P=0.553     |P=0.290N     (e)          P=0.686      (e)          | 
|COCH-ARM / FISHERS |     P=0.440      P=0.495      (e)          P=0.500     |P=0.289N     P=0.242N     P=0.683      P=0.242N     | 
|ORDER RESTRICTED   |     P=0.261      (e)          (e)          (e)         |P=0.115N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    2/46 (4%)    4/47 (9%)    2/47 (4%)   |2/47 (4%)    0/48 (0%)    0/46 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     1/40.75      2/41.87      4/42.66      2/42.59     |2/42.94      0/44.68      0/41.67      1/42.64      | 
|POLY-3 PERCENT (g) |     2.5%         4.8%         9.4%         4.7%        |4.7%         0.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/23 (0%)    0/29 (0%)    2/33 (6%)    1/30 (3%)   |1/32 (3%)    0/36 (0%)    0/33 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     632          615          543          687         |653          ---          ---          733          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.432      P=0.500      P=0.249      P=0.551     |P=0.503N     P=0.222N     P=0.234N     P=0.495N     | 
|POLY 3             |     P=0.406      P=0.509      P=0.192      P=0.515     |P=0.502N     P=0.228N     P=0.244N     P=0.502N     | 
|POLY 1.5           |     P=0.397      P=0.501      P=0.184      P=0.508     |P=0.499N     P=0.232N     P=0.245N     P=0.499N     | 
|POLY 6             |     P=0.420      P=0.524      P=0.208      P=0.528     |P=0.506N     P=0.223N     P=0.240N     P=0.504N     | 
|LOGISTIC REGRESSION|     P=0.367      P=0.480      P=0.178      P=0.485     |P=0.498N     P=0.229N     P=0.237N     P=0.495N     | 
|COCH-ARM / FISHERS |     P=0.386      P=0.492      P=0.181      P=0.500     |P=0.496N     P=0.242N     P=0.253N     P=0.492N     | 
|ORDER RESTRICTED   |     P=0.283      (e)          (e)          (e)         |P=0.132N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Medulla                                                                                                           | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    0/46 (0%)    3/47 (6%)    2/47 (4%)   |1/47 (2%)    0/48 (0%)    0/46 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/40.39      0/41.07      3/42.02      2/42.42     |1/43.00      0/44.68      0/41.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.5%         0.0%         7.1%         4.7%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    0/29 (0%)    3/33 (9%)    2/30 (7%)   |0/32 (0%)    0/36 (0%)    0/33 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          733 (T)      733 (T)     |635          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.262      P=0.454N     P=0.441      P=0.593     |P=0.337N     P=0.495N     P=0.500N     P=0.510N     | 
|POLY 3             |     P=0.222      P=0.497N     P=0.319      P=0.517     |P=0.330N     P=0.492N     P=0.506N     P=0.502N     | 
|POLY 1.5           |     P=0.216      P=0.500N     P=0.311      P=0.509     |P=0.329N     P=0.496N     P=0.508N     P=0.500N     | 
|POLY 6             |     P=0.229      P=0.490N     P=0.337      P=0.530     |P=0.332N     P=0.488N     P=0.503N     P=0.503N     | 
|LOGISTIC REGRESSION|     P=0.262      (e)          P=0.441      P=0.593     |P=0.324N     P=0.466N     P=0.467N     P=0.435N     | 
|COCH-ARM / FISHERS |     P=0.210      P=0.505N     P=0.308      P=0.500     |P=0.329N     P=0.495N     P=0.505N     P=0.495N     | 
|ORDER RESTRICTED   |     P=0.198      (e)          (e)          (e)         |P=0.122N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/47 (2%)    0/48 (0%)    1/47 (2%)   |4/48 (8%)    2/48 (4%)    4/48 (8%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     1/41.66      1/42.07      0/43.02      1/42.68     |4/44.60      2/44.68      4/44.06      3/43.16      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         0.0%         2.3%        |9.0%         4.5%         9.1%         7.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |2/33 (6%)    2/36 (6%)    2/35 (6%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     659          732          ---          661         |552          734 (T)      657          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.571N     P=0.734N     P=0.480N     P=0.737N    |P=0.561N     P=0.315N     P=0.621N     P=0.501N     | 
|POLY 3             |     P=0.599N     P=0.759N     P=0.494N     P=0.755N    |P=0.569N     P=0.336N     P=0.637      P=0.518N     | 
|POLY 1.5           |     P=0.601N     P=0.759      P=0.498N     P=0.760N    |P=0.560N     P=0.341N     P=0.633      P=0.512N     | 
|POLY 6             |     P=0.595N     P=0.753N     P=0.485N     P=0.748N    |P=0.569      P=0.328N     P=0.641N     P=0.521N     | 
|LOGISTIC REGRESSION|     P=0.610N     P=0.757      P=0.493N     P=0.745     |P=0.543N     P=0.324N     P=0.626N     P=0.435N     | 
|COCH-ARM / FISHERS |     P=0.603N     P=0.747      P=0.500N     P=0.747     |P=0.550N     P=0.339N     P=0.643N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.527N     (e)          (e)          (e)         |P=0.551N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    0/48 (0%)    2/47 (4%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.39      0/42.07      0/43.02      2/42.42     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         0.0%         4.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/24 (8%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          733 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.508      P=0.190N     P=0.165N     P=0.613N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.454      P=0.233N     P=0.228N     P=0.685N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.453      P=0.238N     P=0.234N     P=0.693N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.454      P=0.226N     P=0.218N     P=0.673N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.508      (e)          (e)          P=0.613N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.453      P=0.253N     P=0.247N     P=0.684     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.259N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow: Myeloid Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    2/48 (4%)    1/47 (2%)   |0/48 (0%)    1/48 (2%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.07      2/43.91      1/43.09     |0/43.64      1/45.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         4.6%         2.3%        |0.0%         2.2%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      543          505         |---          60           ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.385      P=0.545      P=0.246      P=0.492     |P=0.500N     P=0.500      (e)          (e)          | 
|POLY 3             |     P=0.393      P=0.503      P=0.250      P=0.508     |P=0.494N     P=0.509      (e)          (e)          | 
|POLY 1.5           |     P=0.381      P=0.500      P=0.243      P=0.502     |P=0.498N     P=0.505      (e)          (e)          | 
|POLY 6             |     P=0.409      P=0.510      P=0.264      P=0.516     |P=0.488N     P=0.515      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.366      P=0.545      P=0.290      P=0.866     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.366      P=0.495      P=0.247      P=0.495     |P=0.500N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.237      (e)          (e)          (e)         |P=0.393N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/48 (0%)    2/47 (4%)   |2/48 (4%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      0/43.02      2/42.59     |2/44.22      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         4.7%        |4.5%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          687         |552          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.248      P=0.455N     P=0.431N     P=0.562     |P=0.142N     P=0.232N     P=0.240N     P=0.244N     | 
|POLY 3             |     P=0.223      P=0.497N     P=0.492N     P=0.510     |P=0.138N     P=0.235N     P=0.240N     P=0.245N     | 
|POLY 1.5           |     P=0.222      P=0.500N     P=0.497N     P=0.502     |P=0.137N     P=0.238N     P=0.241N     P=0.243N     | 
|POLY 6             |     P=0.225      P=0.490N     P=0.483N     P=0.524     |P=0.139N     P=0.230N     P=0.236N     P=0.247N     | 
|LOGISTIC REGRESSION|     P=0.231      (e)          (e)          P=0.522     |P=0.132N     P=0.202N     P=0.195N     P=0.173N     | 
|COCH-ARM / FISHERS |     P=0.221      P=0.505N     P=0.500N     P=0.492     |P=0.138N     P=0.247N     P=0.247N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.136      (e)          (e)          (e)         |P=0.032N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    4/48 (8%)    3/48 (6%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |1/43.64      4/44.76      3/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         8.9%         6.9%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    3/36 (8%)    3/35 (9%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      714          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.386N     P=0.208      P=0.326      P=0.755N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.397N     P=0.186      P=0.305      P=0.755      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.393N     P=0.180      P=0.302      P=0.757      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.398N     P=0.196      P=0.313      P=0.756      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.396N     P=0.205      P=0.326      P=0.755N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.383N     P=0.181      P=0.308      P=0.753N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.339      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    4/48 (8%)    4/48 (8%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |1/43.64      4/44.76      4/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         8.9%         9.2%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    3/36 (8%)    4/35 (11%)   1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      714          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.419N     P=0.208      P=0.196      P=0.755N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.434N     P=0.186      P=0.178      P=0.755      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.428N     P=0.180      P=0.175      P=0.757      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.436N     P=0.196      P=0.185      P=0.756      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.430N     P=0.205      P=0.196      P=0.755N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.417N     P=0.181      P=0.181      P=0.753N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.288      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Turbinate                                                                                                                  | 
|     Osteopetrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    3/48 (6%)    4/48 (8%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |1/43.64      3/44.76      4/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         6.7%         9.2%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    2/36 (6%)    4/35 (11%)   1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      714          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.504N     P=0.337      P=0.196      P=0.755N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.519N     P=0.314      P=0.178      P=0.755      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.512N     P=0.307      P=0.175      P=0.757      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.522N     P=0.325      P=0.185      P=0.756      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.516N     P=0.333      P=0.196      P=0.755N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.501N     P=0.308      P=0.181      P=0.753N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.338      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain: Brain Stem                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.68      2/43.28      0/43.02      0/42.42     |1/43.87      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         4.6%         0.0%         0.0%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     653          487          ---          ---         |673          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.153N     P=0.500      P=0.485N     P=0.480N    |P=0.335N     P=0.475N     P=0.480N     P=0.505N     | 
|POLY 3             |     P=0.150N     P=0.513      P=0.494N     P=0.497N    |P=0.330N     P=0.496N     P=0.501N     P=0.506N     | 
|POLY 1.5           |     P=0.153N     P=0.504      P=0.498N     P=0.500N    |P=0.330N     P=0.500N     P=0.503N     P=0.504N     | 
|POLY 6             |     P=0.145N     P=0.527      P=0.485N     P=0.491N    |P=0.331N     P=0.492N     P=0.497N     P=0.507N     | 
|LOGISTIC REGRESSION|     P=0.107N     P=0.516      P=0.490N     P=0.516N    |P=0.326N     P=0.489N     P=0.486N     P=0.478N     | 
|COCH-ARM / FISHERS |     P=0.156N     P=0.492      P=0.500N     P=0.505N    |P=0.330N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.171N     (e)          (e)          (e)         |P=0.126N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain: Brain Stem, Hypothalamus                                                                                                  | 
|     Compression                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/48 (19%)   4/47 (9%)    6/48 (13%)   1/47 (2%)   |11/48 (23%)  6/48 (13%)   5/48 (10%)   5/48 (10%)   | 
|POLY-3 RATE (b)    |     9/43.29      4/43.34      6/43.28      1/42.62     |11/44.55     6/45.20      5/43.77      5/42.99      | 
|POLY-3 PERCENT (g) |     20.8%        9.2%         13.9%        2.4%        |24.7%        13.3%        11.4%        11.6%        | 
|TERMINAL (d)       |     2/24 (8%)    0/30 (0%)    5/34 (15%)   0/30 (0%)   |6/33 (18%)   4/36 (11%)   4/35 (11%)   4/34 (12%)   | 
|FIRST INCIDENCE    |     541          567          662          679         |662          605          709          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.014N*    P=0.100N     P=0.164N     P=0.009N**  |P=0.097N     P=0.118N     P=0.078N     P=0.093N     | 
|POLY 3             |     P=0.017N*    P=0.113N     P=0.285N     P=0.008N**  |P=0.098N     P=0.132N     P=0.088N     P=0.094N     | 
|POLY 1.5           |     P=0.017N*    P=0.118N     P=0.291N     P=0.008N**  |P=0.093N     P=0.141N     P=0.090N     P=0.091N     | 
|POLY 6             |     P=0.017N*    P=0.103N     P=0.268N     P=0.007N**  |P=0.104N     P=0.122N     P=0.084N     P=0.097N     | 
|LOGISTIC REGRESSION|     P=0.020N*    P=0.145N     P=0.291N     P=0.013N*   |P=0.093N     P=0.142N     P=0.085N     P=0.091N     | 
|COCH-ARM / FISHERS |     P=0.018N*    P=0.124N     P=0.288N     P=0.008N**  |P=0.087N     P=0.142N     P=0.085N     P=0.085N     | 
|ORDER RESTRICTED   |     P=0.004N**   (e)          (e)          (e)         |P=0.064N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |4/47 (9%)    4/47 (9%)    5/46 (11%)   3/47 (6%)    | 
|POLY-3 RATE (b)    |                                                        |4/43.22      4/43.85      5/41.83      3/42.13      | 
|POLY-3 PERCENT (g) |                                                        |9.3%         9.1%         12.0%        7.1%         | 
|TERMINAL (d)       |                                                        |3/33 (9%)    4/36 (11%)   5/35 (14%)   3/34 (9%)    | 
|FIRST INCIDENCE    |                                                        |718          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.432N     P=0.597N     P=0.535      P=0.486N     | 
|POLY 3             |                                                        |P=0.457N     P=0.635N     P=0.480      P=0.514N     | 
|POLY 1.5           |                                                        |P=0.448N     P=0.643      P=0.476      P=0.510N     | 
|POLY 6             |                                                        |P=0.463N     P=0.622N     P=0.490      P=0.515N     | 
|LOGISTIC REGRESSION|                                                        |P=0.446N     P=0.592N     P=0.523      P=0.500N     | 
|COCH-ARM / FISHERS |                                                        |P=0.434N     P=0.643N     P=0.486      P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.504N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |23/47 (49%)  31/47 (66%)  22/46 (48%)  28/47 (60%)  | 
|POLY-3 RATE (b)    |                                                        |23/45.16     31/46.44     22/43.69     28/44.84     | 
|POLY-3 PERCENT (g) |                                                        |50.9%        66.8%        50.4%        62.5%        | 
|TERMINAL (d)       |                                                        |16/33 (49%)  23/36 (64%)  17/35 (49%)  21/34 (62%)  | 
|FIRST INCIDENCE    |                                                        |552          60           470          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.400      P=0.192      P=0.420N     P=0.253      | 
|POLY 3             |                                                        |P=0.357      P=0.089      P=0.563N     P=0.184      | 
|POLY 1.5           |                                                        |P=0.366      P=0.080      P=0.569N     P=0.187      | 
|POLY 6             |                                                        |P=0.360      P=0.105      P=0.552N     P=0.192      | 
|LOGISTIC REGRESSION|                                                        |P=0.405      P=0.071      P=0.549N     P=0.198      | 
|COCH-ARM / FISHERS |                                                        |P=0.404      P=0.072      P=0.540N     P=0.204      | 
|ORDER RESTRICTED   |                                                        |P=0.206      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |25/47 (53%)  24/47 (51%)  18/46 (39%)  15/47 (32%)  | 
|POLY-3 RATE (b)    |                                                        |25/44.40     24/44.59     18/42.15     15/43.56     | 
|POLY-3 PERCENT (g) |                                                        |56.3%        53.8%        42.7%        34.4%        | 
|TERMINAL (d)       |                                                        |21/33 (64%)  20/36 (56%)  16/35 (46%)  12/34 (35%)  | 
|FIRST INCIDENCE    |                                                        |552          561          676          405          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.013N*    P=0.343N     P=0.068N     P=0.028N*    | 
|POLY 3             |                                                        |P=0.012N*    P=0.491N     P=0.143N     P=0.029N*    | 
|POLY 1.5           |                                                        |P=0.012N*    P=0.514N     P=0.146N     P=0.029N*    | 
|POLY 6             |                                                        |P=0.012N*    P=0.454N     P=0.131N     P=0.027N*    | 
|LOGISTIC REGRESSION|                                                        |P=0.015N*    P=0.464N     P=0.117N     P=0.034N*    | 
|COCH-ARM / FISHERS |                                                        |P=0.012N*    P=0.500N     P=0.125N     P=0.030N*    | 
|ORDER RESTRICTED   |                                                        |P=0.024N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 10      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Coagulating Gland                                                                                                                | 
|     Decreased Secretory Fluid                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/46 (4%)    0/45 (0%)    0/47 (0%)    3/46 (7%)   |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|POLY-3 RATE (b)    |     2/39.73      0/40.54      0/42.02      3/42.06     |0/0.00       0/0.00       0/0.00       0/0.00       | 
|POLY-3 PERCENT (g) |     5.0%         0.0%         0.0%         7.1%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/22 (5%)    0/30 (0%)    0/33 (0%)    0/30 (0%)   |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     | 
|FIRST INCIDENCE    |     639          ---          ---          661         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.248      P=0.209N     P=0.188N     P=0.568     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.218      P=0.232N     P=0.224N     P=0.526     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.217      P=0.237N     P=0.229N     P=0.513     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.219      P=0.224N     P=0.215N     P=0.547     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.213      P=0.249N     P=0.234N     P=0.488     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.218      P=0.253N     P=0.242N     P=0.500     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.111      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/48 (10%)   3/47 (6%)    3/48 (6%)    4/47 (9%)   |3/48 (6%)    1/48 (2%)    0/48 (0%)    7/48 (15%)   | 
|POLY-3 RATE (b)    |     5/42.13      3/43.04      3/43.84      4/42.67     |3/44.00      1/45.12      0/43.67      7/43.24      | 
|POLY-3 PERCENT (g) |     11.9%        7.0%         6.8%         9.4%        |6.8%         2.2%         0.0%         16.2%        | 
|TERMINAL (d)       |     3/24 (13%)   1/30 (3%)    1/34 (3%)    2/30 (7%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    6/34 (18%)   | 
|FIRST INCIDENCE    |     623          567          439          676         |673          605          ---          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.435N     P=0.302N     P=0.251N     P=0.395N    |P=0.029 *    P=0.282N     P=0.113N     P=0.171      | 
|POLY 3             |     P=0.499N     P=0.344N     P=0.334N     P=0.492N    |P=0.024 *    P=0.296N     P=0.120N     P=0.149      | 
|POLY 1.5           |     P=0.503N     P=0.356N     P=0.346N     P=0.502N    |P=0.025 *    P=0.303N     P=0.121N     P=0.152      | 
|POLY 6             |     P=0.493N     P=0.325N     P=0.312N     P=0.475N    |P=0.023 *    P=0.286N     P=0.117N     P=0.148      | 
|LOGISTIC REGRESSION|     P=0.528N     P=0.395N     P=0.352N     P=0.505N    |P=0.030 *    P=0.288N     P=0.120N     P=0.156      | 
|COCH-ARM / FISHERS |     P=0.507N     P=0.369N     P=0.357N     P=0.514N    |P=0.029 *    P=0.308N     P=0.121N     P=0.158      | 
|ORDER RESTRICTED   |     P=0.399N     (e)          (e)          (e)         |P=0.006 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 11      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.93      0/42.07      0/43.02      0/42.42     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     564          ---          ---          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.130N     P=0.218N     P=0.208N     P=0.220N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.140N     P=0.236N     P=0.231N     P=0.234N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.139N     P=0.239N     P=0.235N     P=0.238N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.142N     P=0.230N     P=0.222N     P=0.228N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.136N     P=0.251N     P=0.219N     P=0.253N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.139N     P=0.253N     P=0.247N     P=0.253N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.028N*    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye                                                                                                                              | 
|     Phthisis Bulbi                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/48 (0%)    1/48 (2%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |0/43.64      1/44.68      1/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.2%         2.3%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    1/36 (3%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.158      P=0.517      P=0.512      P=0.245      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.154      P=0.505      P=0.500      P=0.232      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.157      P=0.501      P=0.498      P=0.233      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.153      P=0.510      P=0.505      P=0.232      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.517      P=0.512      P=0.245      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.160      P=0.500      P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.114      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 12      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral                                                                                                                   | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    1/48 (2%)    3/47 (6%)   |1/48 (2%)    1/48 (2%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     2/41.75      0/42.07      1/43.06      3/42.67     |1/43.71      1/45.12      0/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         2.3%         7.0%        |2.3%         2.2%         0.0%         4.7%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     632          ---          724          676         |718          605          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.241      P=0.218N     P=0.425N     P=0.573     |P=0.366      P=0.749N     P=0.495N     P=0.507      | 
|POLY 3             |     P=0.209      P=0.235N     P=0.489N     P=0.510     |P=0.362      P=0.753N     P=0.500N     P=0.491      | 
|POLY 1.5           |     P=0.207      P=0.239N     P=0.496N     P=0.500     |P=0.366      P=0.758N     P=0.502N     P=0.494      | 
|POLY 6             |     P=0.212      P=0.229N     P=0.474N     P=0.525     |P=0.359      P=0.746N     P=0.496N     P=0.491      | 
|LOGISTIC REGRESSION|     P=0.206      P=0.249N     P=0.500N     P=0.492     |P=0.372      P=0.750N     P=0.500N     P=0.496      | 
|COCH-ARM / FISHERS |     P=0.204      P=0.253N     P=0.500N     P=0.490     |P=0.371      P=0.753N     P=0.500N     P=0.500      | 
|ORDER RESTRICTED   |     P=0.192      (e)          (e)          (e)         |P=0.260      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral, Retina                                                                                                           | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/44 (2%)    0/42 (0%)    0/45 (0%)    5/44 (11%)  |4/43 (9%)    4/47 (9%)    5/47 (11%)   7/45 (16%)   | 
|POLY-3 RATE (b)    |     1/37.79      0/39.05      0/40.96      5/39.87     |4/39.95      4/44.12      5/42.91      7/41.16      | 
|POLY-3 PERCENT (g) |     2.7%         0.0%         0.0%         12.5%       |10.0%        9.1%         11.7%        17.0%        | 
|TERMINAL (d)       |     1/22 (5%)    0/30 (0%)    0/34 (0%)    5/30 (17%)  |3/32 (9%)    4/36 (11%)   4/35 (11%)   7/34 (21%)   | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          733 (T)     |719          734 (T)      698          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.010 *    P=0.438N     P=0.413N     P=0.183     |P=0.167      P=0.580N     P=0.554      P=0.294      | 
|POLY 3             |     P=0.006 **   P=0.493N     P=0.484N     P=0.112     |P=0.159      P=0.588N     P=0.545      P=0.276      | 
|POLY 1.5           |     P=0.006 **   P=0.501N     P=0.490N     P=0.107     |P=0.164      P=0.596N     P=0.543      P=0.280      | 
|POLY 6             |     P=0.006 **   P=0.482N     P=0.473N     P=0.122     |P=0.154      P=0.577N     P=0.553      P=0.274      | 
|LOGISTIC REGRESSION|     P=0.010 *    (e)          (e)          P=0.183     |P=0.154      P=0.559N     P=0.557      P=0.287      | 
|COCH-ARM / FISHERS |     P=0.008 **   P=0.512N     P=0.494N     P=0.101     |P=0.169      P=0.592N     P=0.557      P=0.288      | 
|ORDER RESTRICTED   |     P=0.004 **   (e)          (e)          (e)         |P=0.244      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 13      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Retina                                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/44 (20%)   3/42 (7%)    3/45 (7%)    7/44 (16%)  |4/43 (9%)    7/47 (15%)   11/47 (23%)  16/45 (36%)  | 
|POLY-3 RATE (b)    |     9/38.54      3/39.19      3/41.00      7/39.87     |4/39.95      7/44.51      11/43.41     16/42.06     | 
|POLY-3 PERCENT (g) |     23.4%        7.7%         7.3%         17.6%       |10.0%        15.7%        25.3%        38.0%        | 
|TERMINAL (d)       |     6/22 (27%)   2/30 (7%)    2/34 (6%)    7/30 (23%)  |3/32 (9%)    6/36 (17%)   8/35 (23%)   14/34 (41%)  | 
|FIRST INCIDENCE    |     623          697          722          733 (T)     |719          625          657          536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376N     P=0.026N*    P=0.015N*    P=0.188N    |P<0.001 **   P=0.326      P=0.072      P=0.004 **   | 
|POLY 3             |     P=0.508N     P=0.052N     P=0.043N*    P=0.361N    |P<0.001 **   P=0.325      P=0.060      P=0.002 **   | 
|POLY 1.5           |     P=0.506N     P=0.059N     P=0.048N*    P=0.376N    |P<0.001 **   P=0.315      P=0.059      P=0.002 **   | 
|POLY 6             |     P=0.511N     P=0.042N*    P=0.036N*    P=0.337N    |P<0.001 **   P=0.341      P=0.065      P=0.002 **   | 
|LOGISTIC REGRESSION|     P=0.460N     P=0.050N     P=0.039N*    P=0.299N    |P<0.001 **   P=0.320      P=0.060      P=0.003 **   | 
|COCH-ARM / FISHERS |     P=0.501N     P=0.069N     P=0.054N     P=0.392N    |P<0.001 **   P=0.315      P=0.064      P=0.003 **   | 
|ORDER RESTRICTED   |     P=0.080N     (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Sclera                                                                                                                      | 
|     Metaplasia Osseous                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    1/48 (2%)    1/47 (2%)   |1/48 (2%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/42.07      0/42.07      1/43.02      1/43.09     |1/43.91      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         2.3%         2.3%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     577          ---          733 (T)      505         |662          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.530N     P=0.230N     P=0.444N     P=0.498N    |P=0.340N     P=0.490N     P=0.495N     P=0.515N     | 
|POLY 3             |     P=0.543N     P=0.237N     P=0.492N     P=0.492N    |P=0.330N     P=0.497N     P=0.501N     P=0.506N     | 
|POLY 1.5           |     P=0.545N     P=0.240N     P=0.498N     P=0.499N    |P=0.330N     P=0.500N     P=0.503N     P=0.504N     | 
|POLY 6             |     P=0.541N     P=0.232N     P=0.479N     P=0.481N    |P=0.331N     P=0.492N     P=0.498N     P=0.507N     | 
|LOGISTIC REGRESSION|     P=0.549N     P=0.246N     P=0.495N     P=0.494N    |P=0.325N     P=0.484N     P=0.480N     P=0.468N     | 
|COCH-ARM / FISHERS |     P=0.547N     P=0.253N     P=0.500N     P=0.508N    |P=0.330N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.264N     (e)          (e)          (e)         |P=0.126N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 14      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     16/48 (33%)  16/47 (34%)  16/48 (33%)  18/47 (38%) |19/48 (40%)  26/48 (54%)  22/48 (46%)  21/48 (44%)  | 
|POLY-3 RATE (b)    |     16/43.42     16/42.87     16/44.04     18/44.55    |19/43.99     26/45.82     22/44.14     21/44.47     | 
|POLY-3 PERCENT (g) |     36.9%        37.3%        36.3%        40.4%       |43.2%        56.8%        49.8%        47.2%        | 
|TERMINAL (d)       |     9/24 (38%)   12/30 (40%)  14/34 (41%)  10/30 (33%) |17/33 (52%)  20/36 (56%)  19/35 (54%)  17/34 (50%)  | 
|FIRST INCIDENCE    |     564          615          477          505         |662          605          657          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.517N     P=0.358N     P=0.241N     P=0.519N    |P=0.502N     P=0.210      P=0.432      P=0.450      | 
|POLY 3             |     P=0.403      P=0.571      P=0.569N     P=0.451     |P=0.494N     P=0.138      P=0.338      P=0.433      | 
|POLY 1.5           |     P=0.372      P=0.562      P=0.582N     P=0.419     |P=0.493N     P=0.115      P=0.322      P=0.422      | 
|POLY 6             |     P=0.454      P=0.590N     P=0.533N     P=0.504     |P=0.488N     P=0.179      P=0.376      P=0.457      | 
|LOGISTIC REGRESSION|     P=0.360      P=0.577N     P=0.568N     P=0.377     |P=0.515      P=0.151      P=0.415      P=0.377      | 
|COCH-ARM / FISHERS |     P=0.340      P=0.557      P=0.586N     P=0.386     |P=0.488N     P=0.110      P=0.340      P=0.418      | 
|ORDER RESTRICTED   |     P=0.569      (e)          (e)          (e)         |P=0.351      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     37/48 (77%)  36/47 (77%)  40/48 (83%)  40/47 (85%) |35/48 (73%)  35/48 (73%)  33/48 (69%)  30/48 (63%)  | 
|POLY-3 RATE (b)    |     37/46.02     36/44.82     40/45.78     40/45.03    |35/46.34     35/45.82     33/45.13     30/46.00     | 
|POLY-3 PERCENT (g) |     80.4%        80.3%        87.4%        88.8%       |75.5%        76.4%        73.1%        65.2%        | 
|TERMINAL (d)       |     19/24 (79%)  26/30 (87%)  32/34 (94%)  28/30 (93%) |25/33 (76%)  29/36 (81%)  25/35 (71%)  22/34 (65%)  | 
|FIRST INCIDENCE    |     541          567          477          601         |552          605          599          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.432N     P=0.153N     P=0.134N     P=0.333N    |P=0.183N     P=0.364N     P=0.307N     P=0.218N     | 
|POLY 3             |     P=0.101      P=0.605N     P=0.254      P=0.190     |P=0.116N     P=0.559      P=0.491N     P=0.190N     | 
|POLY 1.5           |     P=0.110      P=0.594N     P=0.263      P=0.201     |P=0.117N     P=0.544      P=0.489N     P=0.195N     | 
|POLY 6             |     P=0.103      P=0.611N     P=0.269      P=0.194     |P=0.108N     P=0.585      P=0.463N     P=0.178N     | 
|LOGISTIC REGRESSION|     P=0.170      P=0.524N     P=0.311      P=0.302     |P=0.155N     P=0.568N     P=0.442N     P=0.203N     | 
|COCH-ARM / FISHERS |     P=0.138      P=0.574N     P=0.305      P=0.231     |P=0.123N     P=0.591N     P=0.411N     P=0.191N     | 
|ORDER RESTRICTED   |     P=0.186      (e)          (e)          (e)         |P=0.183N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 15      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart: Atrium                                                                                                                    | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    0/48 (0%)    3/47 (6%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.52      2/42.24      0/43.02      3/42.55     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         4.7%         0.0%         7.1%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     698          697          ---          698         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.295      P=0.550      P=0.461N     P=0.364     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.269      P=0.506      P=0.493N     P=0.314     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.264      P=0.499      P=0.497N     P=0.306     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.277      P=0.518      P=0.484N     P=0.326     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.271      P=0.502      P=0.499N     P=0.322     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.259      P=0.492      P=0.500N     P=0.301     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.192      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large: Cecum, Lymphoid Tissue                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/47 (6%)    1/47 (2%)    0/47 (0%)    0/47 (0%)   |0/47 (0%)    1/47 (2%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     3/40.90      1/42.07      0/42.06      0/42.42     |0/42.87      1/43.82      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     7.3%         2.4%         0.0%         0.0%        |0.0%         2.3%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     599          733 (T)      ---          ---         |---          725          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.039N*    P=0.246N     P=0.088N     P=0.102N    |P=0.499N     P=0.528      (e)          (e)          | 
|POLY 3             |     P=0.047N*    P=0.295N     P=0.113N     P=0.112N    |P=0.494N     P=0.504      (e)          (e)          | 
|POLY 1.5           |     P=0.048N*    P=0.300N     P=0.117N     P=0.115N    |P=0.497N     P=0.501      (e)          (e)          | 
|POLY 6             |     P=0.047N*    P=0.285N     P=0.106N     P=0.106N    |P=0.488N     P=0.510      (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.049N*    P=0.306N     P=0.121N     P=0.127N    |P=0.503N     P=0.509      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.049N*    P=0.308N     P=0.121N     P=0.121N    |P=0.496N     P=0.500      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.018N*    (e)          (e)          (e)         |P=0.386N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 16      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Large: Colon, Lymphoid Tissue                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/47 (0%)    2/47 (4%)    1/47 (2%)   |0/47 (0%)    1/47 (2%)    1/48 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/40.39      0/42.07      2/42.06      1/42.42     |0/42.87      1/43.82      1/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         4.8%         2.4%        |0.0%         2.3%         2.3%         2.4%         | 
|TERMINAL (d)       |     0/23 (0%)    0/30 (0%)    2/34 (6%)    1/30 (3%)   |0/33 (0%)    0/36 (0%)    1/35 (3%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      733 (T)     |---          725          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.257      (e)          P=0.328      P=0.553     |P=0.399      P=0.528      P=0.512      P=0.506      | 
|POLY 3             |     P=0.235      (e)          P=0.246      P=0.510     |P=0.394      P=0.504      P=0.504      P=0.499      | 
|POLY 1.5           |     P=0.229      (e)          P=0.241      P=0.505     |P=0.399      P=0.501      P=0.502      P=0.500      | 
|POLY 6             |     P=0.243      (e)          P=0.258      P=0.517     |P=0.391      P=0.510      P=0.508      P=0.498      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.328      P=0.553     |P=0.391      P=0.509      P=0.512      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.223      (e)          P=0.247      P=0.500     |P=0.405      P=0.500      P=0.505      P=0.505      | 
|ORDER RESTRICTED   |     P=0.175      (e)          (e)          (e)         |P=0.327      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Ileum, Lymphoid Tissue                                                                                          | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/47 (9%)    1/45 (2%)    1/46 (2%)    3/46 (7%)   |1/46 (2%)    2/48 (4%)    1/48 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     4/40.39      1/40.70      1/41.84      3/42.08     |1/41.94      2/44.72      1/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     9.9%         2.5%         2.4%         7.1%        |2.4%         4.5%         2.3%         0.0%         | 
|TERMINAL (d)       |     4/23 (17%)   1/30 (3%)    1/34 (3%)    2/30 (7%)   |1/33 (3%)    1/36 (3%)    1/35 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      733 (T)      601         |734 (T)      725          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.477N     P=0.106N     P=0.080N     P=0.373N    |P=0.219N     P=0.536      P=0.749N     P=0.494N     | 
|POLY 3             |     P=0.555N     P=0.175N     P=0.167N     P=0.478N    |P=0.220N     P=0.522      P=0.752N     P=0.497N     | 
|POLY 1.5           |     P=0.558N     P=0.183N     P=0.176N     P=0.494N    |P=0.218N     P=0.516      P=0.754N     P=0.495N     | 
|POLY 6             |     P=0.552N     P=0.162N     P=0.151N     P=0.451N    |P=0.221N     P=0.532      P=0.748N     P=0.497N     | 
|LOGISTIC REGRESSION|     P=0.534N     P=0.106N     P=0.080N     P=0.470N    |P=0.220N     P=0.542      P=0.749N     (e)          | 
|COCH-ARM / FISHERS |     P=0.561N     P=0.194N     P=0.187N     P=0.512N    |P=0.213N     P=0.516      P=0.742N     P=0.489N     | 
|ORDER RESTRICTED   |     P=0.186N     (e)          (e)          (e)         |P=0.236N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 17      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum, Lymphoid Tissue                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/47 (2%)    0/45 (0%)    0/46 (0%)    2/46 (4%)   |0/46 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/40.39      0/40.70      0/41.84      2/41.67     |0/41.94      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.5%         0.0%         0.0%         4.8%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/23 (4%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          724         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250      P=0.447N     P=0.422N     P=0.577     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.224      P=0.498N     P=0.493N     P=0.511     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.223      P=0.503N     P=0.499N     P=0.502     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.225      P=0.490N     P=0.482N     P=0.525     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.240      (e)          (e)          P=0.554     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.223      P=0.511N     P=0.505N     P=0.492     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.137      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |47/48 (98%)  46/48 (96%)  47/48 (98%)  48/48 (100%) | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |47/48.00     46/46.90     47/48.00     48/48.00     | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |97.9%        98.1%        97.9%        100.0%       | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |32/33 (97%)  36/36 (100%) 34/35 (97%)  34/34 (100%) | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |552          561          102          405          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.374      P=0.233N     P=0.401N     P=0.543      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.313      P=0.754      P=0.760      P=0.500      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.306      P=0.764      P=0.760      P=0.500      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.320      P=0.741      P=0.760      P=0.500      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.203      P=0.687N     (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.220      P=0.500N     P=0.753N     P=0.500      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.316      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 18      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     43/48 (90%)  45/47 (96%)  46/48 (96%)  47/47 (100%)|34/48 (71%)  31/48 (65%)  27/48 (56%)  29/48 (60%)  | 
|POLY-3 RATE (b)    |     43/46.51     45/46.06     46/47.18     47/47.00    |34/45.24     31/45.42     27/44.31     29/43.22     | 
|POLY-3 PERCENT (g) |     92.5%        97.7%        97.5%        100.0%      |75.2%        68.3%        60.9%        67.1%        | 
|TERMINAL (d)       |     23/24 (96%)  30/30 (100%) 34/34 (100%) 30/30 (100%)|27/33 (82%)  26/36 (72%)  23/35 (66%)  26/34 (77%)  | 
|FIRST INCIDENCE    |     541          567          435          475         |589          605          626          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.358N     P=0.237N     P=0.090N     P=0.341N    |P=0.173N     P=0.169N     P=0.060N     P=0.152N     | 
|POLY 3             |     P=0.038 *    P=0.214      P=0.233      P=0.056     |P=0.235N     P=0.304N     P=0.103N     P=0.264N     | 
|POLY 1.5           |     P=0.028 *    P=0.210      P=0.209      P=0.041 *   |P=0.201N     P=0.339N     P=0.113N     P=0.236N     | 
|POLY 6             |     P=0.073      P=0.248      P=0.322      P=0.100     |P=0.274N     P=0.258N     P=0.085N     P=0.294N     | 
|LOGISTIC REGRESSION|     P=0.019 *    P=0.242      P=0.164      P=0.038 *   |P=0.235N     P=0.206N     P=0.066N     P=0.221N     | 
|COCH-ARM / FISHERS |     P=0.027 *    P=0.226      P=0.218      P=0.030 *   |P=0.164N     P=0.331N     P=0.101N     P=0.195N     | 
|ORDER RESTRICTED   |     P=0.010 *    (e)          (e)          (e)         |P=0.192N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    1/47 (2%)    1/48 (2%)    0/47 (0%)   |2/48 (4%)    0/48 (0%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     3/41.84      1/42.31      1/43.81      0/42.42     |2/44.25      0/44.68      0/43.67      2/42.85      | 
|POLY-3 PERCENT (g) |     7.2%         2.4%         2.3%         0.0%        |4.5%         0.0%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     662          667          439          ---         |627          ---          ---          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.076N     P=0.268N     P=0.263N     P=0.110N    |P=0.446      P=0.226N     P=0.231N     P=0.690      | 
|POLY 3             |     P=0.082N     P=0.301N     P=0.289N     P=0.116N    |P=0.448      P=0.235N     P=0.240N     P=0.682      | 
|POLY 1.5           |     P=0.083N     P=0.307N     P=0.297N     P=0.119N    |P=0.453      P=0.238N     P=0.241N     P=0.686      | 
|POLY 6             |     P=0.081N     P=0.290N     P=0.274N     P=0.111N    |P=0.443      P=0.231N     P=0.237N     P=0.680      | 
|LOGISTIC REGRESSION|     P=0.078N     P=0.321N     P=0.255N     P=0.126N    |P=0.463      P=0.207N     P=0.201N     P=0.667N     | 
|COCH-ARM / FISHERS |     P=0.084N     P=0.316N     P=0.308N     P=0.125N    |P=0.457      P=0.247N     P=0.247N     P=0.692N     | 
|ORDER RESTRICTED   |     P=0.036N*    (e)          (e)          (e)         |P=0.257      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 19      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lacrimal Gland                                                                                                                   | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |3/10 (30%)   1/6 (17%)    0/8 (0%)     2/4 (50%)    | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       0/0.00       0/0.00      |3/10.00      1/6.00       0/8.00       2/4.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |30.0%        16.7%        0.0%         50.0%        | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |3/10 (30%)   1/6 (17%)    0/8 (0%)     2/4 (50%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.507      P=0.500N     P=0.151N     P=0.466      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.507      P=0.500N     P=0.138N     P=0.467      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.507      P=0.500N     P=0.138N     P=0.467      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.507      P=0.500N     P=0.138N     P=0.467      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.507      P=0.500N     (e)          P=0.466      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.507      P=0.511N     P=0.147N     P=0.455      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.197      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lacrimal Gland                                                                                                                   | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |10/10 (100%) 6/6 (100%)   8/8 (100%)   4/4 (100%)   | 
|POLY-3 RATE (b)    |     0/0.00       0/0.00       0/0.00       0/0.00      |10/10.00     6/6.00       8/8.00       4/4.00       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |100.0%       100.0%       100.0%       100.0%       | 
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |10/10 (100%) 6/6 (100%)   8/8 (100%)   4/4 (100%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 20      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/47 (4%)    0/48 (0%)    2/47 (4%)   |23/48 (48%)  30/48 (63%)  4/48 (8%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      2/42.48      0/43.02      2/42.52     |23/44.45     30/45.49     4/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.7%         0.0%         4.7%        |51.8%        66.0%        9.2%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    1/30 (3%)   |19/33 (58%)  25/36 (69%)  4/35 (11%)   1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          615          ---          707         |662          625          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.323      P=0.267      (e)          P=0.283     |P<0.001N**   P=0.230      P<0.001N**   P<0.001N**   | 
|POLY 3             |     P=0.301      P=0.243      (e)          P=0.243     |P<0.001N**   P=0.119      P<0.001N**   P<0.001N**   | 
|POLY 1.5           |     P=0.294      P=0.238      (e)          P=0.238     |P<0.001N**   P=0.104      P<0.001N**   P<0.001N**   | 
|POLY 6             |     P=0.314      P=0.252      (e)          P=0.251     |P<0.001N**   P=0.145      P<0.001N**   P<0.001N**   | 
|LOGISTIC REGRESSION|     P=0.285      P=0.223      (e)          P=0.253     |P<0.001N**   P=0.164      P<0.001N**   P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.287      P=0.242      (e)          P=0.242     |P<0.001N**   P=0.109      P<0.001N**   P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.121      (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/48 (8%)    18/47 (38%)  13/48 (27%)  19/47 (40%) |3/48 (6%)    2/48 (4%)    5/48 (10%)   3/48 (6%)    | 
|POLY-3 RATE (b)    |     4/41.95      18/43.47     13/43.84     19/43.58    |3/43.64      2/44.76      5/44.18      3/42.63      | 
|POLY-3 PERCENT (g) |     9.5%         41.4%        29.7%        43.6%       |6.9%         4.5%         11.3%        7.0%         | 
|TERMINAL (d)       |     2/24 (8%)    13/30 (43%)  11/34 (32%)  14/30 (47%) |3/33 (9%)    1/36 (3%)    3/35 (9%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     599          606          599          505         |734 (T)      714          657          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.026 *    P=0.004 **   P=0.066      P=0.003 **  |P=0.441      P=0.461N     P=0.394      P=0.650N     | 
|POLY 3             |     P=0.008 **   P<0.001 **   P=0.017 *    P<0.001 **  |P=0.425      P=0.488N     P=0.363      P=0.652      | 
|POLY 1.5           |     P=0.006 **   P<0.001 **   P=0.015 *    P<0.001 **  |P=0.436      P=0.498N     P=0.354      P=0.654      | 
|POLY 6             |     P=0.010 *    P<0.001 **   P=0.022 *    P<0.001 **  |P=0.416      P=0.475N     P=0.380      P=0.652      | 
|LOGISTIC REGRESSION|     P=0.009 **   P<0.001 **   P=0.019 *    P<0.001 **  |P=0.429      P=0.460N     P=0.355      P=0.650N     | 
|COCH-ARM / FISHERS |     P=0.007 **   P<0.001 **   P=0.015 *    P<0.001 **  |P=0.450      P=0.500N     P=0.357      P=0.661N     | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P=0.422      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 21      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Developmental Malformation                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/47 (2%)    0/48 (0%)    1/47 (2%)   |7/48 (15%)   5/48 (10%)   3/48 (6%)    5/48 (10%)   | 
|POLY-3 RATE (b)    |     1/41.93      1/42.44      0/43.02      1/43.09     |7/44.55      5/45.35      3/43.67      5/43.49      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         0.0%         2.3%        |15.7%        11.0%        6.9%         11.5%        | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |2/33 (6%)    3/36 (8%)    3/35 (9%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     564          629          ---          505         |662          625          734 (T)      585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.596N     P=0.758      P=0.513N     P=0.751     |P=0.340N     P=0.335N     P=0.148N     P=0.389N     | 
|POLY 3             |     P=0.599N     P=0.758N     P=0.495N     P=0.755N    |P=0.341N     P=0.366N     P=0.165N     P=0.396N     | 
|POLY 1.5           |     P=0.601N     P=0.759      P=0.498N     P=0.759N    |P=0.333N     P=0.378N     P=0.166N     P=0.391N     | 
|POLY 6             |     P=0.596N     P=0.751N     P=0.487N     P=0.747N    |P=0.349N     P=0.351N     P=0.162N     P=0.399N     | 
|LOGISTIC REGRESSION|     P=0.570N     P=0.771N     P=0.376N     P=0.692N    |P=0.318N     P=0.374N     P=0.160N     P=0.358N     | 
|COCH-ARM / FISHERS |     P=0.603N     P=0.747      P=0.500N     P=0.747     |P=0.321N     P=0.379N     P=0.158N     P=0.379N     | 
|ORDER RESTRICTED   |     P=0.527N     (e)          (e)          (e)         |P=0.267N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Eosinophilic Focus                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    14/47 (30%)  19/48 (40%)  33/47 (70%) |3/48 (6%)    12/48 (25%)  20/48 (42%)  16/48 (33%)  | 
|POLY-3 RATE (b)    |     3/41.39      14/42.52     19/43.16     33/44.83    |3/43.64      12/45.16     20/44.10     16/42.63     | 
|POLY-3 PERCENT (g) |     7.3%         32.9%        44.0%        73.6%       |6.9%         26.6%        45.4%        37.5%        | 
|TERMINAL (d)       |     3/24 (13%)   12/30 (40%)  18/34 (53%)  23/30 (77%) |3/33 (9%)    10/36 (28%)  18/35 (51%)  16/34 (47%)  | 
|FIRST INCIDENCE    |     733 (T)      604          698          475         |734 (T)      605          657          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 **  |P=0.002 **   P=0.020 *    P<0.001 **   P<0.001 **   | 
|POLY 3             |     P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.012 *    P<0.001 **   P<0.001 **   | 
|POLY 1.5           |     P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 **   | 
|POLY 6             |     P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P<0.001 **   P=0.006 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.015 *    P<0.001 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P<0.001 **   P=0.003 **   P<0.001 **   P<0.001 **  |P=0.003 **   P=0.011 *    P<0.001 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P<0.001 **   (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 22      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    1/48 (2%)    3/48 (6%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      0/43.02      0/42.42     |1/43.64      1/44.68      3/43.67      1/42.87      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         0.0%        |2.3%         2.2%         6.9%         2.3%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    1/36 (3%)    3/35 (9%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          ---         |734 (T)      734 (T)      734 (T)      669          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.304N     P=0.455N     P=0.431N     P=0.455N    |P=0.532      P=0.742N     P=0.326      P=0.760N     | 
|POLY 3             |     P=0.338N     P=0.497N     P=0.492N     P=0.495N    |P=0.519      P=0.755N     P=0.305      P=0.757      | 
|POLY 1.5           |     P=0.335N     P=0.500N     P=0.497N     P=0.499N    |P=0.526      P=0.760N     P=0.302      P=0.757      | 
|POLY 6             |     P=0.343N     P=0.490N     P=0.483N     P=0.488N    |P=0.515      P=0.749N     P=0.313      P=0.758      | 
|LOGISTIC REGRESSION|     P=0.304N     (e)          (e)          (e)         |P=0.521      P=0.742N     P=0.326      P=0.762N     | 
|COCH-ARM / FISHERS |     P=0.331N     P=0.505N     P=0.500N     P=0.505N    |P=0.535      P=0.753N     P=0.308      P=0.753N     | 
|ORDER RESTRICTED   |     P=0.115N     (e)          (e)          (e)         |P=0.436      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    2/47 (4%)    3/48 (6%)    0/47 (0%)   |4/48 (8%)    1/48 (2%)    5/48 (10%)   1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/41.39      2/42.48      3/43.14      0/42.42     |4/44.14      1/44.68      5/44.47      1/42.99      | 
|POLY-3 PERCENT (g) |     4.8%         4.7%         7.0%         0.0%        |9.1%         2.2%         11.2%        2.3%         | 
|TERMINAL (d)       |     2/24 (8%)    1/30 (3%)    2/34 (6%)    0/30 (0%)   |2/33 (6%)    1/36 (3%)    2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      615          703          ---         |662          734 (T)      599          633          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.160N     P=0.631N     P=0.643      P=0.190N    |P=0.309N     P=0.158N     P=0.533      P=0.189N     | 
|POLY 3             |     P=0.193N     P=0.685N     P=0.519      P=0.231N    |P=0.311N     P=0.175N     P=0.505      P=0.186N     | 
|POLY 1.5           |     P=0.198N     P=0.693N     P=0.508      P=0.236N    |P=0.303N     P=0.179N     P=0.496      P=0.184N     | 
|POLY 6             |     P=0.185N     P=0.671N     P=0.542      P=0.224N    |P=0.319N     P=0.169N     P=0.521      P=0.187N     | 
|LOGISTIC REGRESSION|     P=0.193N     P=0.695      P=0.578      (e)         |P=0.288N     P=0.179N     P=0.510      P=0.162N     | 
|COCH-ARM / FISHERS |     P=0.204N     P=0.684      P=0.500      P=0.253N    |P=0.294N     P=0.181N     P=0.500      P=0.181N     | 
|ORDER RESTRICTED   |     P=0.160N     (e)          (e)          (e)         |P=0.150N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 23      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    1/47 (2%)   |2/48 (4%)    3/48 (6%)    7/48 (15%)   4/48 (8%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      1/42.42     |2/43.64      3/44.69      7/43.67      4/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.4%        |4.6%         6.7%         16.0%        9.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |2/33 (6%)    2/36 (6%)    7/35 (20%)   4/34 (12%)   | 
|FIRST INCIDENCE    |     ---          ---          ---          733 (T)     |734 (T)      732          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.203      (e)          (e)          P=0.545     |P=0.226      P=0.542      P=0.092      P=0.350      | 
|POLY 3             |     P=0.193      (e)          (e)          P=0.505     |P=0.207      P=0.511      P=0.078      P=0.326      | 
|POLY 1.5           |     P=0.192      (e)          (e)          P=0.501     |P=0.216      P=0.502      P=0.076      P=0.329      | 
|POLY 6             |     P=0.196      (e)          (e)          P=0.512     |P=0.199      P=0.524      P=0.083      P=0.325      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.545     |P=0.226      P=0.550      P=0.092      P=0.350      | 
|COCH-ARM / FISHERS |     P=0.189      (e)          (e)          P=0.495     |P=0.229      P=0.500      P=0.079      P=0.339      | 
|ORDER RESTRICTED   |     P=0.125      (e)          (e)          (e)         |P=0.147      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Granulomatous Focal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    1/47 (2%)    1/48 (2%)    1/47 (2%)   |10/48 (21%)  19/48 (40%)  20/48 (42%)  13/48 (27%)  | 
|POLY-3 RATE (b)    |     3/41.39      1/42.07      1/43.28      1/42.42     |10/43.97     19/46.62     20/43.93     13/42.85     | 
|POLY-3 PERCENT (g) |     7.3%         2.4%         2.3%         2.4%        |22.7%        40.8%        45.5%        30.3%        | 
|TERMINAL (d)       |     3/24 (13%)   1/30 (3%)    0/34 (0%)    1/30 (3%)   |8/33 (24%)   15/36 (42%)  17/35 (49%)  12/34 (35%)  | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      662          733 (T)     |662          60           709          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.215N     P=0.227N     P=0.209N     P=0.227N    |P=0.475      P=0.070      P=0.038 *    P=0.339      | 
|POLY 3             |     P=0.262N     P=0.299N     P=0.289N     P=0.296N    |P=0.408      P=0.051      P=0.018 *    P=0.288      | 
|POLY 1.5           |     P=0.265N     P=0.306N     P=0.299N     P=0.304N    |P=0.434      P=0.044 *    P=0.018 *    P=0.297      | 
|POLY 6             |     P=0.259N     P=0.287N     P=0.270N     P=0.283N    |P=0.387      P=0.063      P=0.021 *    P=0.283      | 
|LOGISTIC REGRESSION|     P=0.244N     P=0.227N     P=0.280N     P=0.227N    |P=0.453      P=0.038 *    P=0.029 *    P=0.294      | 
|COCH-ARM / FISHERS |     P=0.266N     P=0.316N     P=0.308N     P=0.316N    |P=0.485      P=0.037 *    P=0.023 *    P=0.317      | 
|ORDER RESTRICTED   |     P=0.176N     (e)          (e)          (e)         |P=0.083      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 24      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/48 (0%)    2/47 (4%)   |1/48 (2%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.77      0/42.07      0/43.02      2/42.42     |1/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         4.7%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     623          ---          ---          733 (T)     |734 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.250      P=0.505N     P=0.490N     P=0.560     |P=0.329N     P=0.483N     P=0.488N     P=0.494N     | 
|POLY 3             |     P=0.222      P=0.499N     P=0.494N     P=0.505     |P=0.331N     P=0.495N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.221      P=0.501N     P=0.498N     P=0.499     |P=0.330N     P=0.499N     P=0.502N     P=0.503N     | 
|POLY 6             |     P=0.223      P=0.493N     P=0.486N     P=0.515     |P=0.333N     P=0.490N     P=0.495N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.219      P=0.506N     P=0.464N     P=0.490     |P=0.329N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.221      P=0.505N     P=0.500N     P=0.492     |P=0.330N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.134      (e)          (e)          (e)         |P=0.125N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    1/48 (2%)    0/47 (0%)   |4/48 (8%)    2/48 (4%)    1/48 (2%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      1/43.02      0/42.42     |4/44.16      2/44.72      1/43.67      3/43.24      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         2.3%         0.0%        |9.1%         4.5%         2.3%         6.9%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |3/33 (9%)    1/36 (3%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          733 (T)      ---         |578          725          734 (T)      536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.401N     P=0.455N     P=0.682N     P=0.455N    |P=0.476N     P=0.304N     P=0.170N     P=0.497N     | 
|POLY 3             |     P=0.439N     P=0.497N     P=0.752N     P=0.495N    |P=0.481N     P=0.331N     P=0.182N     P=0.511N     | 
|POLY 1.5           |     P=0.440N     P=0.500N     P=0.757N     P=0.499N    |P=0.477N     P=0.338N     P=0.184N     P=0.508N     | 
|POLY 6             |     P=0.438N     P=0.490N     P=0.741N     P=0.488N    |P=0.485N     P=0.320N     P=0.176N     P=0.511N     | 
|LOGISTIC REGRESSION|     P=0.401N     (e)          P=0.682N     (e)         |P=0.468N     P=0.337N     P=0.178N     P=0.466N     | 
|COCH-ARM / FISHERS |     P=0.440N     P=0.505N     P=0.753N     P=0.505N    |P=0.471N     P=0.339N     P=0.181N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.246N     (e)          (e)          (e)         |P=0.291N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 25      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Tension Lipidosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |1/48 (2%)    2/48 (4%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |1/43.64      2/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |2.3%         4.5%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |1/33 (3%)    2/36 (6%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.455N     P=0.530      P=0.488N     P=0.755N     | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.459N     P=0.508      P=0.500N     P=0.755      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.459N     P=0.501      P=0.502N     P=0.757      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.456N     P=0.518      P=0.495N     P=0.756      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.455N     P=0.530      (e)          P=0.755N     | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.456N     P=0.500      P=0.500N     P=0.753N     | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.391N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     9/48 (19%)   21/47 (45%)  10/48 (21%)  13/47 (28%) |5/48 (10%)   5/48 (10%)   17/48 (35%)  22/48 (46%)  | 
|POLY-3 RATE (b)    |     9/41.98      21/42.51     10/43.16     13/42.70    |5/44.45      5/44.76      17/44.13     22/42.85     | 
|POLY-3 PERCENT (g) |     21.4%        49.4%        23.2%        30.5%       |11.3%        11.2%        38.5%        51.3%        | 
|TERMINAL (d)       |     5/24 (21%)   18/30 (60%)  9/34 (27%)   11/30 (37%) |2/33 (6%)    4/36 (11%)   16/35 (46%)  21/34 (62%)  | 
|FIRST INCIDENCE    |     613          620          698          687         |589          716          599          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.261N     P=0.038 *    P=0.413N     P=0.413     |P<0.001 **   P=0.580N     P=0.006 **   P<0.001 **   | 
|POLY 3             |     P=0.410N     P=0.005 **   P=0.527      P=0.241     |P<0.001 **   P=0.626N     P=0.002 **   P<0.001 **   | 
|POLY 1.5           |     P=0.435N     P=0.005 **   P=0.509      P=0.229     |P<0.001 **   P=0.627      P=0.002 **   P<0.001 **   | 
|POLY 6             |     P=0.369N     P=0.005 **   P=0.566      P=0.264     |P<0.001 **   P=0.616N     P=0.002 **   P<0.001 **   | 
|LOGISTIC REGRESSION|     P=0.344N     P=0.011 *    P=0.593N     P=0.304     |P<0.001 **   P=0.631      P=0.004 **   P<0.001 **   | 
|COCH-ARM / FISHERS |     P=0.460N     P=0.006 **   P=0.500      P=0.216     |P<0.001 **   P=0.630N     P=0.003 **   P<0.001 **   | 
|ORDER RESTRICTED   |     P=0.147      (e)          (e)          (e)         |P<0.001 **   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 26      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    1/48 (2%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    2/48 (4%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      1/43.02      0/42.42     |0/43.64      0/44.68      2/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         2.3%         0.0%        |0.0%         0.0%         4.6%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          733 (T)      ---         |---          ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.401N     P=0.455N     P=0.682N     P=0.455N    |P=0.561      (e)          P=0.251      (e)          | 
|POLY 3             |     P=0.439N     P=0.497N     P=0.752N     P=0.495N    |P=0.542      (e)          P=0.237      (e)          | 
|POLY 1.5           |     P=0.440N     P=0.500N     P=0.757N     P=0.499N    |P=0.551      (e)          P=0.235      (e)          | 
|POLY 6             |     P=0.438N     P=0.490N     P=0.741N     P=0.488N    |P=0.534      (e)          P=0.242      (e)          | 
|LOGISTIC REGRESSION|     P=0.401N     (e)          P=0.682N     (e)         |(e)          (e)          P=0.251      (e)          | 
|COCH-ARM / FISHERS |     P=0.440N     P=0.505N     P=0.753N     P=0.505N    |P=0.561      (e)          P=0.247      (e)          | 
|ORDER RESTRICTED   |     P=0.246N     (e)          (e)          (e)         |P=0.247      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     41/48 (85%)  42/47 (89%)  42/48 (88%)  38/47 (81%) |16/48 (33%)  18/48 (38%)  19/48 (40%)  18/48 (38%)  | 
|POLY-3 RATE (b)    |     41/46.16     42/45.93     42/46.42     38/44.63    |16/44.57     18/45.42     19/44.27     18/43.16     | 
|POLY-3 PERCENT (g) |     88.8%        91.5%        90.5%        85.1%       |35.9%        39.6%        42.9%        41.7%        | 
|TERMINAL (d)       |     22/24 (92%)  29/30 (97%)  33/34 (97%)  29/30 (97%) |12/33 (36%)  15/36 (42%)  17/35 (49%)  17/34 (50%)  | 
|FIRST INCIDENCE    |     541          487          435          601         |552          605          599          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.042N*    P=0.198N     P=0.050N     P=0.054N    |P=0.386      P=0.537      P=0.416      P=0.448      | 
|POLY 3             |     P=0.263N     P=0.468      P=0.534      P=0.410N    |P=0.328      P=0.441      P=0.322      P=0.367      | 
|POLY 1.5           |     P=0.253N     P=0.431      P=0.503      P=0.401N    |P=0.356      P=0.417      P=0.314      P=0.383      | 
|POLY 6             |     P=0.260N     P=0.535      P=0.621      P=0.407N    |P=0.302      P=0.480      P=0.344      P=0.354      | 
|LOGISTIC REGRESSION|     P=0.175N     P=0.436      P=0.491      P=0.247N    |P=0.333      P=0.444      P=0.344      P=0.377      | 
|COCH-ARM / FISHERS |     P=0.226N     P=0.395      P=0.500      P=0.375N    |P=0.397      P=0.416      P=0.336      P=0.416      | 
|ORDER RESTRICTED   |     P=0.318N     (e)          (e)          (e)         |P=0.427      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 27      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Centrilobular                                                                                                             | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    1/48 (2%)    3/47 (6%)   |0/48 (0%)    0/48 (0%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.07      1/43.81      3/43.50     |0/43.64      0/44.68      1/43.77      2/43.23      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         2.3%         6.9%        |0.0%         0.0%         2.3%         4.6%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      439          505         |---          ---          709          633          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.065      P=0.545      P=0.496      P=0.134     |P=0.058      (e)          P=0.516      P=0.234      | 
|POLY 3             |     P=0.062      P=0.503      P=0.511      P=0.127     |P=0.061      (e)          P=0.501      P=0.235      | 
|POLY 1.5           |     P=0.059      P=0.500      P=0.505      P=0.122     |P=0.062      (e)          P=0.498      P=0.235      | 
|POLY 6             |     P=0.067      P=0.510      P=0.522      P=0.137     |P=0.061      (e)          P=0.505      P=0.237      | 
|LOGISTIC REGRESSION|     P=0.045 *    P=0.545      (e)          P=0.100     |P=0.064      (e)          P=0.499      P=0.276      | 
|COCH-ARM / FISHERS |     P=0.055      P=0.495      P=0.500      P=0.117     |P=0.064      (e)          P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     P=0.042 *    (e)          (e)          (e)         |P=0.073      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    2/48 (4%)    0/47 (0%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.51      0/42.07      2/43.31      0/42.42     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         4.6%         0.0%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     701          ---          668          ---         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.477N     P=0.476N     P=0.578      P=0.482N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.496N     P=0.497N     P=0.515      P=0.496N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.499N     P=0.501N     P=0.506      P=0.500N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.492N     P=0.491N     P=0.532      P=0.489N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.505N     P=0.502N     P=0.500      P=0.503N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.503N     P=0.505N     P=0.500      P=0.505N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.321N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 28      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    2/47 (4%)    4/48 (8%)    6/47 (13%)  |0/48 (0%)    3/48 (6%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     2/41.99      2/42.07      4/43.02      6/42.74     |0/43.64      3/44.69      1/43.67      2/43.24      | 
|POLY-3 PERCENT (g) |     4.8%         4.8%         9.3%         14.0%       |0.0%         6.7%         2.3%         4.6%         | 
|TERMINAL (d)       |     1/24 (4%)    2/30 (7%)    4/34 (12%)   5/30 (17%)  |0/33 (0%)    2/36 (6%)    1/35 (3%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     541          733 (T)      733 (T)      645         |---          732          734 (T)      536          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.074      P=0.637N     P=0.471      P=0.199     |P=0.391      P=0.141      P=0.512      P=0.238      | 
|POLY 3             |     P=0.053      P=0.694N     P=0.348      P=0.137     |P=0.389      P=0.123      P=0.500      P=0.235      | 
|POLY 1.5           |     P=0.051      P=0.690      P=0.340      P=0.132     |P=0.388      P=0.119      P=0.498      P=0.235      | 
|POLY 6             |     P=0.057      P=0.685N     P=0.367      P=0.147     |P=0.393      P=0.128      P=0.505      P=0.236      | 
|LOGISTIC REGRESSION|     P=0.054      P=0.678      P=0.340      P=0.125     |P=0.393      P=0.139      P=0.512      P=0.294      | 
|COCH-ARM / FISHERS |     P=0.049 *    P=0.684      P=0.339      P=0.127     |P=0.392      P=0.121      P=0.500      P=0.247      | 
|ORDER RESTRICTED   |     P=0.091      (e)          (e)          (e)         |P=0.185      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolus                                                                                                                   | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    4/47 (9%)    2/48 (4%)    4/47 (9%)   |4/48 (8%)    3/48 (6%)    10/48 (21%)  6/48 (13%)   | 
|POLY-3 RATE (b)    |     3/41.77      4/42.12      2/43.02      4/42.48     |4/44.39      3/44.68      10/43.93     6/43.28      | 
|POLY-3 PERCENT (g) |     7.2%         9.5%         4.7%         9.4%        |9.0%         6.7%         22.8%        13.9%        | 
|TERMINAL (d)       |     2/24 (8%)    2/30 (7%)    2/34 (6%)    3/30 (10%)  |2/33 (6%)    3/36 (8%)    8/35 (23%)   4/34 (12%)   | 
|FIRST INCIDENCE    |     623          724          733 (T)      717         |589          734 (T)      676          633          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.573N     P=0.601      P=0.371N     P=0.599     |P=0.162      P=0.461N     P=0.099      P=0.372      | 
|POLY 3             |     P=0.510      P=0.505      P=0.487N     P=0.509     |P=0.145      P=0.496N     P=0.068      P=0.353      | 
|POLY 1.5           |     P=0.502      P=0.496      P=0.495N     P=0.499     |P=0.153      P=0.503N     P=0.067      P=0.358      | 
|POLY 6             |     P=0.524      P=0.520      P=0.468N     P=0.525     |P=0.139      P=0.487N     P=0.071      P=0.353      | 
|LOGISTIC REGRESSION|     P=0.535      P=0.523      P=0.481N     P=0.527     |P=0.156      P=0.499N     P=0.072      P=0.384      | 
|COCH-ARM / FISHERS |     P=0.493      P=0.488      P=0.500N     P=0.488     |P=0.166      P=0.500N     P=0.073      P=0.370      | 
|ORDER RESTRICTED   |     P=0.541      (e)          (e)          (e)         |P=0.108      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 29      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    1/46 (2%)    2/48 (4%)    0/47 (0%)   |1/46 (2%)    0/46 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.39      1/41.48      2/43.07      0/42.42     |1/42.22      0/42.97      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         4.6%         0.0%        |2.4%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     2/24 (8%)    1/30 (3%)    1/34 (3%)    0/30 (0%)   |1/32 (3%)    0/35 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      722          ---         |734 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.174N     P=0.422N     P=0.569N     P=0.190N    |P=0.325N     P=0.482N     P=0.482N     P=0.488N     | 
|POLY 3             |     P=0.209N     P=0.499N     P=0.680N     P=0.231N    |P=0.324N     P=0.496N     P=0.493N     P=0.498N     | 
|POLY 1.5           |     P=0.212N     P=0.507N     P=0.688N     P=0.236N    |P=0.323N     P=0.500N     P=0.495N     P=0.496N     | 
|POLY 6             |     P=0.205N     P=0.486N     P=0.662N     P=0.224N    |P=0.326N     P=0.491N     P=0.490N     P=0.499N     | 
|LOGISTIC REGRESSION|     P=0.189N     P=0.422N     P=0.618N     (e)         |P=0.325N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.215N     P=0.516N     P=0.692N     P=0.253N    |P=0.324N     P=0.500N     P=0.489N     P=0.489N     | 
|ORDER RESTRICTED   |     P=0.151N     (e)          (e)          (e)         |P=0.118N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mandibular                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    5/46 (11%)   6/48 (13%)   4/47 (9%)   |0/46 (0%)    0/46 (0%)    2/48 (4%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     3/41.39      5/41.48      6/43.16      4/42.48     |0/42.22      0/42.97      2/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     7.3%         12.1%        13.9%        9.4%        |0.0%         0.0%         4.6%         4.7%         | 
|TERMINAL (d)       |     3/24 (13%)   5/30 (17%)   5/34 (15%)   3/30 (10%)  |0/32 (0%)    0/35 (0%)    2/35 (6%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      698          717         |---          ---          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.548N     P=0.483      P=0.426      P=0.612     |P=0.078      (e)          P=0.258      P=0.252      | 
|POLY 3             |     P=0.506      P=0.357      P=0.262      P=0.514     |P=0.074      (e)          P=0.245      P=0.239      | 
|POLY 1.5           |     P=0.492      P=0.345      P=0.250      P=0.502     |P=0.077      (e)          P=0.243      P=0.241      | 
|POLY 6             |     P=0.529      P=0.378      P=0.288      P=0.534     |P=0.071      (e)          P=0.249      P=0.238      | 
|LOGISTIC REGRESSION|     P=0.534      P=0.483      P=0.343      P=0.570     |(e)          (e)          P=0.258      P=0.252      | 
|COCH-ARM / FISHERS |     P=0.476      P=0.333      P=0.243      P=0.488     |P=0.082      (e)          P=0.258      P=0.258      | 
|ORDER RESTRICTED   |     P=0.398      (e)          (e)          (e)         |P=0.117      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 30      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/46 (4%)    3/48 (6%)    1/47 (2%)   |1/46 (2%)    1/46 (2%)    4/48 (8%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      2/41.48      3/43.07      1/42.42     |1/42.22      1/43.97      4/44.39      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         7.0%         2.4%        |2.4%         2.3%         9.0%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    2/34 (6%)    1/30 (3%)   |1/32 (3%)    0/35 (0%)    3/35 (9%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          732          722          733 (T)     |734 (T)      60           482          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.517      P=0.289      P=0.187      P=0.545     |P=0.508      P=0.750N     P=0.200      P=0.748N     | 
|POLY 3             |     P=0.486      P=0.237      P=0.125      P=0.505     |P=0.486      P=0.751N     P=0.194      P=0.759N     | 
|POLY 1.5           |     P=0.475      P=0.233      P=0.121      P=0.501     |P=0.498      P=0.756N     P=0.190      P=0.756N     | 
|POLY 6             |     P=0.504      P=0.246      P=0.135      P=0.512     |P=0.474      P=0.745N     P=0.201      P=0.760N     | 
|LOGISTIC REGRESSION|     P=0.494      P=0.282      P=0.155      P=0.545     |P=0.539      P=0.563N     P=0.204      P=0.748N     | 
|COCH-ARM / FISHERS |     P=0.462      P=0.237      P=0.121      P=0.495     |P=0.519      P=0.753N     P=0.194      P=0.742N     | 
|ORDER RESTRICTED   |     P=0.190      (e)          (e)          (e)         |P=0.339      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mandibular                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/48 (10%)   6/46 (13%)   11/48 (23%)  7/47 (15%)  |4/46 (9%)    8/46 (17%)   4/48 (8%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     5/41.49      6/41.88      11/43.32     7/42.62     |4/42.51      8/43.97      4/44.17      0/42.63      | 
|POLY-3 PERCENT (g) |     12.1%        14.3%        25.4%        16.4%       |9.4%         18.2%        9.1%         0.0%         | 
|TERMINAL (d)       |     4/24 (17%)   3/30 (10%)   10/34 (29%)  6/30 (20%)  |3/32 (9%)    7/35 (20%)   2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     706          667          652          679         |653          60           599          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.386      P=0.611N     P=0.244      P=0.529     |P=0.017N*    P=0.219      P=0.601N     P=0.061N     | 
|POLY 3             |     P=0.292      P=0.507      P=0.096      P=0.397     |P=0.016N*    P=0.192      P=0.622N     P=0.059N     | 
|POLY 1.5           |     P=0.279      P=0.489      P=0.088      P=0.381     |P=0.015N*    P=0.185      P=0.627N     P=0.058N     | 
|POLY 6             |     P=0.312      P=0.538      P=0.115      P=0.423     |P=0.017N*    P=0.203      P=0.611N     P=0.060N     | 
|LOGISTIC REGRESSION|     P=0.317      P=0.544      P=0.144      P=0.455     |P=0.013N*    P=0.199      P=0.622N     P=0.060N     | 
|COCH-ARM / FISHERS |     P=0.266      P=0.470      P=0.085      P=0.364     |P=0.015N*    P=0.177      P=0.619N     P=0.054N     | 
|ORDER RESTRICTED   |     P=0.218      (e)          (e)          (e)         |P=0.017N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 31      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/46 (2%)    1/48 (2%)    1/47 (2%)   |1/46 (2%)    3/46 (7%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/41.51      1/43.07      1/42.42     |1/42.22      3/42.97      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         2.3%         2.4%        |2.4%         7.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |1/32 (3%)    3/35 (9%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          724          722          733 (T)     |734 (T)      734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.424      P=0.546      P=0.557      P=0.545     |P=0.334N     P=0.337      P=0.482N     P=0.748N     | 
|POLY 3             |     P=0.414      P=0.501      P=0.508      P=0.505     |P=0.336N     P=0.311      P=0.493N     P=0.759N     | 
|POLY 1.5           |     P=0.407      P=0.496      P=0.503      P=0.501     |P=0.336N     P=0.305      P=0.495N     P=0.756N     | 
|POLY 6             |     P=0.426      P=0.509      P=0.518      P=0.512     |P=0.334N     P=0.321      P=0.490N     P=0.760N     | 
|LOGISTIC REGRESSION|     P=0.418      P=0.517      P=0.524      P=0.545     |P=0.334N     P=0.337      (e)          P=0.748N     | 
|COCH-ARM / FISHERS |     P=0.398      P=0.489      P=0.500      P=0.495     |P=0.331N     P=0.308      P=0.489N     P=0.742N     | 
|ORDER RESTRICTED   |     P=0.331      (e)          (e)          (e)         |P=0.266N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     4/48 (8%)    6/46 (13%)   6/48 (13%)   1/47 (2%)   |2/46 (4%)    1/46 (2%)    4/48 (8%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     4/41.69      6/41.85      6/43.45      1/42.42     |2/42.22      1/42.97      4/43.89      2/42.63      | 
|POLY-3 PERCENT (g) |     9.6%         14.3%        13.8%        2.4%        |4.7%         2.3%         9.1%         4.7%         | 
|TERMINAL (d)       |     2/24 (8%)    3/30 (10%)   4/34 (12%)   1/30 (3%)   |2/32 (6%)    1/35 (3%)    3/35 (9%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     659          667          652          733 (T)     |734 (T)      734 (T)      676          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.076N     P=0.493      P=0.546      P=0.134N    |P=0.452      P=0.469N     P=0.382      P=0.674N     | 
|POLY 3             |     P=0.099N     P=0.371      P=0.395      P=0.173N    |P=0.437      P=0.494N     P=0.355      P=0.691N     | 
|POLY 1.5           |     P=0.105N     P=0.357      P=0.380      P=0.179N    |P=0.448      P=0.500N     P=0.351      P=0.687N     | 
|POLY 6             |     P=0.091N     P=0.396      P=0.427      P=0.163N    |P=0.425      P=0.484N     P=0.365      P=0.692N     | 
|LOGISTIC REGRESSION|     P=0.099N     P=0.384      P=0.401      P=0.160N    |P=0.436      P=0.469N     P=0.360      P=0.674N     | 
|COCH-ARM / FISHERS |     P=0.112N     P=0.343      P=0.370      P=0.187N    |P=0.463      P=0.500N     P=0.359      P=0.675N     | 
|ORDER RESTRICTED   |     P=0.089N     (e)          (e)          (e)         |P=0.385      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 32      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    3/46 (7%)    2/48 (4%)    1/47 (2%)   |0/46 (0%)    1/46 (2%)    0/48 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     1/41.39      3/41.84      2/43.66      1/42.59     |0/42.22      1/42.97      0/43.67      2/42.64      | 
|POLY-3 PERCENT (g) |     2.4%         7.2%         4.6%         2.4%        |0.0%         2.3%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    2/30 (7%)    0/34 (0%)    0/30 (0%)   |0/32 (0%)    1/35 (3%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     732          629          543          687         |---          734 (T)      ---          733          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.396N     P=0.368      P=0.563      P=0.730N    |P=0.160      P=0.518      (e)          P=0.253      | 
|POLY 3             |     P=0.414N     P=0.309      P=0.519      P=0.754N    |P=0.158      P=0.504      (e)          P=0.239      | 
|POLY 1.5           |     P=0.424N     P=0.300      P=0.508      P=0.760N    |P=0.159      P=0.500      (e)          P=0.242      | 
|POLY 6             |     P=0.397N     P=0.325      P=0.538      P=0.746N    |P=0.157      P=0.509      (e)          P=0.238      | 
|LOGISTIC REGRESSION|     P=0.444N     P=0.299      P=0.506      P=0.759N    |P=0.157      P=0.518      (e)          P=0.249      | 
|COCH-ARM / FISHERS |     P=0.435N     P=0.292      P=0.500      P=0.747     |P=0.163      P=0.500      (e)          P=0.258      | 
|ORDER RESTRICTED   |     P=0.455N     (e)          (e)          (e)         |P=0.075      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/46 (0%)    1/48 (2%)    1/47 (2%)   |1/46 (2%)    0/46 (0%)    2/48 (4%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     1/41.52      0/41.48      1/43.02      1/42.42     |1/42.22      0/42.97      2/43.89      2/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         2.3%         2.4%        |2.4%         0.0%         4.6%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    1/30 (3%)   |1/32 (3%)    0/35 (0%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     698          ---          733 (T)      733 (T)     |734 (T)      ---          676          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.537      P=0.482N     P=0.699N     P=0.725N    |P=0.217      P=0.482N     P=0.535      P=0.521      | 
|POLY 3             |     P=0.505      P=0.500N     P=0.753N     P=0.756N    |P=0.213      P=0.496N     P=0.514      P=0.503      | 
|POLY 1.5           |     P=0.502      P=0.504N     P=0.758N     P=0.760N    |P=0.220      P=0.500N     P=0.510      P=0.507      | 
|POLY 6             |     P=0.507      P=0.493N     P=0.743N     P=0.749N    |P=0.206      P=0.491N     P=0.521      P=0.502      | 
|LOGISTIC REGRESSION|     P=0.516      P=0.509N     P=0.750N     P=0.752N    |P=0.213      (e)          P=0.511      P=0.521      | 
|COCH-ARM / FISHERS |     P=0.499      P=0.511N     P=0.753N     P=0.747     |P=0.227      P=0.500N     P=0.516      P=0.516      | 
|ORDER RESTRICTED   |     P=0.543      (e)          (e)          (e)         |P=0.270      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 33      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    0/46 (0%)    0/48 (0%)    1/47 (2%)   |0/46 (0%)    0/46 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.51      0/41.48      0/43.02      1/42.74     |0/42.22      0/42.97      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         0.0%         0.0%         2.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/32 (0%)    0/35 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     701          ---          ---          645         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.464N     P=0.203N     P=0.181N     P=0.447N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.506N     P=0.237N     P=0.229N     P=0.490N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.503N     P=0.242N     P=0.234N     P=0.498N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.510N     P=0.229N     P=0.219N     P=0.477N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.503N     P=0.227N     P=0.218N     P=0.514N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.500N     P=0.258N     P=0.247N     P=0.508N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.124N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Pancreatic                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/46 (2%)    0/48 (0%)    0/47 (0%)   |0/46 (0%)    1/46 (2%)    2/48 (4%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     1/41.39      1/41.48      0/43.02      0/42.42     |0/42.22      1/42.97      2/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         0.0%         0.0%        |0.0%         2.3%         4.6%         2.4%         | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/32 (0%)    1/35 (3%)    2/35 (6%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      ---          ---         |---          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.188N     P=0.712N     P=0.431N     P=0.455N    |P=0.379      P=0.518      P=0.258      P=0.512      | 
|POLY 3             |     P=0.217N     P=0.760N     P=0.492N     P=0.495N    |P=0.366      P=0.504      P=0.245      P=0.502      | 
|POLY 1.5           |     P=0.219N     P=0.756      P=0.497N     P=0.499N    |P=0.373      P=0.500      P=0.243      P=0.504      | 
|POLY 6             |     P=0.214N     P=0.752N     P=0.483N     P=0.488N    |P=0.360      P=0.509      P=0.249      P=0.501      | 
|LOGISTIC REGRESSION|     P=0.188N     P=0.712N     (e)          (e)         |(e)          P=0.518      P=0.258      P=0.512      | 
|COCH-ARM / FISHERS |     P=0.219N     P=0.742      P=0.500N     P=0.505N    |P=0.384      P=0.500      P=0.258      P=0.511      | 
|ORDER RESTRICTED   |     P=0.246N     (e)          (e)          (e)         |P=0.233      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 34      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/46 (4%)    0/48 (0%)    0/47 (0%)   |1/46 (2%)    0/46 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.39      2/41.49      0/43.02      0/42.42     |1/42.22      0/42.97      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         4.8%         0.0%         0.0%        |2.4%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |1/32 (3%)    0/35 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     732          729          ---          ---         |734 (T)      ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.133N     P=0.578      P=0.439N     P=0.464N    |P=0.325N     P=0.482N     P=0.482N     P=0.488N     | 
|POLY 3             |     P=0.149N     P=0.501      P=0.492N     P=0.495N    |P=0.324N     P=0.496N     P=0.493N     P=0.498N     | 
|POLY 1.5           |     P=0.152N     P=0.493      P=0.497N     P=0.500N    |P=0.323N     P=0.500N     P=0.495N     P=0.496N     | 
|POLY 6             |     P=0.143N     P=0.515      P=0.483N     P=0.488N    |P=0.326N     P=0.491N     P=0.490N     P=0.499N     | 
|LOGISTIC REGRESSION|     P=0.137N     P=0.561      P=0.450N     P=0.473N    |P=0.325N     (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.155N     P=0.484      P=0.500N     P=0.505N    |P=0.324N     P=0.500N     P=0.489N     P=0.489N     | 
|ORDER RESTRICTED   |     P=0.164N     (e)          (e)          (e)         |P=0.118N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    2/46 (4%)    0/48 (0%)    0/47 (0%)   |2/46 (4%)    0/46 (0%)    1/48 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      2/41.49      0/43.02      0/42.42     |2/42.22      0/42.97      1/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.8%         0.0%         0.0%        |4.7%         0.0%         2.3%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |2/32 (6%)    0/35 (0%)    1/35 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          729          ---          ---         |734 (T)      ---          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.295N     P=0.292      (e)          (e)         |P=0.214N     P=0.219N     P=0.469N     P=0.225N     | 
|POLY 3             |     P=0.306N     P=0.237      (e)          (e)         |P=0.221N     P=0.233N     P=0.488N     P=0.235N     | 
|POLY 1.5           |     P=0.313N     P=0.233      (e)          (e)         |P=0.217N     P=0.237N     P=0.491N     P=0.233N     | 
|POLY 6             |     P=0.293N     P=0.246      (e)          (e)         |P=0.226N     P=0.227N     P=0.482N     P=0.235N     | 
|LOGISTIC REGRESSION|     P=0.302N     P=0.273      (e)          (e)         |P=0.214N     (e)          P=0.469N     (e)          | 
|COCH-ARM / FISHERS |     P=0.322N     P=0.237      (e)          (e)         |P=0.213N     P=0.247N     P=0.484N     P=0.237N     | 
|ORDER RESTRICTED   |     P=0.242N     (e)          (e)          (e)         |P=0.073N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 35      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Galactocele                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     6/43 (14%)   1/41 (2%)    6/46 (13%)   2/41 (5%)   |7/48 (15%)   2/46 (4%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     6/37.86      1/36.69      6/41.16      2/37.52     |7/43.91      2/43.12      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     15.9%        2.7%         14.6%        5.3%        |15.9%        4.6%         0.0%         0.0%         | 
|TERMINAL (d)       |     5/23 (22%)   1/28 (4%)    5/32 (16%)   2/29 (7%)   |6/33 (18%)   1/34 (3%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     718          733 (T)      698          733 (T)     |662          605          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.193N     P=0.031N*    P=0.393N     P=0.074N    |P=0.002N**   P=0.076N     P=0.008N**   P=0.009N**   | 
|POLY 3             |     P=0.265N     P=0.058N     P=0.562N     P=0.133N    |P=0.002N**   P=0.082N     P=0.007N**   P=0.008N**   | 
|POLY 1.5           |     P=0.273N     P=0.061N     P=0.572N     P=0.140N    |P=0.002N**   P=0.088N     P=0.008N**   P=0.008N**   | 
|POLY 6             |     P=0.253N     P=0.054N     P=0.536N     P=0.120N    |P=0.002N**   P=0.075N     P=0.007N**   P=0.008N**   | 
|LOGISTIC REGRESSION|     P=0.223N     P=0.037N*    P=0.470N     P=0.088N    |P=0.002N**   P=0.091N     P=0.008N**   P=0.010N*    | 
|COCH-ARM / FISHERS |     P=0.284N     P=0.062N     P=0.572N     P=0.148N    |P=0.002N**   P=0.090N     P=0.006N**   P=0.006N**   | 
|ORDER RESTRICTED   |     P=0.094N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/43 (12%)   4/41 (10%)   4/46 (9%)    5/41 (12%)  |25/48 (52%)  20/46 (43%)  19/48 (40%)  22/48 (46%)  | 
|POLY-3 RATE (b)    |     5/38.15      4/36.69      4/41.02      5/37.59     |25/44.69     20/42.76     19/44.41     22/43.33     | 
|POLY-3 PERCENT (g) |     13.1%        10.9%        9.8%         13.3%       |56.0%        46.8%        42.8%        50.8%        | 
|TERMINAL (d)       |     3/23 (13%)   4/28 (14%)   4/32 (13%)   4/29 (14%)  |19/33 (58%)  19/34 (56%)  14/35 (40%)  20/34 (59%)  | 
|FIRST INCIDENCE    |     639          733 (T)      733 (T)      717         |589          716          657          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.492N     P=0.395N     P=0.321N     P=0.502N    |P=0.361N     P=0.162N     P=0.119N     P=0.305N     | 
|POLY 3             |     P=0.529      P=0.525N     P=0.454N     P=0.623     |P=0.402N     P=0.257N     P=0.148N     P=0.391N     | 
|POLY 1.5           |     P=0.519      P=0.529N     P=0.460N     P=0.611     |P=0.383N     P=0.274N     P=0.161N     P=0.375N     | 
|POLY 6             |     P=0.547      P=0.513N     P=0.437N     P=0.622N    |P=0.412N     P=0.234N     P=0.123N     P=0.399N     | 
|LOGISTIC REGRESSION|     P=0.554N     P=0.488N     P=0.412N     P=0.602N    |P=0.429N     P=0.164N     P=0.129N     P=0.381N     | 
|COCH-ARM / FISHERS |     P=0.511      P=0.531N     P=0.457N     P=0.600     |P=0.355N     P=0.265N     P=0.153N     P=0.342N     | 
|ORDER RESTRICTED   |     P=0.608      (e)          (e)          (e)         |P=0.300N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 36      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland: Duct                                                                                                              | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     12/43 (28%)  6/41 (15%)   3/46 (7%)    4/41 (10%)  |10/48 (21%)  13/46 (28%)  7/48 (15%)   3/48 (6%)    | 
|POLY-3 RATE (b)    |     12/39.90     6/38.45      3/41.61      4/38.07     |10/43.91     13/43.99     7/43.89      3/42.99      | 
|POLY-3 PERCENT (g) |     30.1%        15.6%        7.2%         10.5%       |22.8%        29.6%        16.0%        7.0%         | 
|TERMINAL (d)       |     5/23 (22%)   0/28 (0%)    1/32 (3%)    2/29 (7%)   |9/33 (27%)   7/34 (21%)   6/35 (17%)   2/34 (6%)    | 
|FIRST INCIDENCE    |     577          567          599          658         |662          561          676          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.015N*    P=0.080N     P=0.006N**   P=0.018N*   |P=0.009N**   P=0.371      P=0.249N     P=0.034N*    | 
|POLY 3             |     P=0.018N*    P=0.103N     P=0.007N**   P=0.029N*   |P=0.007N**   P=0.316      P=0.295N     P=0.036N*    | 
|POLY 1.5           |     P=0.018N*    P=0.108N     P=0.007N**   P=0.030N*   |P=0.007N**   P=0.289      P=0.305N     P=0.036N*    | 
|POLY 6             |     P=0.017N*    P=0.095N     P=0.006N**   P=0.027N*   |P=0.008N**   P=0.359      P=0.277N     P=0.035N*    | 
|LOGISTIC REGRESSION|     P=0.020N*    P=0.106N     P=0.007N**   P=0.038N*   |P=0.008N**   P=0.277      P=0.267N     P=0.040N*    | 
|COCH-ARM / FISHERS |     P=0.019N*    P=0.112N     P=0.007N**   P=0.032N*   |P=0.007N**   P=0.275      P=0.297N     P=0.035N*    | 
|ORDER RESTRICTED   |     P=0.006N**   (e)          (e)          (e)         |P=0.013N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Accessory Spleen                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/5 (0%)     0/3 (0%)     2/6 (33%)    0/3 (0%)    |0/8 (0%)     2/7 (29%)    0/1 (0%)     1/4 (25%)    | 
|POLY-3 RATE (b)    |     0/4.32       0/3.00       2/4.79       0/2.94      |0/5.94       2/7.00       0/1.00       1/3.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         41.7%        0.0%        |0.0%         28.6%        0.0%         26.5%        | 
|TERMINAL (d)       |     0/2 (0%)     0/3 (0%)     2/2 (100%)   0/2 (0%)    |0/2 (0%)     2/7 (29%)    0/1 (0%)     1/3 (33%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      ---         |---          734 (T)      ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.522      (e)          P=0.193      (e)         |P=0.495      P=0.540      (e)          P=0.581      | 
|POLY 3             |     P=0.579      (e)          P=0.227      (e)         |P=0.441      P=0.260      (e)          P=0.402      | 
|POLY 1.5           |     P=0.549      (e)          P=0.237      (e)         |P=0.401      P=0.224      (e)          P=0.379      | 
|POLY 6             |     P=0.621      (e)          P=0.224      (e)         |P=0.497      P=0.321      (e)          P=0.439      | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.193      (e)         |(e)          P=0.540      (e)          P=0.581      | 
|COCH-ARM / FISHERS |     P=0.511      (e)          P=0.273      (e)         |P=0.348      P=0.200      (e)          P=0.333      | 
|ORDER RESTRICTED   |     P=0.249      (e)          (e)          (e)         |P=0.229      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 37      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery                                                                                                                        | 
|     Polyarteritis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/5 (0%)     0/3 (0%)     2/6 (33%)    1/3 (33%)   |0/8 (0%)     0/7 (0%)     0/1 (0%)     0/4 (0%)     | 
|POLY-3 RATE (b)    |     0/4.32       0/3.00       2/5.06       1/2.94      |0/5.94       0/7.00       0/1.00       0/3.78       | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         39.6%        34.1%       |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/2 (0%)     0/3 (0%)     1/2 (50%)    1/2 (50%)   |0/2 (0%)     0/7 (0%)     0/1 (0%)     0/3 (0%)     | 
|FIRST INCIDENCE    |     ---          ---          662          733 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.188      (e)          P=0.257      P=0.500     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.160      (e)          P=0.244      P=0.417     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.152      (e)          P=0.245      P=0.405     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.176      (e)          P=0.258      P=0.440     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.144      (e)          P=0.243      P=0.500     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.137      (e)          P=0.273      P=0.375     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.186      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/5 (60%)    3/3 (100%)   2/6 (33%)    2/3 (67%)   |6/8 (75%)    5/7 (71%)    1/1 (100%)   3/4 (75%)    | 
|POLY-3 RATE (b)    |     3/4.83       3/3.00       2/5.70       2/3.00      |6/6.91       5/7.00       1/1.00       3/4.00       | 
|POLY-3 PERCENT (g) |     62.1%        100.0%       35.1%        66.7%       |86.8%        71.4%        100.0%       75.0%        | 
|TERMINAL (d)       |     1/2 (50%)    3/3 (100%)   0/2 (0%)     1/2 (50%)   |2/2 (100%)   5/7 (71%)    1/1 (100%)   2/3 (67%)    | 
|FIRST INCIDENCE    |     662          733 (T)      435          717         |627          734 (T)      734 (T)      676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.376N     P=0.530N     P=0.438N     P=0.473N    |P=0.151N     P=0.038N*    P=0.061N     P=0.132N     | 
|POLY 3             |     P=0.454N     P=0.363      P=0.404N     P=0.713     |P=0.566N     P=0.482N     P=0.955      P=0.638N     | 
|POLY 1.5           |     P=0.457N     P=0.352      P=0.401N     P=0.701     |P=0.608N     P=0.566N     P=0.856      P=0.694N     | 
|POLY 6             |     P=0.448N     P=0.384      P=0.408N     P=0.733     |P=0.512N     P=0.364N     P=1.000      P=0.536N     | 
|LOGISTIC REGRESSION|     P=0.488N     P=0.289      P=0.342N     P=0.578     |P=0.475N     P=0.187N     P=0.061N     P=0.423N     | 
|COCH-ARM / FISHERS |     P=0.459N     P=0.357      P=0.392N     P=0.714     |P=0.590      P=0.662N     P=0.778      P=0.745N     | 
|ORDER RESTRICTED   |     P=0.339N     (e)          (e)          (e)         |P=0.505N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 38      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Nasolacrimal Duct                                                                                                          | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     10/48 (21%)  15/47 (32%)  16/48 (33%)  12/47 (26%) |21/48 (44%)  19/48 (40%)  18/48 (38%)  19/48 (40%)  | 
|POLY-3 RATE (b)    |     10/42.49     15/43.55     16/43.74     12/43.85    |21/44.96     19/44.96     18/45.23     19/42.91     | 
|POLY-3 PERCENT (g) |     23.5%        34.4%        36.6%        27.4%       |46.7%        42.3%        39.8%        44.3%        | 
|TERMINAL (d)       |     5/24 (21%)   10/30 (33%)  14/34 (41%)  5/30 (17%)  |15/33 (46%)  16/36 (44%)  15/35 (43%)  17/34 (50%)  | 
|FIRST INCIDENCE    |     577          620          599          505         |627          683          470          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.445N     P=0.331      P=0.382      P=0.556     |P=0.412N     P=0.300N     P=0.280N     P=0.391N     | 
|POLY 3             |     P=0.516      P=0.188      P=0.136      P=0.436     |P=0.469N     P=0.416N     P=0.326N     P=0.494N     | 
|POLY 1.5           |     P=0.488      P=0.174      P=0.127      P=0.411     |P=0.439N     P=0.430N     P=0.342N     P=0.465N     | 
|POLY 6             |     P=0.533N     P=0.218      P=0.160      P=0.476     |P=0.502N     P=0.397N     P=0.307N     P=0.526N     | 
|LOGISTIC REGRESSION|     P=0.480      P=0.173      P=0.153      P=0.385     |P=0.457N     P=0.349N     P=0.349N     P=0.457N     | 
|COCH-ARM / FISHERS |     P=0.455      P=0.160      P=0.125      P=0.382     |P=0.398N     P=0.418N     P=0.339N     P=0.418N     | 
|ORDER RESTRICTED   |     P=0.277      (e)          (e)          (e)         |P=0.515N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |6/48 (13%)   5/48 (10%)   10/48 (21%)  7/48 (15%)   | 
|POLY-3 RATE (b)    |                                                        |6/44.92      5/45.68      10/43.89     7/42.99      | 
|POLY-3 PERCENT (g) |                                                        |13.4%        11.0%        22.8%        16.3%        | 
|TERMINAL (d)       |                                                        |2/33 (6%)    4/36 (11%)   9/35 (26%)   6/34 (18%)   | 
|FIRST INCIDENCE    |                                                        |552          60           676          632          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.307      P=0.461N     P=0.245      P=0.506      | 
|POLY 3             |                                                        |P=0.263      P=0.488N     P=0.189      P=0.466      | 
|POLY 1.5           |                                                        |P=0.280      P=0.493N     P=0.190      P=0.478      | 
|POLY 6             |                                                        |P=0.248      P=0.481N     P=0.193      P=0.456      | 
|LOGISTIC REGRESSION|                                                        |P=0.322      P=0.466N     P=0.203      P=0.512      | 
|COCH-ARM / FISHERS |                                                        |P=0.311      P=0.500N     P=0.206      P=0.500      | 
|ORDER RESTRICTED   |                                                        |P=0.272      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 39      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |8/48 (17%)   5/48 (10%)   10/48 (21%)  4/48 (8%)    | 
|POLY-3 RATE (b)    |                                                        |8/44.76      5/44.89      10/44.79     4/43.52      | 
|POLY-3 PERCENT (g) |                                                        |17.9%        11.1%        22.3%        9.2%         | 
|TERMINAL (d)       |                                                        |5/33 (15%)   3/36 (8%)    7/35 (20%)   2/34 (6%)    | 
|FIRST INCIDENCE    |                                                        |552          690          470          405          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.278N     P=0.235N     P=0.440      P=0.180N     | 
|POLY 3             |                                                        |P=0.285N     P=0.273N     P=0.397      P=0.189N     | 
|POLY 1.5           |                                                        |P=0.274N     P=0.281N     P=0.388      P=0.185N     | 
|POLY 6             |                                                        |P=0.298N     P=0.260N     P=0.415      P=0.193N     | 
|LOGISTIC REGRESSION|                                                        |P=0.255N     P=0.274N     P=0.409      P=0.135N     | 
|COCH-ARM / FISHERS |                                                        |P=0.263N     P=0.276N     P=0.397      P=0.178N     | 
|ORDER RESTRICTED   |                                                        |P=0.200N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |3/48 (6%)    3/48 (6%)    3/48 (6%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |                                                        |3/43.64      3/44.69      3/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |                                                        |6.9%         6.7%         6.9%         0.0%         | 
|TERMINAL (d)       |                                                        |3/33 (9%)    2/36 (6%)    3/35 (9%)    0/34 (0%)    | 
|FIRST INCIDENCE    |                                                        |734 (T)      732          734 (T)      ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.088N     P=0.619N     P=0.637N     P=0.115N     | 
|POLY 3             |                                                        |P=0.097N     P=0.651N     P=0.662N     P=0.123N     | 
|POLY 1.5           |                                                        |P=0.094N     P=0.660N     P=0.658      P=0.122N     | 
|POLY 6             |                                                        |P=0.098N     P=0.638N     P=0.652N     P=0.122N     | 
|LOGISTIC REGRESSION|                                                        |P=0.088N     P=0.614N     P=0.637N     (e)          | 
|COCH-ARM / FISHERS |                                                        |P=0.090N     P=0.661N     P=0.661N     P=0.121N     | 
|ORDER RESTRICTED   |                                                        |P=0.115N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 40      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    2/47 (4%)    2/48 (4%)    1/47 (2%)   |0/48 (0%)    2/48 (4%)    3/47 (6%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     1/41.39      2/42.07      2/43.02      1/42.42     |0/43.64      2/44.68      3/42.81      1/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         4.8%         4.7%         2.4%        |0.0%         4.5%         7.0%         2.4%         | 
|TERMINAL (d)       |     1/24 (4%)    2/30 (7%)    2/34 (6%)    1/30 (3%)   |0/33 (0%)    2/36 (6%)    2/35 (6%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      733 (T)      733 (T)     |---          734 (T)      724          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.473N     P=0.578      P=0.621      P=0.712N    |P=0.463      P=0.258      P=0.135      P=0.506      | 
|POLY 3             |     P=0.524N     P=0.506      P=0.514      P=0.755N    |P=0.444      P=0.242      P=0.115      P=0.495      | 
|POLY 1.5           |     P=0.532N     P=0.499      P=0.505      P=0.760N    |P=0.451      P=0.238      P=0.113      P=0.497      | 
|POLY 6             |     P=0.512N     P=0.517      P=0.530      P=0.748N    |P=0.440      P=0.249      P=0.119      P=0.495      | 
|LOGISTIC REGRESSION|     P=0.473N     P=0.578      P=0.621      P=0.712N    |P=0.451      P=0.258      P=0.127      P=0.506      | 
|COCH-ARM / FISHERS |     P=0.541N     P=0.492      P=0.500      P=0.747     |P=0.462      P=0.247      P=0.117      P=0.500      | 
|ORDER RESTRICTED   |     P=0.546N     (e)          (e)          (e)         |P=0.183      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     28/48 (58%)  16/47 (34%)  24/48 (50%)  22/47 (47%) |20/48 (42%)  16/48 (33%)  17/47 (36%)  18/48 (38%)  | 
|POLY-3 RATE (b)    |     28/45.72     16/43.24     24/44.15     22/45.08    |20/44.48     16/45.10     17/43.29     18/44.49     | 
|POLY-3 PERCENT (g) |     61.3%        37.0%        54.4%        48.8%       |45.0%        35.5%        39.3%        40.5%        | 
|TERMINAL (d)       |     12/24 (50%)  11/30 (37%)  20/34 (59%)  14/30 (47%) |17/33 (52%)  14/36 (39%)  14/35 (40%)  13/34 (38%)  | 
|FIRST INCIDENCE    |     541          606          543          475         |589          625          657          484          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.221N     P=0.007N**   P=0.049N*    P=0.073N    |P=0.486N     P=0.170N     P=0.263N     P=0.393N     | 
|POLY 3             |     P=0.389N     P=0.016N*    P=0.325N     P=0.159N    |P=0.490N     P=0.240N     P=0.372N     P=0.414N     | 
|POLY 1.5           |     P=0.407N     P=0.015N*    P=0.307N     P=0.167N    |P=0.485N     P=0.262N     P=0.387N     P=0.420N     | 
|POLY 6             |     P=0.372N     P=0.017N*    P=0.335N     P=0.154N    |P=0.487N     P=0.211N     P=0.339N     P=0.397N     | 
|LOGISTIC REGRESSION|     P=0.422N     P=0.015N*    P=0.252N     P=0.214N    |P=0.529N     P=0.204N     P=0.335N     P=0.446N     | 
|COCH-ARM / FISHERS |     P=0.435N     P=0.015N*    P=0.270N     P=0.179N    |P=0.478N     P=0.264N     P=0.368N     P=0.417N     | 
|ORDER RESTRICTED   |     P=0.118N     (e)          (e)          (e)         |P=0.414N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 41      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Artery                                                                                                                 | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    2/48 (4%)    4/47 (9%)   |0/48 (0%)    0/48 (0%)    0/47 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.07      2/43.02      4/43.14     |0/43.64      0/44.68      0/42.77      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         4.7%         9.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    2/34 (6%)    3/30 (10%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      733 (T)      475         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.028 *    P=0.545      P=0.318      P=0.086     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.024 *    P=0.503      P=0.246      P=0.065     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.022 *    P=0.500      P=0.241      P=0.062     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.026 *    P=0.510      P=0.257      P=0.070     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.020 *    P=0.545      P=0.318      P=0.051     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.021 *    P=0.495      P=0.247      P=0.056     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.021 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/38 (5%)    2/41 (5%)    0/40 (0%)    1/42 (2%)   |0/42 (0%)    0/37 (0%)    0/40 (0%)    0/36 (0%)    | 
|POLY-3 RATE (b)    |     2/32.19      2/37.17      0/35.28      1/38.21     |0/38.18      0/35.00      0/36.55      0/31.77      | 
|POLY-3 PERCENT (g) |     6.2%         5.4%         0.0%         2.6%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/15 (7%)    1/27 (4%)    0/27 (0%)    1/28 (4%)   |0/30 (0%)    0/29 (0%)    0/29 (0%)    0/25 (0%)    | 
|FIRST INCIDENCE    |     613          671          ---          733 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.204N     P=0.578N     P=0.177N     P=0.356N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.250N     P=0.642N     P=0.216N     P=0.440N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.253N     P=0.654N     P=0.222N     P=0.452N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.245N     P=0.620N     P=0.204N     P=0.421N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.256N     P=0.683N     P=0.227N     P=0.471N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.255N     P=0.663N     P=0.234N     P=0.462N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.218N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 42      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland                                                                                                                  | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/45 (0%)    2/46 (4%)    1/48 (2%)    0/45 (0%)   |3/47 (6%)    1/47 (2%)    1/45 (2%)    2/46 (4%)    | 
|POLY-3 RATE (b)    |     0/38.91      2/41.16      1/43.02      0/40.96     |3/43.48      1/43.68      1/41.91      2/40.63      | 
|POLY-3 PERCENT (g) |     0.0%         4.9%         2.3%         0.0%        |6.9%         2.3%         2.4%         4.9%         | 
|TERMINAL (d)       |     0/23 (0%)    2/30 (7%)    1/34 (3%)    0/30 (0%)   |2/33 (6%)    1/35 (3%)    1/35 (3%)    2/32 (6%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      733 (T)      ---         |589          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.348N     P=0.298      P=0.578      (e)         |P=0.519N     P=0.289N     P=0.291N     P=0.515N     | 
|POLY 3             |     P=0.381N     P=0.249      P=0.520      (e)         |P=0.521N     P=0.303N     P=0.318N     P=0.531N     | 
|POLY 1.5           |     P=0.390N     P=0.246      P=0.516      (e)         |P=0.516N     P=0.308N     P=0.321N     P=0.523N     | 
|POLY 6             |     P=0.366N     P=0.257      P=0.529      (e)         |P=0.526N     P=0.297N     P=0.313N     P=0.538N     | 
|LOGISTIC REGRESSION|     (e)          P=0.298      P=0.578      (e)         |P=0.518N     P=0.300N     P=0.321N     P=0.512N     | 
|COCH-ARM / FISHERS |     P=0.399N     P=0.253      P=0.516      (e)         |P=0.511N     P=0.308N     P=0.325N     P=0.510N     | 
|ORDER RESTRICTED   |     P=0.326N     (e)          (e)          (e)         |P=0.313N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/45 (4%)    3/46 (7%)    5/48 (10%)   3/45 (7%)   |8/47 (17%)   4/47 (9%)    6/45 (13%)   1/46 (2%)    | 
|POLY-3 RATE (b)    |     2/39.16      3/41.16      5/43.02      3/40.96     |8/43.35      4/44.07      6/42.57      1/40.63      | 
|POLY-3 PERCENT (g) |     5.1%         7.3%         11.6%        7.3%        |18.5%        9.1%         14.1%        2.5%         | 
|TERMINAL (d)       |     1/23 (4%)    3/30 (10%)   5/34 (15%)   3/30 (10%)  |6/33 (18%)   3/35 (9%)    4/35 (11%)   1/32 (3%)    | 
|FIRST INCIDENCE    |     666          733 (T)      733 (T)      733 (T)     |653          625          626          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.503      P=0.606      P=0.380      P=0.606     |P=0.035N*    P=0.156N     P=0.351N     P=0.021N*    | 
|POLY 3             |     P=0.426      P=0.523      P=0.255      P=0.521     |P=0.037N*    P=0.168N     P=0.400N     P=0.020N*    | 
|POLY 1.5           |     P=0.413      P=0.516      P=0.247      P=0.511     |P=0.034N*    P=0.176N     P=0.411N     P=0.019N*    | 
|POLY 6             |     P=0.446      P=0.535      P=0.272      P=0.537     |P=0.041N*    P=0.156N     P=0.380N     P=0.020N*    | 
|LOGISTIC REGRESSION|     P=0.462      P=0.546      P=0.293      P=0.548     |P=0.033N*    P=0.174N     P=0.417N     P=0.022N*    | 
|COCH-ARM / FISHERS |     P=0.399      P=0.511      P=0.245      P=0.500     |P=0.032N*    P=0.177N     P=0.421N     P=0.016N*    | 
|ORDER RESTRICTED   |     P=0.374      (e)          (e)          (e)         |P=0.013N*    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 43      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/45 (2%)    7/46 (15%)   2/48 (4%)    7/45 (16%)  |2/47 (4%)    4/47 (9%)    4/45 (9%)    5/46 (11%)   | 
|POLY-3 RATE (b)    |     1/38.91      7/41.67      2/43.02      7/41.83     |2/43.00      4/43.68      4/41.91      5/40.69      | 
|POLY-3 PERCENT (g) |     2.6%         16.8%        4.7%         16.7%       |4.7%         9.2%         9.5%         12.3%        | 
|TERMINAL (d)       |     1/23 (4%)    5/30 (17%)   2/34 (6%)    3/30 (10%)  |2/33 (6%)    4/35 (11%)   4/35 (11%)   4/32 (13%)   | 
|FIRST INCIDENCE    |     733 (T)      579          733 (T)      645         |734 (T)      734 (T)      734 (T)      719          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.169      P=0.065      P=0.636      P=0.064     |P=0.181      P=0.363      P=0.363      P=0.208      | 
|POLY 3             |     P=0.126      P=0.036 *    P=0.535      P=0.037 *   |P=0.177      P=0.344      P=0.325      P=0.193      | 
|POLY 1.5           |     P=0.115      P=0.034 *    P=0.527      P=0.033 *   |P=0.184      P=0.337      P=0.320      P=0.198      | 
|POLY 6             |     P=0.146      P=0.041 *    P=0.551      P=0.045 *   |P=0.172      P=0.355      P=0.334      P=0.190      | 
|LOGISTIC REGRESSION|     P=0.117      P=0.039 *    P=0.636      P=0.033 *   |P=0.169      P=0.363      P=0.363      P=0.192      | 
|COCH-ARM / FISHERS |     P=0.108      P=0.031 *    P=0.524      P=0.029 *   |P=0.193      P=0.339      P=0.318      P=0.209      | 
|ORDER RESTRICTED   |     P=0.024 *    (e)          (e)          (e)         |P=0.173      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/48 (0%)    3/47 (6%)   |                                                    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      0/43.02      3/42.55     |                                                    | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         7.1%        |                                                    | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |                                                    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          698         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.089      P=0.455N     P=0.431N     P=0.376     |                                                    | 
|POLY 3             |     P=0.074      P=0.497N     P=0.492N     P=0.315     |                                                    | 
|POLY 1.5           |     P=0.073      P=0.500N     P=0.497N     P=0.307     |                                                    | 
|POLY 6             |     P=0.075      P=0.490N     P=0.483N     P=0.329     |                                                    | 
|LOGISTIC REGRESSION|     P=0.082      (e)          (e)          P=0.339     |                                                    | 
|COCH-ARM / FISHERS |     P=0.074      P=0.505N     P=0.500N     P=0.301     |                                                    | 
|ORDER RESTRICTED   |     P=0.041 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 44      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    1/47 (2%)    0/48 (0%)    3/47 (6%)   |                                                    | 
|POLY-3 RATE (b)    |     1/41.73      1/42.07      0/43.02      3/42.66     |                                                    | 
|POLY-3 PERCENT (g) |     2.4%         2.4%         0.0%         7.0%        |                                                    | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    1/30 (3%)   |                                                    | 
|FIRST INCIDENCE    |     639          733 (T)      ---          698         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.190      P=0.739N     P=0.485N     P=0.362     |                                                    | 
|POLY 3             |     P=0.163      P=0.759N     P=0.494N     P=0.313     |                                                    | 
|POLY 1.5           |     P=0.161      P=0.759      P=0.498N     P=0.306     |                                                    | 
|POLY 6             |     P=0.167      P=0.753N     P=0.486N     P=0.325     |                                                    | 
|LOGISTIC REGRESSION|     P=0.159      P=0.753      P=0.479N     P=0.291     |                                                    | 
|COCH-ARM / FISHERS |     P=0.159      P=0.747      P=0.500N     P=0.301     |                                                    | 
|ORDER RESTRICTED   |     P=0.105      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     35/48 (73%)  36/47 (77%)  38/48 (79%)  29/47 (62%) |                                                    | 
|POLY-3 RATE (b)    |     35/45.84     36/44.91     38/47.00     29/45.38    |                                                    | 
|POLY-3 PERCENT (g) |     76.4%        80.2%        80.9%        63.9%       |                                                    | 
|TERMINAL (d)       |     17/24 (71%)  24/30 (80%)  28/34 (82%)  19/30 (63%) |                                                    | 
|FIRST INCIDENCE    |     541          567          435          475         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.034N*    P=0.269N     P=0.192N     P=0.053N    |                                                    | 
|POLY 3             |     P=0.062N     P=0.424      P=0.389      P=0.136N    |                                                    | 
|POLY 1.5           |     P=0.077N     P=0.423      P=0.355      P=0.151N    |                                                    | 
|POLY 6             |     P=0.048N*    P=0.435      P=0.441      P=0.117N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.092N     P=0.477      P=0.321      P=0.165N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.100N     P=0.430      P=0.317      P=0.172N    |                                                    | 
|ORDER RESTRICTED   |     P=0.059N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 45      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland: Duct                                                                                                            | 
|     Ectasia                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     7/48 (15%)   8/47 (17%)   11/48 (23%)  9/47 (19%)  |                                                    | 
|POLY-3 RATE (b)    |     7/41.83      8/42.07      11/43.02     9/42.52     |                                                    | 
|POLY-3 PERCENT (g) |     16.7%        19.0%        25.6%        21.2%       |                                                    | 
|TERMINAL (d)       |     5/24 (21%)   8/30 (27%)   11/34 (32%)  8/30 (27%)  |                                                    | 
|FIRST INCIDENCE    |     639          733 (T)      733 (T)      707         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.462      P=0.557N     P=0.488      P=0.571     |                                                    | 
|POLY 3             |     P=0.328      P=0.505      P=0.232      P=0.405     |                                                    | 
|POLY 1.5           |     P=0.315      P=0.493      P=0.221      P=0.390     |                                                    | 
|POLY 6             |     P=0.349      P=0.526      P=0.259      P=0.428     |                                                    | 
|LOGISTIC REGRESSION|     P=0.381      P=0.583      P=0.333      P=0.473     |                                                    | 
|COCH-ARM / FISHERS |     P=0.301      P=0.482      P=0.217      P=0.375     |                                                    | 
|ORDER RESTRICTED   |     P=0.358      (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate                                                                                                                         | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     29/48 (60%)  21/47 (45%)  22/48 (46%)  18/47 (38%) |                                                    | 
|POLY-3 RATE (b)    |     29/44.69     21/44.91     22/46.06     18/44.15    |                                                    | 
|POLY-3 PERCENT (g) |     64.9%        46.8%        47.8%        40.8%       |                                                    | 
|TERMINAL (d)       |     16/24 (67%)  13/30 (43%)  15/34 (44%)  13/30 (43%) |                                                    | 
|FIRST INCIDENCE    |     564          487          435          505         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.016N*    P=0.031N*    P=0.017N*    P=0.007N**  |                                                    | 
|POLY 3             |     P=0.033N*    P=0.059N     P=0.071N     P=0.016N*   |                                                    | 
|POLY 1.5           |     P=0.036N*    P=0.072N     P=0.088N     P=0.019N*   |                                                    | 
|POLY 6             |     P=0.030N*    P=0.045N*    P=0.050N     P=0.012N*   |                                                    | 
|LOGISTIC REGRESSION|     P=0.043N*    P=0.093N     P=0.112N     P=0.022N*   |                                                    | 
|COCH-ARM / FISHERS |     P=0.040N*    P=0.092N     P=0.110N     P=0.025N*   |                                                    | 
|ORDER RESTRICTED   |     P=0.013N*    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 46      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Prostate: Ventral                                                                                                                | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    3/47 (6%)    1/48 (2%)    6/47 (13%)  |                                                    | 
|POLY-3 RATE (b)    |     1/41.39      3/42.07      1/43.02      6/42.93     |                                                    | 
|POLY-3 PERCENT (g) |     2.4%         7.1%         2.3%         14.0%       |                                                    | 
|TERMINAL (d)       |     1/24 (4%)    3/30 (10%)   1/34 (3%)    4/30 (13%)  |                                                    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      733 (T)      601         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.054      P=0.387      P=0.682N     P=0.094     |                                                    | 
|POLY 3             |     P=0.040 *    P=0.311      P=0.752N     P=0.061     |                                                    | 
|POLY 1.5           |     P=0.038 *    P=0.304      P=0.757N     P=0.057     |                                                    | 
|POLY 6             |     P=0.044 *    P=0.323      P=0.741N     P=0.068     |                                                    | 
|LOGISTIC REGRESSION|     P=0.043 *    P=0.387      P=0.682N     P=0.062     |                                                    | 
|COCH-ARM / FISHERS |     P=0.037 *    P=0.301      P=0.753N     P=0.052     |                                                    | 
|ORDER RESTRICTED   |     P=0.020 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    1/48 (2%)    0/47 (0%)   |2/48 (4%)    0/48 (0%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      1/43.02      0/42.42     |2/44.02      0/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         0.0%        |4.5%         0.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          733 (T)      ---         |627          ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.695      (e)          P=0.569      (e)         |P=0.501N     P=0.230N     P=0.236N     P=0.496N     | 
|POLY 3             |     P=0.679      (e)          P=0.508      (e)         |P=0.503N     P=0.234N     P=0.239N     P=0.511N     | 
|POLY 1.5           |     P=0.674      (e)          P=0.503      (e)         |P=0.500N     P=0.237N     P=0.240N     P=0.508N     | 
|POLY 6             |     P=0.687      (e)          P=0.517      (e)         |P=0.506N     P=0.229N     P=0.235N     P=0.513N     | 
|LOGISTIC REGRESSION|     (e)          (e)          P=0.569      (e)         |P=0.497N     P=0.227N     P=0.224N     P=0.495N     | 
|COCH-ARM / FISHERS |     P=0.667      (e)          P=0.500      (e)         |P=0.499N     P=0.247N     P=0.247N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.388      (e)          (e)          (e)         |P=0.137N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 47      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Seminal Vesicle                                                                                                                  | 
|     Decreased Secretory Fluid                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     28/48 (58%)  31/47 (66%)  33/48 (69%)  36/47 (77%) |                                                    | 
|POLY-3 RATE (b)    |     28/45.42     31/43.98     33/44.69     36/44.74    |                                                    | 
|POLY-3 PERCENT (g) |     61.6%        70.5%        73.8%        80.5%       |                                                    | 
|TERMINAL (d)       |     14/24 (58%)  22/30 (73%)  26/34 (77%)  24/30 (80%) |                                                    | 
|FIRST INCIDENCE    |     541          606          599          601         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.304      P=0.438N     P=0.359N     P=0.393     |                                                    | 
|POLY 3             |     P=0.030 *    P=0.249      P=0.148      P=0.034 *   |                                                    | 
|POLY 1.5           |     P=0.031 *    P=0.261      P=0.158      P=0.036 *   |                                                    | 
|POLY 6             |     P=0.034 *    P=0.252      P=0.162      P=0.037 *   |                                                    | 
|LOGISTIC REGRESSION|     P=0.054      P=0.323      P=0.218      P=0.059     |                                                    | 
|COCH-ARM / FISHERS |     P=0.040 *    P=0.290      P=0.198      P=0.046 *   |                                                    | 
|ORDER RESTRICTED   |     P=0.026 *    (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Cyst Epithelial Inclusion                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    2/47 (4%)    0/47 (0%)    1/47 (2%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/41.80      2/42.07      0/42.39      1/42.69     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         4.8%         0.0%         2.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    2/30 (7%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     613          733 (T)      ---          660         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.239N     P=0.635N     P=0.202N     P=0.457N    |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.275N     P=0.692N     P=0.234N     P=0.493N    |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.278N     P=0.691      P=0.239N     P=0.500N    |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.269N     P=0.683N     P=0.224N     P=0.481N    |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.283N     P=0.694      P=0.242N     P=0.530N    |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.281N     P=0.684      P=0.253N     P=0.508N    |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.261N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 48      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    1/47 (2%)    0/47 (0%)   |2/48 (4%)    0/48 (0%)    1/48 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      1/43.17      0/42.42     |2/43.64      0/44.68      1/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.3%         0.0%        |4.6%         0.0%         2.3%         2.4%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |2/33 (6%)    0/36 (0%)    1/35 (3%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          439          ---         |734 (T)      ---          734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.666      (e)          P=0.496      (e)         |P=0.544N     P=0.219N     P=0.479N     P=0.490N     | 
|POLY 3             |     P=0.677      (e)          P=0.508      (e)         |P=0.553N     P=0.232N     P=0.500N     P=0.508N     | 
|POLY 1.5           |     P=0.672      (e)          P=0.502      (e)         |P=0.548N     P=0.236N     P=0.504N     P=0.506N     | 
|POLY 6             |     P=0.684      (e)          P=0.520      (e)         |P=0.559N     P=0.225N     P=0.492N     P=0.508N     | 
|LOGISTIC REGRESSION|     P=0.999N     (e)          (e)          (e)         |P=0.544N     (e)          P=0.479N     P=0.490N     | 
|COCH-ARM / FISHERS |     P=0.666      (e)          P=0.495      (e)         |P=0.543N     P=0.247N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.389      (e)          (e)          (e)         |P=0.276N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/47 (0%)    1/47 (2%)   |3/48 (6%)    1/48 (2%)    3/48 (6%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      0/42.39      1/42.42     |3/43.64      1/44.68      3/43.67      3/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         0.0%         2.4%        |6.9%         2.2%         6.9%         7.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |3/33 (9%)    1/36 (3%)    3/35 (9%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          ---          733 (T)     |734 (T)      734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.599      P=0.455N     P=0.431N     P=0.712N    |P=0.415      P=0.274N     P=0.637N     P=0.650N     | 
|POLY 3             |     P=0.561      P=0.497N     P=0.495N     P=0.755N    |P=0.396      P=0.297N     P=0.662N     P=0.652      | 
|POLY 1.5           |     P=0.560      P=0.500N     P=0.500N     P=0.760N    |P=0.406      P=0.304N     P=0.658      P=0.654      | 
|POLY 6             |     P=0.562      P=0.490N     P=0.485N     P=0.748N    |P=0.388      P=0.286N     P=0.652N     P=0.652      | 
|LOGISTIC REGRESSION|     P=0.599      (e)          (e)          P=0.712N    |P=0.415      P=0.274N     P=0.637N     P=0.650N     | 
|COCH-ARM / FISHERS |     P=0.559      P=0.505N     P=0.505N     P=0.747     |P=0.416      P=0.308N     P=0.661N     P=0.661N     | 
|ORDER RESTRICTED   |     P=0.393N     (e)          (e)          (e)         |P=0.489      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 49      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epidermis                                                                                                                  | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/47 (0%)    1/47 (2%)   |1/48 (2%)    1/48 (2%)    2/48 (4%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/42.39      1/42.42     |1/43.64      1/44.68      2/43.67      3/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         2.4%        |2.3%         2.2%         4.6%         7.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    1/30 (3%)   |1/33 (3%)    1/36 (3%)    2/35 (6%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          733 (T)     |734 (T)      734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.203      (e)          (e)          P=0.545     |P=0.154      P=0.742N     P=0.521      P=0.315      | 
|POLY 3             |     P=0.194      (e)          (e)          P=0.505     |P=0.148      P=0.755N     P=0.500      P=0.297      | 
|POLY 1.5           |     P=0.192      (e)          (e)          P=0.501     |P=0.152      P=0.760N     P=0.496      P=0.299      | 
|POLY 6             |     P=0.197      (e)          (e)          P=0.512     |P=0.145      P=0.749N     P=0.508      P=0.296      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.545     |P=0.154      P=0.742N     P=0.521      P=0.315      | 
|COCH-ARM / FISHERS |     P=0.189      (e)          (e)          P=0.495     |P=0.157      P=0.753N     P=0.500      P=0.308      | 
|ORDER RESTRICTED   |     P=0.125      (e)          (e)          (e)         |P=0.207      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin: Epithelium                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/47 (0%)    2/47 (4%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/42.39      2/42.42     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         4.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          733 (T)     |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.049 *    (e)          (e)          P=0.288     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.044 *    (e)          (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.043 *    (e)          (e)          P=0.238     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.045 *    (e)          (e)          P=0.250     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.288     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.043 *    (e)          (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.031 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 50      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     5/48 (10%)   6/47 (13%)   1/48 (2%)    5/47 (11%)  |0/48 (0%)    0/48 (0%)    0/48 (0%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     5/41.39      6/42.07      1/43.02      5/42.42     |0/43.64      0/44.68      0/43.67      1/42.63      | 
|POLY-3 PERCENT (g) |     12.1%        14.3%        2.3%         11.8%       |0.0%         0.0%         0.0%         2.4%         | 
|TERMINAL (d)       |     5/24 (21%)   6/30 (20%)   1/34 (3%)    5/30 (17%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    1/34 (3%)    | 
|FIRST INCIDENCE    |     733 (T)      733 (T)      733 (T)      733 (T)     |---          ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.301N     P=0.603N     P=0.040N*    P=0.485N    |P=0.189      (e)          (e)          P=0.506      | 
|POLY 3             |     P=0.400N     P=0.512      P=0.092N     P=0.616N    |P=0.186      (e)          (e)          P=0.495      | 
|POLY 1.5           |     P=0.410N     P=0.498      P=0.097N     P=0.629N    |P=0.189      (e)          (e)          P=0.497      | 
|POLY 6             |     P=0.384N     P=0.535      P=0.081N     P=0.594N    |P=0.185      (e)          (e)          P=0.495      | 
|LOGISTIC REGRESSION|     P=0.301N     P=0.603N     P=0.040N*    P=0.485N    |(e)          (e)          (e)          P=0.506      | 
|COCH-ARM / FISHERS |     P=0.419N     P=0.485      P=0.102N     P=0.616     |P=0.191      (e)          (e)          P=0.500      | 
|ORDER RESTRICTED   |     P=0.277N     (e)          (e)          (e)         |P=0.116      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    3/47 (6%)    1/48 (2%)    8/47 (17%)  |3/48 (6%)    4/48 (8%)    6/48 (13%)   5/48 (10%)   | 
|POLY-3 RATE (b)    |     2/41.39      3/42.10      1/43.75      8/43.50     |3/44.89      4/45.68      6/44.42      5/44.32      | 
|POLY-3 PERCENT (g) |     4.8%         7.1%         2.3%         18.4%       |6.7%         8.8%         13.5%        11.3%        | 
|TERMINAL (d)       |     2/24 (8%)    2/30 (7%)    0/34 (0%)    5/30 (17%)  |0/33 (0%)    1/36 (3%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     733 (T)      724          477          505         |578          605          657          405          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.026 *    P=0.602      P=0.425N     P=0.085     |P=0.265      P=0.527      P=0.279      P=0.352      | 
|POLY 3             |     P=0.017 *    P=0.508      P=0.481N     P=0.052     |P=0.263      P=0.509      P=0.236      P=0.349      | 
|POLY 1.5           |     P=0.016 *    P=0.499      P=0.491N     P=0.047 *   |P=0.270      P=0.500      P=0.234      P=0.352      | 
|POLY 6             |     P=0.019 *    P=0.524      P=0.462N     P=0.061     |P=0.255      P=0.523      P=0.245      P=0.348      | 
|LOGISTIC REGRESSION|     P=0.015 *    P=0.578      P=0.478N     P=0.043 *   |P=0.297      P=0.562      P=0.272      P=0.552      | 
|COCH-ARM / FISHERS |     P=0.016 *    P=0.490      P=0.500N     P=0.042 *   |P=0.276      P=0.500      P=0.243      P=0.357      | 
|ORDER RESTRICTED   |     P=0.013 *    (e)          (e)          (e)         |P=0.296      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 51      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    2/48 (4%)    4/47 (9%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.51      2/43.02      4/43.09     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         4.7%         9.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    2/34 (6%)    3/30 (10%)  |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          604          733 (T)      505         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.028 *    P=0.505      P=0.318      P=0.085     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.023 *    P=0.505      P=0.246      P=0.065     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.022 *    P=0.501      P=0.241      P=0.062     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.025 *    P=0.513      P=0.257      P=0.070     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.019 *    P=0.506      P=0.318      P=0.053     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.021 *    P=0.495      P=0.247      P=0.056     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.021 *    (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    0/48 (0%)    2/47 (4%)   |0/48 (0%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.07      0/43.02      2/42.69     |0/43.64      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         4.7%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    1/30 (3%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      ---          660         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.178      P=0.545      (e)          P=0.279     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.160      P=0.503      (e)          P=0.244     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.156      P=0.500      (e)          P=0.238     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.167      P=0.510      (e)          P=0.253     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.156      P=0.545      (e)          P=0.230     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.152      P=0.495      (e)          P=0.242     |(e)          (e)          (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.078      (e)          (e)          (e)         |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 52      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/48 (6%)    2/47 (4%)    0/48 (0%)    2/47 (4%)   |1/48 (2%)    2/48 (4%)    3/48 (6%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     3/42.35      2/43.18      0/43.02      2/42.84     |1/43.87      2/45.24      3/44.41      1/42.99      | 
|POLY-3 PERCENT (g) |     7.1%         4.6%         0.0%         4.7%        |2.3%         4.4%         6.8%         2.3%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    1/36 (3%)    2/35 (6%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     577          487          ---          676         |673          561          470          633          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.352N     P=0.484N     P=0.112N     P=0.466N    |P=0.576N     P=0.524      P=0.325      P=0.755      | 
|POLY 3             |     P=0.372N     P=0.491N     P=0.115N     P=0.495N    |P=0.581N     P=0.511      P=0.310      P=0.756      | 
|POLY 1.5           |     P=0.373N     P=0.500N     P=0.118N     P=0.502N    |P=0.576N     P=0.503      P=0.305      P=0.757      | 
|POLY 6             |     P=0.369N     P=0.477N     P=0.109N     P=0.482N    |P=0.584N     P=0.521      P=0.318      P=0.757      | 
|LOGISTIC REGRESSION|     P=0.369N     P=0.539N     P=0.098N     P=0.546N    |P=0.556N     P=0.533      P=0.344      P=0.726N     | 
|COCH-ARM / FISHERS |     P=0.372N     P=0.510N     P=0.121N     P=0.510N    |P=0.567N     P=0.500      P=0.308      P=0.753N     | 
|ORDER RESTRICTED   |     P=0.211N     (e)          (e)          (e)         |P=0.464      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Forestomach                                                                                                             | 
|     Edema                                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    1/47 (2%)    2/47 (4%)    0/47 (0%)   |1/48 (2%)    0/48 (0%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     2/42.04      1/42.44      2/42.10      0/42.42     |1/43.70      0/44.68      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         4.8%         0.0%        |2.3%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     564          629          722          ---         |719          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.196N     P=0.485N     P=0.624N     P=0.231N    |P=0.329N     P=0.484N     P=0.489N     P=0.494N     | 
|POLY 3             |     P=0.215N     P=0.497N     P=0.694N     P=0.235N    |P=0.331N     P=0.496N     P=0.500N     P=0.505N     | 
|POLY 1.5           |     P=0.217N     P=0.502N     P=0.689      P=0.238N    |P=0.330N     P=0.499N     P=0.502N     P=0.504N     | 
|POLY 6             |     P=0.212N     P=0.486N     P=0.680N     P=0.229N    |P=0.333N     P=0.490N     P=0.496N     P=0.505N     | 
|LOGISTIC REGRESSION|     P=0.224N     P=0.523N     P=0.687      P=0.248N    |P=0.333N     P=0.496N     P=0.499N     P=0.504N     | 
|COCH-ARM / FISHERS |     P=0.218N     P=0.508N     P=0.684      P=0.253N    |P=0.330N     P=0.500N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.153N     (e)          (e)          (e)         |P=0.125N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 53      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Forestomach                                                                                                             | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/48 (4%)    1/47 (2%)    1/47 (2%)    2/47 (4%)   |2/48 (4%)    0/48 (0%)    1/48 (2%)    1/48 (2%)    | 
|POLY-3 RATE (b)    |     2/41.84      1/42.46      1/42.06      2/42.42     |2/43.91      0/44.68      1/44.67      1/42.85      | 
|POLY-3 PERCENT (g) |     4.8%         2.4%         2.4%         4.7%        |4.6%         0.0%         2.2%         2.3%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    1/34 (3%)    2/30 (7%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     613          620          733 (T)      733 (T)     |662          ---          102          676          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.577      P=0.480N     P=0.434N     P=0.640N    |P=0.553N     P=0.225N     P=0.490N     P=0.505N     | 
|POLY 3             |     P=0.536      P=0.495N     P=0.498N     P=0.689N    |P=0.550N     P=0.233N     P=0.494N     P=0.509N     | 
|POLY 1.5           |     P=0.533      P=0.501N     P=0.504N     P=0.693     |P=0.546N     P=0.237N     P=0.497N     P=0.506N     | 
|POLY 6             |     P=0.540      P=0.484N     P=0.484N     P=0.680N    |P=0.555N     P=0.228N     P=0.488N     P=0.509N     | 
|LOGISTIC REGRESSION|     P=0.526      P=0.526N     P=0.509N     P=0.692     |P=0.545N     P=0.235N     P=0.261N     P=0.487N     | 
|COCH-ARM / FISHERS |     P=0.531      P=0.508N     P=0.508N     P=0.684     |P=0.543N     P=0.247N     P=0.500N     P=0.500N     | 
|ORDER RESTRICTED   |     P=0.540N     (e)          (e)          (e)         |P=0.276N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Forestomach, Epithelium                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    1/47 (2%)    2/47 (4%)   |2/48 (4%)    0/48 (0%)    1/48 (2%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     1/41.39      0/42.07      1/42.06      2/42.42     |2/43.70      0/44.68      1/44.67      0/42.63      | 
|POLY-3 PERCENT (g) |     2.4%         0.0%         2.4%         4.7%        |4.6%         0.0%         2.2%         0.0%         | 
|TERMINAL (d)       |     1/24 (4%)    0/30 (0%)    1/34 (3%)    2/30 (7%)   |1/33 (3%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     733 (T)      ---          733 (T)      733 (T)     |719          ---          102          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.254      P=0.455N     P=0.682N     P=0.578     |P=0.223N     P=0.221N     P=0.487N     P=0.233N     | 
|POLY 3             |     P=0.223      P=0.497N     P=0.757N     P=0.509     |P=0.229N     P=0.232N     P=0.492N     P=0.243N     | 
|POLY 1.5           |     P=0.221      P=0.500N     P=0.759      P=0.501     |P=0.225N     P=0.236N     P=0.497N     P=0.241N     | 
|POLY 6             |     P=0.226      P=0.490N     P=0.747N     P=0.521     |P=0.234N     P=0.226N     P=0.485N     P=0.243N     | 
|LOGISTIC REGRESSION|     P=0.254      (e)          P=0.682N     P=0.578     |P=0.204N     P=0.223N     P=0.287N     P=0.241N     | 
|COCH-ARM / FISHERS |     P=0.217      P=0.505N     P=0.747      P=0.492     |P=0.223N     P=0.247N     P=0.500N     P=0.247N     | 
|ORDER RESTRICTED   |     P=0.233      (e)          (e)          (e)         |P=0.078N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 54      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Interstitial Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     17/48 (35%)  11/47 (23%)  5/48 (10%)   3/47 (6%)   |                                                    | 
|POLY-3 RATE (b)    |     17/44.78     11/42.92     5/44.60      3/43.46     |                                                    | 
|POLY-3 PERCENT (g) |     38.0%        25.6%        11.2%        6.9%        |                                                    | 
|TERMINAL (d)       |     3/24 (13%)   7/30 (23%)   3/34 (9%)    1/30 (3%)   |                                                    | 
|FIRST INCIDENCE    |     541          606          435          475         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P<0.001N**   P=0.091N     P=0.003N**   P<0.001N**  |                                                    | 
|POLY 3             |     P<0.001N**   P=0.154N     P=0.002N**   P<0.001N**  |                                                    | 
|POLY 1.5           |     P<0.001N**   P=0.150N     P=0.003N**   P<0.001N**  |                                                    | 
|POLY 6             |     P<0.001N**   P=0.162N     P=0.002N**   P<0.001N**  |                                                    | 
|LOGISTIC REGRESSION|     P<0.001N**   P=0.157N     P=0.003N**   P<0.001N**  |                                                    | 
|COCH-ARM / FISHERS |     P<0.001N**   P=0.145N     P=0.003N**   P<0.001N**  |                                                    | 
|ORDER RESTRICTED   |     P<0.001N**   (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Seminiferous Tubule                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     11/48 (23%)  7/47 (15%)   3/48 (6%)    8/47 (17%)  |                                                    | 
|POLY-3 RATE (b)    |     11/42.84     7/42.07      3/43.48      8/42.52     |                                                    | 
|POLY-3 PERCENT (g) |     25.7%        16.6%        6.9%         18.8%       |                                                    | 
|TERMINAL (d)       |     6/24 (25%)   6/30 (20%)   2/34 (6%)    6/30 (20%)  |                                                    | 
|FIRST INCIDENCE    |     541          732          599          717         |                                                    | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.183N     P=0.120N     P=0.008N**   P=0.189N    |                                                    | 
|POLY 3             |     P=0.264N     P=0.225N     P=0.017N*    P=0.307N    |                                                    | 
|POLY 1.5           |     P=0.270N     P=0.229N     P=0.018N*    P=0.316N    |                                                    | 
|POLY 6             |     P=0.253N     P=0.214N     P=0.013N*    P=0.292N    |                                                    | 
|LOGISTIC REGRESSION|     P=0.250N     P=0.205N     P=0.022N*    P=0.287N    |                                                    | 
|COCH-ARM / FISHERS |     P=0.277N     P=0.231N     P=0.020N*    P=0.323N    |                                                    | 
|ORDER RESTRICTED   |     P=0.082N     (e)          (e)          (e)         |                                                    | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 55      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/43 (0%)    0/42 (0%)    0/43 (0%)    0/42 (0%)   |0/41 (0%)    2/47 (4%)    1/44 (2%)    1/42 (2%)    | 
|POLY-3 RATE (b)    |     0/37.12      0/38.28      0/38.32      0/38.00     |0/37.19      2/44.24      1/40.47      1/39.15      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         4.5%         2.5%         2.6%         | 
|TERMINAL (d)       |     0/21 (0%)    0/27 (0%)    0/30 (0%)    0/27 (0%)   |0/28 (0%)    2/36 (6%)    1/33 (3%)    1/32 (3%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.556      P=0.295      P=0.533      P=0.527      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.546      P=0.277      P=0.517      P=0.510      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.542      P=0.271      P=0.514      P=0.508      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.553      P=0.285      P=0.522      P=0.514      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.295      P=0.533      P=0.527      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.536      P=0.282      P=0.518      P=0.506      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.301      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     8/47 (17%)   6/47 (13%)   3/48 (6%)    3/46 (7%)   |13/46 (28%)  5/46 (11%)   6/47 (13%)   1/48 (2%)    | 
|POLY-3 RATE (b)    |     8/41.00      6/42.08      3/43.16      3/41.55     |13/42.08     5/43.24      6/42.67      1/42.63      | 
|POLY-3 PERCENT (g) |     19.5%        14.3%        7.0%         7.2%        |30.9%        11.6%        14.1%        2.4%         | 
|TERMINAL (d)       |     6/24 (25%)   5/30 (17%)   2/34 (6%)    3/30 (10%)  |11/33 (33%)  5/35 (14%)   6/34 (18%)   1/34 (3%)    | 
|FIRST INCIDENCE    |     690          729          698          733 (T)     |714          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.029N*    P=0.235N     P=0.035N*    P=0.050N    |P<0.001N**   P=0.023N*    P=0.052N     P<0.001N**   | 
|POLY 3             |     P=0.051N     P=0.365N     P=0.081N     P=0.091N    |P<0.001N**   P=0.025N*    P=0.052N     P<0.001N**   | 
|POLY 1.5           |     P=0.054N     P=0.376N     P=0.088N     P=0.098N    |P<0.001N**   P=0.029N*    P=0.056N     P<0.001N**   | 
|POLY 6             |     P=0.046N*    P=0.345N     P=0.069N     P=0.082N    |P<0.001N**   P=0.020N*    P=0.047N*    P<0.001N**   | 
|LOGISTIC REGRESSION|     P=0.038N*    P=0.279N     P=0.057N     P=0.066N    |P<0.001N**   P=0.017N*    P=0.041N*    P<0.001N**   | 
|COCH-ARM / FISHERS |     P=0.057N     P=0.387N     P=0.093N     P=0.106N    |P<0.001N**   P=0.032N*    P=0.055N     P<0.001N**   | 
|ORDER RESTRICTED   |     P=0.060N     (e)          (e)          (e)         |P<0.001N**   (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 56      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicle                                                                                                          | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/47 (0%)    0/47 (0%)    0/48 (0%)    3/46 (7%)   |0/46 (0%)    1/46 (2%)    0/47 (0%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/40.80      0/42.07      0/43.02      3/41.82     |0/41.94      1/43.27      0/42.67      2/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         7.2%        |0.0%         2.3%         0.0%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    2/30 (7%)   |0/33 (0%)    0/35 (0%)    0/34 (0%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          661         |---          725          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.013 *    (e)          (e)          P=0.157     |P=0.156      P=0.528      (e)          P=0.245      | 
|POLY 3             |     P=0.010 *    (e)          (e)          P=0.122     |P=0.159      P=0.506      (e)          P=0.241      | 
|POLY 1.5           |     P=0.010 *    (e)          (e)          P=0.119     |P=0.160      P=0.502      (e)          P=0.242      | 
|POLY 6             |     P=0.010 *    (e)          (e)          P=0.129     |P=0.158      P=0.512      (e)          P=0.240      | 
|LOGISTIC REGRESSION|     P=0.011 *    (e)          (e)          P=0.121     |P=0.150      P=0.511      (e)          P=0.245      | 
|COCH-ARM / FISHERS |     P=0.010 *    (e)          (e)          P=0.117     |P=0.163      P=0.500      (e)          P=0.258      | 
|ORDER RESTRICTED   |     P=0.009 **   (e)          (e)          (e)         |P=0.076      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/47 (4%)    1/47 (2%)    3/48 (6%)    3/46 (7%)   |1/46 (2%)    0/46 (0%)    0/47 (0%)    3/48 (6%)    | 
|POLY-3 RATE (b)    |     2/41.19      1/42.07      3/43.16      3/42.29     |1/41.94      0/43.24      0/42.67      3/42.63      | 
|POLY-3 PERCENT (g) |     4.9%         2.4%         7.0%         7.1%        |2.4%         0.0%         0.0%         7.0%         | 
|TERMINAL (d)       |     1/24 (4%)    1/30 (3%)    2/34 (6%)    1/30 (3%)   |1/33 (3%)    0/35 (0%)    0/34 (0%)    3/34 (9%)    | 
|FIRST INCIDENCE    |     623          733 (T)      698          505         |734 (T)      ---          ---          734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.320      P=0.451N     P=0.615      P=0.551     |P=0.076      P=0.488N     P=0.494N     P=0.315      | 
|POLY 3             |     P=0.285      P=0.493N     P=0.521      P=0.512     |P=0.076      P=0.494N     P=0.497N     P=0.311      | 
|POLY 1.5           |     P=0.278      P=0.496N     P=0.513      P=0.502     |P=0.079      P=0.498N     P=0.498N     P=0.314      | 
|POLY 6             |     P=0.296      P=0.485N     P=0.539      P=0.527     |P=0.074      P=0.488N     P=0.493N     P=0.309      | 
|LOGISTIC REGRESSION|     P=0.261      P=0.502N     P=0.515      P=0.464     |P=0.076      (e)          (e)          P=0.315      | 
|COCH-ARM / FISHERS |     P=0.267      P=0.500N     P=0.510      P=0.490     |P=0.082      P=0.500N     P=0.495N     P=0.325      | 
|ORDER RESTRICTED   |     P=0.383      (e)          (e)          (e)         |P=0.039 *    (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 57      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/48 (0%)    0/47 (0%)   |0/47 (0%)    1/47 (2%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |     0/41.39      0/42.07      0/43.02      0/42.42     |0/42.70      1/43.85      1/43.67      2/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         0.0%         0.0%        |0.0%         2.3%         2.3%         4.7%         | 
|TERMINAL (d)       |     0/24 (0%)    0/30 (0%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    1/36 (3%)    1/35 (3%)    2/34 (6%)    | 
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.158      P=0.517      P=0.512      P=0.245      | 
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.159      P=0.505      P=0.504      P=0.237      | 
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.162      P=0.501      P=0.502      P=0.238      | 
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.158      P=0.512      P=0.509      P=0.236      | 
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.517      P=0.512      P=0.245      | 
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.165      P=0.500      P=0.505      P=0.253      | 
|ORDER RESTRICTED   |     (e)          (e)          (e)          (e)         |P=0.117      (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/48 (0%)    1/47 (2%)    0/48 (0%)    0/47 (0%)   |0/47 (0%)    2/47 (4%)    0/48 (0%)    0/48 (0%)    | 
|POLY-3 RATE (b)    |     0/41.39      1/42.07      0/43.02      0/42.42     |0/42.70      2/43.96      0/43.67      0/42.63      | 
|POLY-3 PERCENT (g) |     0.0%         2.4%         0.0%         0.0%        |0.0%         4.6%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/24 (0%)    1/30 (3%)    0/34 (0%)    0/30 (0%)   |0/33 (0%)    0/36 (0%)    0/35 (0%)    0/34 (0%)    | 
|FIRST INCIDENCE    |     ---          733 (T)      ---          ---         |---          709          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.474N     P=0.545      (e)          (e)         |P=0.324N     P=0.264      (e)          (e)          | 
|POLY 3             |     P=0.494N     P=0.503      (e)          (e)         |P=0.313N     P=0.244      (e)          (e)          | 
|POLY 1.5           |     P=0.498N     P=0.500      (e)          (e)         |P=0.317N     P=0.239      (e)          (e)          | 
|POLY 6             |     P=0.485N     P=0.510      (e)          (e)         |P=0.307N     P=0.251      (e)          (e)          | 
|LOGISTIC REGRESSION|     (e)          P=0.545      (e)          (e)         |P=0.322N     P=0.242      (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.502N     P=0.495      (e)          (e)         |P=0.317N     P=0.247      (e)          (e)          | 
|ORDER RESTRICTED   |     P=0.379N     (e)          (e)          (e)         |P=0.253N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 58      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Cervix                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |5/48 (10%)   5/48 (10%)   2/48 (4%)    5/48 (10%)   | 
|POLY-3 RATE (b)    |                                                        |5/43.70      5/44.68      2/43.67      5/42.63      | 
|POLY-3 PERCENT (g) |                                                        |11.4%        11.2%        4.6%         11.7%        | 
|TERMINAL (d)       |                                                        |4/33 (12%)   5/36 (14%)   2/35 (6%)    5/34 (15%)   | 
|FIRST INCIDENCE    |                                                        |719          734 (T)      734 (T)      734 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.499N     P=0.575N     P=0.194N     P=0.612N     | 
|POLY 3             |                                                        |P=0.516N     P=0.616N     P=0.216N     P=0.615      | 
|POLY 1.5           |                                                        |P=0.510N     P=0.628N     P=0.221N     P=0.619      | 
|POLY 6             |                                                        |P=0.520N     P=0.599N     P=0.207N     P=0.615      | 
|LOGISTIC REGRESSION|                                                        |P=0.511N     P=0.565N     P=0.190N     P=0.629N     | 
|COCH-ARM / FISHERS |                                                        |P=0.500N     P=0.630N     P=0.218N     P=0.630N     | 
|ORDER RESTRICTED   |                                                        |P=0.477N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |3/48 (6%)    3/48 (6%)    4/48 (8%)    7/48 (15%)   | 
|POLY-3 RATE (b)    |                                                        |3/44.13      3/44.68      4/44.02      7/43.16      | 
|POLY-3 PERCENT (g) |                                                        |6.8%         6.7%         9.1%         16.2%        | 
|TERMINAL (d)       |                                                        |2/33 (6%)    3/36 (8%)    2/35 (6%)    6/34 (18%)   | 
|FIRST INCIDENCE    |                                                        |589          734 (T)      657          570          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.073      P=0.627N     P=0.526      P=0.167      | 
|POLY 3             |                                                        |P=0.068      P=0.657N     P=0.499      P=0.147      | 
|POLY 1.5           |                                                        |P=0.071      P=0.661      P=0.493      P=0.150      | 
|POLY 6             |                                                        |P=0.066      P=0.647N     P=0.511      P=0.146      | 
|LOGISTIC REGRESSION|                                                        |P=0.072      P=0.663N     P=0.503      P=0.158      | 
|COCH-ARM / FISHERS |                                                        |P=0.075      P=0.661N     P=0.500      P=0.158      | 
|ORDER RESTRICTED   |                                                        |P=0.103      (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  05/05/03                           EXPERIMENT: 93029 TEST: 03                                            Page 59      
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(F344/NCTR)  -             LEUKOMALACHITE GREEN
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 PPM        91 PPM       272 PPM      543 PPM     |0 PPM        91 PPM       272 PPM      543 PPM      | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |3/48 (6%)    2/48 (4%)    1/48 (2%)    2/48 (4%)    | 
|POLY-3 RATE (b)    |                                                        |3/44.24      2/44.68      1/43.67      2/43.19      | 
|POLY-3 PERCENT (g) |                                                        |6.8%         4.5%         2.3%         4.6%         | 
|TERMINAL (d)       |                                                        |0/33 (0%)    2/36 (6%)    1/35 (3%)    0/34 (0%)    | 
|FIRST INCIDENCE    |                                                        |662          734 (T)      734 (T)      585          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.420N     P=0.471N     P=0.296N     P=0.515N     | 
|POLY 3             |                                                        |P=0.416N     P=0.495N     P=0.310N     P=0.511N     | 
|POLY 1.5           |                                                        |P=0.412N     P=0.501N     P=0.312N     P=0.508N     | 
|POLY 6             |                                                        |P=0.419N     P=0.488N     P=0.306N     P=0.513N     | 
|LOGISTIC REGRESSION|                                                        |P=0.401N     P=0.499N     P=0.298N     P=0.445N     | 
|COCH-ARM / FISHERS |                                                        |P=0.406N     P=0.500N     P=0.308N     P=0.500N     | 
|ORDER RESTRICTED   |                                                        |P=0.364N     (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).