https://ntp.niehs.nih.gov/go/4138

TDMS Study 93005-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/19/03       
EXPERIMENT: 93005 TEST: 04                                                                                     TIME: 07:25:41       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: TROTTER, RONALD                                                                                   CAS: 569-64-2        
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/19/03       
EXPERIMENT: 93005 TEST: 04                                                                                     TIME: 07:25:41       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: TROTTER, RONALD                                                                                   CAS: 569-64-2        
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                     MALACHITE GREEN                                                                              
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Hypertrophy Focal                                                                            
Bone: Sternum                          Fibrous Osteodystrophy                                                                       
Clitoral Gland: Duct                   Cyst                                                                                         
Kidney: Glomerulus                     Amyloid Deposition                                                                           
Kidney: Pelvis                         Dilatation                                                                                   
Kidney: Renal Tubule                   Accumulation, Hyaline Droplet                                                                
Liver                                  Infiltration Cellular Lymphocyte                                                             
                                       Necrosis                                                                                     
Lung                                   Proteinosis                                                                                  
Ovary                                  Atrophy                                                                                      
Pancreas: Acinus                       Atrophy                                                                                      
Salivary Glands: Submandibular Gland   Infiltration Cellular Lymphocyte                                                             
Stomach, Forestomach: Epithelium       Hyperplasia Focal                                                                            
Tongue: Artery                         Inflammation Chronic                                                                         
Urinary Bladder                        Inclusion Body Intracytoplasmic                                                              
                                       Infiltration Cellular Lymphocyte                                                             
===============================================================                                                                     
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN    
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/47 (0%)                1/45 (2%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  0/44.14                  0/46.38                  1/42.40                  3/44.42         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     2.4%                     6.8%            | 
|TERMINAL (d)       |                  0/39 (0%)                0/44 (0%)                1/40 (3%)                2/40 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.019 *                (e)                      P=0.505                  P=0.126         | 
|POLY 3             |                  P=0.018 *                (e)                      P=0.492                  P=0.120         | 
|POLY 1.5           |                  P=0.018 *                (e)                      P=0.491                  P=0.118         | 
|POLY 6             |                  P=0.019 *                (e)                      P=0.495                  P=0.123         | 
|LOGISTIC REGRESSION|                  P=0.020 *                (e)                      P=0.505                  P=0.121         | 
|COCH-ARM / FISHERS |                  P=0.020 *                (e)                      P=0.489                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.021 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex: Subcapsular                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  46/47 (98%)              46/47 (98%)              44/45 (98%)              45/47 (96%)     | 
|POLY-3 RATE (b)    |                  46/46.14                 46/47.00                 44/45.00                 45/45.67        | 
|POLY-3 PERCENT (g) |                  99.7%                    97.9%                    97.8%                    98.5%           | 
|TERMINAL (d)       |                  39/39 (100%)             43/44 (98%)              39/40 (98%)              40/40 (100%)    | 
|FIRST INCIDENCE    |                  562                      644                      226                      318             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.494N                 P=0.104N                 P=0.306N                 P=0.379N        | 
|POLY 3             |                  P=0.538N                 P=0.559N                 P=0.550N                 P=0.753N        | 
|POLY 1.5           |                  P=0.511N                 P=0.640N                 P=0.630N                 P=0.691N        | 
|POLY 6             |                  P=0.597N                 P=0.512N                 P=0.503N                 P=0.907N        | 
|LOGISTIC REGRESSION|                  P=0.601N                 P=0.459N                 P=0.710                  P=0.791         | 
|COCH-ARM / FISHERS |                  P=0.348N                 P=0.753N                 P=0.742N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.396N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                5/48 (10%)               2/48 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  4/45.14                  5/46.93                  2/43.58                  2/45.08         | 
|POLY-3 PERCENT (g) |                  8.9%                     10.7%                    4.6%                     4.4%            | 
|TERMINAL (d)       |                  4/40 (10%)               5/44 (11%)               2/40 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.173N                 P=0.560                  P=0.337N                 P=0.325N        | 
|POLY 3             |                  P=0.178N                 P=0.524                  P=0.353N                 P=0.338N        | 
|POLY 1.5           |                  P=0.179N                 P=0.515                  P=0.352N                 P=0.342N        | 
|POLY 6             |                  P=0.174N                 P=0.535                  P=0.349N                 P=0.331N        | 
|LOGISTIC REGRESSION|                  P=0.173N                 P=0.560                  P=0.337N                 P=0.325N        | 
|COCH-ARM / FISHERS |                  P=0.171N                 P=0.500                  P=0.339N                 P=0.339N        | 
|ORDER RESTRICTED   |                  P=0.261N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                2/48 (4%)                4/48 (8%)                3/48 (6%)       | 
|POLY-3 RATE (b)    |                  0/45.14                  2/46.93                  4/43.58                  3/45.08         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     9.2%                     6.7%            | 
|TERMINAL (d)       |                  0/40 (0%)                2/44 (5%)                4/40 (10%)               3/41 (7%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.110                  P=0.260                  P=0.063                  P=0.126         | 
|POLY 3             |                  P=0.110                  P=0.246                  P=0.056                  P=0.118         | 
|POLY 1.5           |                  P=0.109                  P=0.243                  P=0.056                  P=0.117         | 
|POLY 6             |                  P=0.113                  P=0.250                  P=0.057                  P=0.121         | 
|LOGISTIC REGRESSION|                  (e)                      P=0.260                  P=0.063                  P=0.126         | 
|COCH-ARM / FISHERS |                  P=0.114                  P=0.247                  P=0.059                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.062                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/48 (25%)              14/48 (29%)              5/48 (10%)               5/48 (10%)      | 
|POLY-3 RATE (b)    |                  12/45.14                 14/46.93                 5/43.58                  5/45.08         | 
|POLY-3 PERCENT (g) |                  26.6%                    29.8%                    11.5%                    11.1%           | 
|TERMINAL (d)       |                  12/40 (30%)              14/44 (32%)              5/40 (13%)               5/41 (12%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.010N*                P=0.522                  P=0.052N                 P=0.046N*       | 
|POLY 3             |                  P=0.011N*                P=0.455                  P=0.060N                 P=0.051N        | 
|POLY 1.5           |                  P=0.011N*                P=0.438                  P=0.060N                 P=0.054N        | 
|POLY 6             |                  P=0.010N*                P=0.474                  P=0.057N                 P=0.048N*       | 
|LOGISTIC REGRESSION|                  P=0.010N*                P=0.522                  P=0.052N                 P=0.046N*       | 
|COCH-ARM / FISHERS |                  P=0.011N*                P=0.409                  P=0.053N                 P=0.053N        | 
|ORDER RESTRICTED   |                  P=0.026N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain: Cerebrum                                                                                                                  | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  25/48 (52%)              18/48 (38%)              17/48 (35%)              17/48 (35%)     | 
|POLY-3 RATE (b)    |                  25/46.85                 18/46.99                 17/44.52                 17/45.38        | 
|POLY-3 PERCENT (g) |                  53.4%                    38.3%                    38.2%                    37.5%           | 
|TERMINAL (d)       |                  19/40 (48%)              17/44 (39%)              13/40 (33%)              15/41 (37%)     | 
|FIRST INCIDENCE    |                  562                      711                      568                      673             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.111N                 P=0.067N                 P=0.101N                 P=0.079N        | 
|POLY 3             |                  P=0.115N                 P=0.103N                 P=0.106N                 P=0.091N        | 
|POLY 1.5           |                  P=0.111N                 P=0.103N                 P=0.098N                 P=0.088N        | 
|POLY 6             |                  P=0.116N                 P=0.108N                 P=0.107N                 P=0.095N        | 
|LOGISTIC REGRESSION|                  P=0.102N                 P=0.102N                 P=0.088N                 P=0.078N        | 
|COCH-ARM / FISHERS |                  P=0.090N                 P=0.109N                 P=0.075N                 P=0.075N        | 
|ORDER RESTRICTED   |                  P=0.091N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  44/48 (92%)              47/47 (100%)             45/46 (98%)              44/44 (100%)    | 
|POLY-3 RATE (b)    |                  44/46.93                 47/47.00                 45/45.03                 44/44.00        | 
|POLY-3 PERCENT (g) |                  93.8%                    100.0%                   99.9%                    100.0%          | 
|TERMINAL (d)       |                  38/40 (95%)              43/43 (100%)             40/40 (100%)             39/39 (100%)    | 
|FIRST INCIDENCE    |                  562                      596                      442                      626             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.406                  P=0.594N                 P=0.482                  P=0.511         | 
|POLY 3             |                  P=0.051                  P=0.112                  P=0.124                  P=0.124         | 
|POLY 1.5           |                  P=0.039 *                P=0.088                  P=0.116                  P=0.099         | 
|POLY 6             |                  P=0.066                  P=0.138                  P=0.146                  P=0.150         | 
|LOGISTIC REGRESSION|                  P=0.034 *                P=0.131                  P=0.068                  P=0.148         | 
|COCH-ARM / FISHERS |                  P=0.050                  P=0.061                  P=0.194                  P=0.070         | 
|ORDER RESTRICTED   |                  P=0.007 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral, Lens                                                                                                             | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                2/48 (4%)                5/47 (11%)               2/48 (4%)       | 
|POLY-3 RATE (b)    |                  4/46.17                  2/47.38                  5/45.05                  2/45.08         | 
|POLY-3 PERCENT (g) |                  8.7%                     4.2%                     11.1%                    4.4%            | 
|TERMINAL (d)       |                  1/40 (3%)                1/44 (2%)                1/40 (3%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  562                      596                      444                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.390N                 P=0.317N                 P=0.488                  P=0.338N        | 
|POLY 3             |                  P=0.402N                 P=0.326N                 P=0.485                  P=0.348N        | 
|POLY 1.5           |                  P=0.399N                 P=0.330N                 P=0.482                  P=0.347N        | 
|POLY 6             |                  P=0.404N                 P=0.322N                 P=0.491                  P=0.349N        | 
|LOGISTIC REGRESSION|                  P=0.292N                 P=0.514N                 P=0.574                  P=0.315N        | 
|COCH-ARM / FISHERS |                  P=0.380N                 P=0.339N                 P=0.486                  P=0.339N        | 
|ORDER RESTRICTED   |                  P=0.345N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Lens                                                                                                                        | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               4/48 (8%)                6/47 (13%)               8/48 (17%)      | 
|POLY-3 RATE (b)    |                  5/46.17                  4/47.38                  6/45.05                  8/46.27         | 
|POLY-3 PERCENT (g) |                  10.8%                    8.4%                     13.3%                    17.3%           | 
|TERMINAL (d)       |                  2/40 (5%)                3/44 (7%)                2/40 (5%)                6/41 (15%)      | 
|FIRST INCIDENCE    |                  562                      596                      444                      161             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.154                  P=0.459N                 P=0.489                  P=0.292         | 
|POLY 3             |                  P=0.146                  P=0.484N                 P=0.483                  P=0.277         | 
|POLY 1.5           |                  P=0.147                  P=0.489N                 P=0.480                  P=0.276         | 
|POLY 6             |                  P=0.147                  P=0.479N                 P=0.489                  P=0.279         | 
|LOGISTIC REGRESSION|                  P=0.211                  P=0.640N                 P=0.555                  P=0.319         | 
|COCH-ARM / FISHERS |                  P=0.150                  P=0.500N                 P=0.485                  P=0.276         | 
|ORDER RESTRICTED   |                  P=0.209                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                5/48 (10%)               5/48 (10%)               4/48 (8%)       | 
|POLY-3 RATE (b)    |                  4/45.14                  5/46.93                  5/43.58                  4/45.08         | 
|POLY-3 PERCENT (g) |                  8.9%                     10.7%                    11.5%                    8.9%            | 
|TERMINAL (d)       |                  4/40 (10%)               5/44 (11%)               5/40 (13%)               4/41 (10%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.537N                 P=0.560                  P=0.500                  P=0.631N        | 
|POLY 3             |                  P=0.542N                 P=0.524                  P=0.478                  P=0.642         | 
|POLY 1.5           |                  P=0.544N                 P=0.515                  P=0.480                  P=0.638         | 
|POLY 6             |                  P=0.535N                 P=0.535                  P=0.483                  P=0.636N        | 
|LOGISTIC REGRESSION|                  P=0.537N                 P=0.560                  P=0.500                  P=0.631N        | 
|COCH-ARM / FISHERS |                  P=0.529N                 P=0.500                  P=0.500                  P=0.643N        | 
|ORDER RESTRICTED   |                  P=0.635                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  0/45.14                  0/46.93                  2/43.79                  0/45.08         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/40 (0%)                0/44 (0%)                0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      694                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.586                  (e)                      P=0.245                  (e)             | 
|POLY 3             |                  P=0.580                  (e)                      P=0.230                  (e)             | 
|POLY 1.5           |                  P=0.577                  (e)                      P=0.231                  (e)             | 
|POLY 6             |                  P=0.584                  (e)                      P=0.233                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.586                  (e)                      P=0.235                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.584                  (e)                      P=0.247                  (e)             | 
|ORDER RESTRICTED   |                  P=0.241                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                7/47 (15%)               3/48 (6%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  2/45.14                  7/46.38                  3/43.66                  2/45.07         | 
|POLY-3 PERCENT (g) |                  4.4%                     15.1%                    6.9%                     4.4%            | 
|TERMINAL (d)       |                  2/40 (5%)                7/44 (16%)               2/40 (5%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  707                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.300N                 P=0.105                  P=0.502                  P=0.686N        | 
|POLY 3             |                  P=0.294N                 P=0.085                  P=0.485                  P=0.693         | 
|POLY 1.5           |                  P=0.299N                 P=0.081                  P=0.486                  P=0.690         | 
|POLY 6             |                  P=0.286N                 P=0.091                  P=0.489                  P=0.689N        | 
|LOGISTIC REGRESSION|                  P=0.294N                 P=0.105                  P=0.490                  P=0.686N        | 
|COCH-ARM / FISHERS |                  P=0.302N                 P=0.074                  P=0.500                  P=0.684         | 
|ORDER RESTRICTED   |                  P=0.267N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Glomerulus                                                                                                               | 
|     Amyloid Deposition                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/47 (0%)                0/48 (0%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  0/45.14                  0/46.38                  0/43.58                  2/45.08         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/40 (0%)                0/44 (0%)                0/40 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      723             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.046 *                (e)                      (e)                      P=0.248         | 
|POLY 3             |                  P=0.043 *                (e)                      (e)                      P=0.237         | 
|POLY 1.5           |                  P=0.043 *                (e)                      (e)                      P=0.235         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.240         | 
|LOGISTIC REGRESSION|                  P=0.045 *                (e)                      (e)                      P=0.244         | 
|COCH-ARM / FISHERS |                  P=0.044 *                (e)                      (e)                      P=0.242         | 
|ORDER RESTRICTED   |                  P=0.029 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/47 (0%)                0/48 (0%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/45.43                  0/46.38                  0/43.58                  0/45.07         | 
|POLY-3 PERCENT (g) |                  4.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/40 (3%)                0/44 (0%)                0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  647                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.126N                 P=0.227N                 P=0.245N                 P=0.239N        | 
|POLY 3             |                  P=0.128N                 P=0.233N                 P=0.247N                 P=0.239N        | 
|POLY 1.5           |                  P=0.126N                 P=0.236N                 P=0.245N                 P=0.241N        | 
|POLY 6             |                  P=0.130N                 P=0.229N                 P=0.246N                 P=0.237N        | 
|LOGISTIC REGRESSION|                  P=0.119N                 P=0.278N                 P=0.229N                 P=0.244N        | 
|COCH-ARM / FISHERS |                  P=0.123N                 P=0.253N                 P=0.247N                 P=0.253N        | 
|ORDER RESTRICTED   |                  P=0.030N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                0/47 (0%)                1/48 (2%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  4/46.30                  0/46.38                  1/43.79                  1/45.07         | 
|POLY-3 PERCENT (g) |                  8.6%                     0.0%                     2.3%                     2.2%            | 
|TERMINAL (d)       |                  0/40 (0%)                0/44 (0%)                0/40 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  562                      ---                      673                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.185N                 P=0.061N                 P=0.194N                 P=0.184N        | 
|POLY 3             |                  P=0.187N                 P=0.060N                 P=0.196N                 P=0.187N        | 
|POLY 1.5           |                  P=0.185N                 P=0.061N                 P=0.192N                 P=0.187N        | 
|POLY 6             |                  P=0.188N                 P=0.059N                 P=0.198N                 P=0.188N        | 
|LOGISTIC REGRESSION|                  P=0.161N                 P=0.125N                 P=0.133N                 P=0.183N        | 
|COCH-ARM / FISHERS |                  P=0.180N                 P=0.061N                 P=0.181N                 P=0.187N        | 
|ORDER RESTRICTED   |                  P=0.036N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                1/48 (2%)                3/46 (7%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  1/45.14                  1/46.93                  3/43.32                  0/45.08         | 
|POLY-3 PERCENT (g) |                  2.2%                     2.1%                     6.9%                     0.0%            | 
|TERMINAL (d)       |                  1/40 (3%)                1/44 (2%)                3/40 (8%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.417N                 P=0.740N                 P=0.305                  P=0.495N        | 
|POLY 3             |                  P=0.422N                 P=0.752N                 P=0.291                  P=0.500N        | 
|POLY 1.5           |                  P=0.424N                 P=0.755N                 P=0.289                  P=0.502N        | 
|POLY 6             |                  P=0.418N                 P=0.748N                 P=0.295                  P=0.498N        | 
|LOGISTIC REGRESSION|                  P=0.417N                 P=0.740N                 P=0.305                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.415N                 P=0.753N                 P=0.292                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.224N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                1/48 (2%)                0/46 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  2/45.43                  1/46.93                  0/43.32                  2/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     2.1%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  1/40 (3%)                1/44 (2%)                0/40 (0%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  647                      727 (T)                  ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.581                  P=0.475N                 P=0.245N                 P=0.689N        | 
|POLY 3             |                  P=0.577                  P=0.489N                 P=0.248N                 P=0.691         | 
|POLY 1.5           |                  P=0.578                  P=0.493N                 P=0.249N                 P=0.689         | 
|POLY 6             |                  P=0.578                  P=0.485N                 P=0.246N                 P=0.693N        | 
|LOGISTIC REGRESSION|                  P=0.583                  P=0.531N                 P=0.240N                 P=0.694         | 
|COCH-ARM / FISHERS |                  P=0.585                  P=0.500N                 P=0.258N                 P=0.692N        | 
|ORDER RESTRICTED   |                  P=0.411                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                6/48 (13%)               8/46 (17%)               12/48 (25%)     | 
|POLY-3 RATE (b)    |                  4/45.14                  6/46.93                  8/43.40                  12/45.73        | 
|POLY-3 PERCENT (g) |                  8.9%                     12.8%                    18.4%                    26.2%           | 
|TERMINAL (d)       |                  4/40 (10%)               6/44 (14%)               7/40 (18%)               8/41 (20%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  707                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.014 *                P=0.430                  P=0.179                  P=0.036 *       | 
|POLY 3             |                  P=0.012 *                P=0.394                  P=0.157                  P=0.027 *       | 
|POLY 1.5           |                  P=0.012 *                P=0.385                  P=0.155                  P=0.025 *       | 
|POLY 6             |                  P=0.014 *                P=0.405                  P=0.164                  P=0.030 *       | 
|LOGISTIC REGRESSION|                  P=0.012 *                P=0.430                  P=0.172                  P=0.027 *       | 
|COCH-ARM / FISHERS |                  P=0.013 *                P=0.370                  P=0.157                  P=0.026 *       | 
|ORDER RESTRICTED   |                  P=0.016 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               9/48 (19%)               8/46 (17%)               4/48 (8%)       | 
|POLY-3 RATE (b)    |                  5/45.14                  9/46.93                  8/43.32                  4/45.08         | 
|POLY-3 PERCENT (g) |                  11.1%                    19.2%                    18.5%                    8.9%            | 
|TERMINAL (d)       |                  5/40 (13%)               9/44 (21%)               8/40 (20%)               4/41 (10%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.302N                 P=0.248                  P=0.273                  P=0.484N        | 
|POLY 3             |                  P=0.309N                 P=0.215                  P=0.249                  P=0.501N        | 
|POLY 1.5           |                  P=0.314N                 P=0.207                  P=0.245                  P=0.506N        | 
|POLY 6             |                  P=0.300N                 P=0.224                  P=0.256                  P=0.492N        | 
|LOGISTIC REGRESSION|                  P=0.302N                 P=0.248                  P=0.273                  P=0.484N        | 
|COCH-ARM / FISHERS |                  P=0.301N                 P=0.193                  P=0.249                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.253N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/48 (0%)                0/46 (0%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/45.14                  0/46.93                  0/43.32                  2/45.08         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     4.4%            | 
|TERMINAL (d)       |                  0/40 (0%)                0/44 (0%)                0/40 (0%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.044 *                (e)                      (e)                      P=0.244         | 
|POLY 3             |                  P=0.044 *                (e)                      (e)                      P=0.237         | 
|POLY 1.5           |                  P=0.044 *                (e)                      (e)                      P=0.235         | 
|POLY 6             |                  P=0.044 *                (e)                      (e)                      P=0.240         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      P=0.244         | 
|COCH-ARM / FISHERS |                  P=0.046 *                (e)                      (e)                      P=0.247         | 
|ORDER RESTRICTED   |                  P=0.029 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Tension Lipidosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/48 (21%)              7/48 (15%)               8/46 (17%)               6/48 (13%)      | 
|POLY-3 RATE (b)    |                  10/45.14                 7/46.93                  8/43.84                  6/45.09         | 
|POLY-3 PERCENT (g) |                  22.2%                    14.9%                    18.3%                    13.3%           | 
|TERMINAL (d)       |                  10/40 (25%)              7/44 (16%)               7/40 (18%)               5/41 (12%)      | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  568                      723             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.216N                 P=0.224N                 P=0.399N                 P=0.190N        | 
|POLY 3             |                  P=0.225N                 P=0.266N                 P=0.423N                 P=0.205N        | 
|POLY 1.5           |                  P=0.227N                 P=0.278N                 P=0.434N                 P=0.211N        | 
|POLY 6             |                  P=0.219N                 P=0.254N                 P=0.405N                 P=0.196N        | 
|LOGISTIC REGRESSION|                  P=0.219N                 P=0.224N                 P=0.435N                 P=0.175N        | 
|COCH-ARM / FISHERS |                  P=0.213N                 P=0.297N                 P=0.436N                 P=0.206N        | 
|ORDER RESTRICTED   |                  P=0.210N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                3/48 (6%)                2/48 (4%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/45.14                  3/46.93                  2/43.58                  0/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     6.4%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  2/40 (5%)                3/44 (7%)                2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.130N                 P=0.544                  P=0.695                  P=0.233N        | 
|POLY 3             |                  P=0.132N                 P=0.518                  P=0.681                  P=0.237N        | 
|POLY 1.5           |                  P=0.134N                 P=0.511                  P=0.682                  P=0.239N        | 
|POLY 6             |                  P=0.130N                 P=0.525                  P=0.684                  P=0.234N        | 
|LOGISTIC REGRESSION|                  P=0.130N                 P=0.544                  P=0.695                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.129N                 P=0.500                  P=0.692N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.142N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/48 (13%)               6/48 (13%)               6/48 (13%)               2/48 (4%)       | 
|POLY-3 RATE (b)    |                  6/45.27                  6/46.93                  6/44.36                  2/45.08         | 
|POLY-3 PERCENT (g) |                  13.3%                    12.8%                    13.5%                    4.4%            | 
|TERMINAL (d)       |                  5/40 (13%)               6/44 (14%)               5/40 (13%)               2/41 (5%)       | 
|FIRST INCIDENCE    |                  694                      727 (T)                  442                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.104N                 P=0.552N                 P=0.619N                 P=0.128N        | 
|POLY 3             |                  P=0.106N                 P=0.595N                 P=0.606                  P=0.134N        | 
|POLY 1.5           |                  P=0.107N                 P=0.604N                 P=0.605                  P=0.136N        | 
|POLY 6             |                  P=0.103N                 P=0.585N                 P=0.614                  P=0.130N        | 
|LOGISTIC REGRESSION|                  P=0.103N                 P=0.573N                 P=0.619                  P=0.128N        | 
|COCH-ARM / FISHERS |                  P=0.100N                 P=0.621N                 P=0.621N                 P=0.134N        | 
|ORDER RESTRICTED   |                  P=0.142N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Proteinosis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/48 (6%)                0/48 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  3/45.14                  0/46.93                  0/43.58                  0/45.08         | 
|POLY-3 PERCENT (g) |                  6.7%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  3/40 (8%)                0/44 (0%)                0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.053N                 P=0.105N                 P=0.121N                 P=0.117N        | 
|POLY 3             |                  P=0.053N                 P=0.112N                 P=0.125N                 P=0.119N        | 
|POLY 1.5           |                  P=0.052N                 P=0.114N                 P=0.125N                 P=0.120N        | 
|POLY 6             |                  P=0.054N                 P=0.109N                 P=0.123N                 P=0.116N        | 
|LOGISTIC REGRESSION|                  P=0.053N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.052N                 P=0.121N                 P=0.121N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.008N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                3/48 (6%)                0/48 (0%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  1/45.14                  3/46.93                  0/43.58                  1/45.08         | 
|POLY-3 PERCENT (g) |                  2.2%                     6.4%                     0.0%                     2.2%            | 
|TERMINAL (d)       |                  1/40 (3%)                3/44 (7%)                0/40 (0%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.391N                 P=0.340                  P=0.500N                 P=0.756N        | 
|POLY 3             |                  P=0.390N                 P=0.320                  P=0.507N                 P=0.760         | 
|POLY 1.5           |                  P=0.391N                 P=0.314                  P=0.506N                 P=0.758         | 
|POLY 6             |                  P=0.385N                 P=0.326                  P=0.505N                 P=0.758N        | 
|LOGISTIC REGRESSION|                  P=0.391N                 P=0.340                  (e)                      P=0.756N        | 
|COCH-ARM / FISHERS |                  P=0.387N                 P=0.308                  P=0.500N                 P=0.753N        | 
|ORDER RESTRICTED   |                  P=0.280N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                1/48 (2%)                2/47 (4%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  2/45.14                  1/46.93                  2/42.71                  1/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     2.1%                     4.7%                     2.2%            | 
|TERMINAL (d)       |                  2/40 (5%)                1/44 (2%)                2/40 (5%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.455N                 P=0.467N                 P=0.695                  P=0.491N        | 
|POLY 3             |                  P=0.462N                 P=0.486N                 P=0.674                  P=0.500N        | 
|POLY 1.5           |                  P=0.462N                 P=0.491N                 P=0.675                  P=0.503N        | 
|POLY 6             |                  P=0.460N                 P=0.481N                 P=0.678                  P=0.496N        | 
|LOGISTIC REGRESSION|                  P=0.455N                 P=0.467N                 P=0.695                  P=0.491N        | 
|COCH-ARM / FISHERS |                  P=0.452N                 P=0.500N                 P=0.684                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.444N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node, Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/45 (18%)               8/46 (17%)               5/44 (11%)               5/46 (11%)      | 
|POLY-3 RATE (b)    |                  8/43.54                  8/45.23                  5/41.45                  5/44.16         | 
|POLY-3 PERCENT (g) |                  18.4%                    17.7%                    12.1%                    11.3%           | 
|TERMINAL (d)       |                  8/39 (21%)               7/42 (17%)               5/39 (13%)               4/40 (10%)      | 
|FIRST INCIDENCE    |                  727 (T)                  644                      727 (T)                  704             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.174N                 P=0.546N                 P=0.273N                 P=0.258N        | 
|POLY 3             |                  P=0.177N                 P=0.575N                 P=0.307N                 P=0.266N        | 
|POLY 1.5           |                  P=0.176N                 P=0.582N                 P=0.306N                 P=0.267N        | 
|POLY 6             |                  P=0.174N                 P=0.564N                 P=0.302N                 P=0.260N        | 
|LOGISTIC REGRESSION|                  P=0.174N                 P=0.581N                 P=0.273N                 P=0.252N        | 
|COCH-ARM / FISHERS |                  P=0.167N                 P=0.589N                 P=0.290N                 P=0.261N        | 
|ORDER RESTRICTED   |                  P=0.282N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Lumbar                                                                                                               | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/13 (31%)               4/13 (31%)               2/6 (33%)                1/9 (11%)       | 
|POLY-3 RATE (b)    |                  4/12.47                  4/12.23                  2/5.58                   1/6.87          | 
|POLY-3 PERCENT (g) |                  32.1%                    32.7%                    35.8%                    14.6%           | 
|TERMINAL (d)       |                  4/10 (40%)               4/10 (40%)               2/3 (67%)                1/5 (20%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.379N                 P=0.672                  P=0.442                  P=0.426N        | 
|POLY 3             |                  P=0.314N                 P=0.650                  P=0.643                  P=0.389N        | 
|POLY 1.5           |                  P=0.298N                 P=0.653                  P=0.649                  P=0.372N        | 
|POLY 6             |                  P=0.316N                 P=0.648                  P=0.631                  P=0.389N        | 
|LOGISTIC REGRESSION|                  P=0.379N                 P=0.672                  P=0.442                  P=0.426N        | 
|COCH-ARM / FISHERS |                  P=0.210N                 P=0.664N                 P=0.652                  P=0.293N        | 
|ORDER RESTRICTED   |                  P=0.346N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mediastinal                                                                                                          | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/13 (0%)                2/13 (15%)               0/6 (0%)                 0/9 (0%)        | 
|POLY-3 RATE (b)    |                  0/12.47                  2/12.23                  0/5.58                   0/6.87          | 
|POLY-3 PERCENT (g) |                  0.0%                     16.4%                    0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/10 (0%)                2/10 (20%)               0/3 (0%)                 0/5 (0%)        | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.558N                 P=0.234                  (e)                      (e)             | 
|POLY 3             |                  P=0.515N                 P=0.225                  (e)                      (e)             | 
|POLY 1.5           |                  P=0.507N                 P=0.227                  (e)                      (e)             | 
|POLY 6             |                  P=0.521N                 P=0.223                  (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      P=0.234                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.475N                 P=0.240                  (e)                      (e)             | 
|ORDER RESTRICTED   |                  P=0.374                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/13 (15%)               1/13 (8%)                2/6 (33%)                1/9 (11%)       | 
|POLY-3 RATE (b)    |                  2/12.47                  1/12.23                  2/5.58                   1/6.87          | 
|POLY-3 PERCENT (g) |                  16.0%                    8.2%                     35.8%                    14.6%           | 
|TERMINAL (d)       |                  2/10 (20%)               1/10 (10%)               2/3 (67%)                1/5 (20%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.448                  P=0.500N                 P=0.215                  P=0.746         | 
|POLY 3             |                  P=0.474                  P=0.507N                 P=0.377                  P=0.701N        | 
|POLY 1.5           |                  P=0.492                  P=0.504N                 P=0.384                  P=0.690N        | 
|POLY 6             |                  P=0.474                  P=0.509N                 P=0.365                  P=0.703N        | 
|LOGISTIC REGRESSION|                  P=0.448                  P=0.500N                 P=0.215                  P=0.746         | 
|COCH-ARM / FISHERS |                  P=0.596                  P=0.500N                 P=0.373                  P=0.642N        | 
|ORDER RESTRICTED   |                  P=0.419                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/2 (100%)               3/5 (60%)                1/1 (100%)               0/0 (0%)        | 
|POLY-3 RATE (b)    |                  2/2.00                   3/5.00                   1/1.00                   0/0.00          | 
|POLY-3 PERCENT (g) |                  100.0%                   60.0%                    100.0%                   0.0%            | 
|TERMINAL (d)       |                  2/2 (100%)               3/5 (60%)                1/1 (100%)               0/0 (0%)        | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.861N                 P=0.451N                 (e)                      (e)             | 
|POLY 3             |                  (e)                      P=0.451N                 (e)                      (e)             | 
|POLY 1.5           |                  (e)                      P=0.451N                 (e)                      (e)             | 
|POLY 6             |                  (e)                      P=0.451N                 (e)                      (e)             | 
|LOGISTIC REGRESSION|                  P=0.861N                 P=0.451N                 (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.877N                 P=0.476N                 (e)                      (e)             | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  28/48 (58%)              33/46 (72%)              36/46 (78%)              36/45 (80%)     | 
|POLY-3 RATE (b)    |                  28/45.53                 33/45.38                 36/43.73                 36/43.42        | 
|POLY-3 PERCENT (g) |                  61.5%                    72.7%                    82.3%                    82.9%           | 
|TERMINAL (d)       |                  26/40 (65%)              33/43 (77%)              33/40 (83%)              34/39 (87%)     | 
|FIRST INCIDENCE    |                  676                      727 (T)                  673                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.015 *                P=0.339                  P=0.061                  P=0.036 *       | 
|POLY 3             |                  P=0.012 *                P=0.176                  P=0.021 *                P=0.018 *       | 
|POLY 1.5           |                  P=0.012 *                P=0.157                  P=0.021 *                P=0.017 *       | 
|POLY 6             |                  P=0.012 *                P=0.198                  P=0.025 *                P=0.020 *       | 
|LOGISTIC REGRESSION|                  P=0.014 *                P=0.286                  P=0.031 *                P=0.028 *       | 
|COCH-ARM / FISHERS |                  P=0.017 *                P=0.126                  P=0.032 *                P=0.021 *       | 
|ORDER RESTRICTED   |                  P=0.011 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  19/48 (40%)              21/46 (46%)              14/46 (30%)              13/45 (29%)     | 
|POLY-3 RATE (b)    |                  19/45.91                 21/45.70                 14/43.32                 13/43.50        | 
|POLY-3 PERCENT (g) |                  41.4%                    46.0%                    32.3%                    29.9%           | 
|TERMINAL (d)       |                  16/40 (40%)              19/43 (44%)              14/40 (35%)              11/39 (28%)     | 
|FIRST INCIDENCE    |                  599                      659                      727 (T)                  633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.080N                 P=0.534                  P=0.199N                 P=0.163N        | 
|POLY 3             |                  P=0.080N                 P=0.410                  P=0.252N                 P=0.180N        | 
|POLY 1.5           |                  P=0.082N                 P=0.388                  P=0.252N                 P=0.187N        | 
|POLY 6             |                  P=0.077N                 P=0.434                  P=0.250N                 P=0.171N        | 
|LOGISTIC REGRESSION|                  P=0.079N                 P=0.401                  P=0.229N                 P=0.183N        | 
|COCH-ARM / FISHERS |                  P=0.081N                 P=0.350                  P=0.238N                 P=0.193N        | 
|ORDER RESTRICTED   |                  P=0.137N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/48 (6%)                0/46 (0%)                1/46 (2%)                1/45 (2%)       | 
|POLY-3 RATE (b)    |                  3/45.14                  0/45.38                  1/43.32                  1/43.07         | 
|POLY-3 PERCENT (g) |                  6.7%                     0.0%                     2.3%                     2.3%            | 
|TERMINAL (d)       |                  3/40 (8%)                0/43 (0%)                1/40 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.327N                 P=0.109N                 P=0.305N                 P=0.314N        | 
|POLY 3             |                  P=0.338N                 P=0.118N                 P=0.320N                 P=0.322N        | 
|POLY 1.5           |                  P=0.335N                 P=0.121N                 P=0.322N                 P=0.326N        | 
|POLY 6             |                  P=0.340N                 P=0.114N                 P=0.315N                 P=0.317N        | 
|LOGISTIC REGRESSION|                  P=0.327N                 (e)                      P=0.305N                 P=0.314N        | 
|COCH-ARM / FISHERS |                  P=0.329N                 P=0.129N                 P=0.325N                 P=0.333N        | 
|ORDER RESTRICTED   |                  P=0.111N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary: Bilateral                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/48 (8%)                3/46 (7%)                3/46 (7%)                2/45 (4%)       | 
|POLY-3 RATE (b)    |                  4/45.91                  3/45.38                  3/43.32                  2/43.07         | 
|POLY-3 PERCENT (g) |                  8.7%                     6.6%                     6.9%                     4.6%            | 
|TERMINAL (d)       |                  1/40 (3%)                3/43 (7%)                3/40 (8%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  599                      727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.294N                 P=0.466N                 P=0.505N                 P=0.343N        | 
|POLY 3             |                  P=0.307N                 P=0.506N                 P=0.532N                 P=0.367N        | 
|POLY 1.5           |                  P=0.306N                 P=0.512N                 P=0.531N                 P=0.368N        | 
|POLY 6             |                  P=0.308N                 P=0.501N                 P=0.531N                 P=0.366N        | 
|LOGISTIC REGRESSION|                  P=0.298N                 P=0.602N                 P=0.518N                 P=0.370N        | 
|COCH-ARM / FISHERS |                  P=0.299N                 P=0.524N                 P=0.524N                 P=0.370N        | 
|ORDER RESTRICTED   |                  P=0.356N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary: Germinal Epithelium                                                                                                       | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/48 (0%)                0/46 (0%)                2/46 (4%)                0/45 (0%)       | 
|POLY-3 RATE (b)    |                  0/45.14                  0/45.38                  2/43.32                  0/43.07         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/40 (0%)                0/43 (0%)                2/40 (5%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.573                  (e)                      P=0.238                  (e)             | 
|POLY 3             |                  P=0.576                  (e)                      P=0.228                  (e)             | 
|POLY 1.5           |                  P=0.574                  (e)                      P=0.227                  (e)             | 
|POLY 6             |                  P=0.579                  (e)                      P=0.231                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.238                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.572                  (e)                      P=0.237                  (e)             | 
|ORDER RESTRICTED   |                  P=0.239                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/47 (13%)               4/47 (9%)                2/44 (5%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  6/45.00                  4/46.38                  2/41.53                  3/45.07         | 
|POLY-3 PERCENT (g) |                  13.3%                    8.6%                     4.8%                     6.7%            | 
|TERMINAL (d)       |                  6/40 (15%)               4/44 (9%)                2/40 (5%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.173N                 P=0.310N                 P=0.133N                 P=0.229N        | 
|POLY 3             |                  P=0.182N                 P=0.351N                 P=0.160N                 P=0.241N        | 
|POLY 1.5           |                  P=0.181N                 P=0.359N                 P=0.161N                 P=0.244N        | 
|POLY 6             |                  P=0.180N                 P=0.339N                 P=0.154N                 P=0.235N        | 
|LOGISTIC REGRESSION|                  P=0.173N                 P=0.310N                 P=0.133N                 P=0.229N        | 
|COCH-ARM / FISHERS |                  P=0.176N                 P=0.370N                 P=0.156N                 P=0.243N        | 
|ORDER RESTRICTED   |                  P=0.151N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                0/47 (0%)                0/44 (0%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/45.00                  0/46.38                  0/41.53                  0/45.07         | 
|POLY-3 PERCENT (g) |                  4.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/40 (5%)                0/44 (0%)                0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.123N                 P=0.218N                 P=0.238N                 P=0.233N        | 
|POLY 3             |                  P=0.127N                 P=0.231N                 P=0.255N                 P=0.237N        | 
|POLY 1.5           |                  P=0.126N                 P=0.234N                 P=0.256N                 P=0.238N        | 
|POLY 6             |                  P=0.129N                 P=0.226N                 P=0.252N                 P=0.234N        | 
|LOGISTIC REGRESSION|                  P=0.123N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.125N                 P=0.247N                 P=0.264N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.029N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/48 (2%)                2/47 (4%)                5/46 (11%)               0/45 (0%)       | 
|POLY-3 RATE (b)    |                  1/45.35                  2/45.93                  5/41.58                  0/42.08         | 
|POLY-3 PERCENT (g) |                  2.2%                     4.4%                     12.0%                    0.0%            | 
|TERMINAL (d)       |                  0/40 (0%)                2/43 (5%)                5/38 (13%)               0/38 (0%)       | 
|FIRST INCIDENCE    |                  673                      727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.437N                 P=0.519                  P=0.095                  P=0.500N        | 
|POLY 3             |                  P=0.442N                 P=0.504                  P=0.082                  P=0.515N        | 
|POLY 1.5           |                  P=0.443N                 P=0.500                  P=0.084                  P=0.516N        | 
|POLY 6             |                  P=0.438N                 P=0.509                  P=0.083                  P=0.513N        | 
|LOGISTIC REGRESSION|                  P=0.440N                 P=0.481                  P=0.086                  P=0.501N        | 
|COCH-ARM / FISHERS |                  P=0.431N                 P=0.492                  P=0.092                  P=0.516N        | 
|ORDER RESTRICTED   |                  P=0.135N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Parotid Gland                                                                                                   | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/48 (10%)               12/48 (25%)              4/48 (8%)                5/48 (10%)      | 
|POLY-3 RATE (b)    |                  5/45.43                  12/46.93                 4/44.36                  5/45.08         | 
|POLY-3 PERCENT (g) |                  11.0%                    25.6%                    9.0%                     11.1%           | 
|TERMINAL (d)       |                  4/40 (10%)               12/44 (27%)              3/40 (8%)                5/41 (12%)      | 
|FIRST INCIDENCE    |                  647                      727 (T)                  442                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.244N                 P=0.082                  P=0.505N                 P=0.617N        | 
|POLY 3             |                  P=0.242N                 P=0.060                  P=0.515N                 P=0.625         | 
|POLY 1.5           |                  P=0.245N                 P=0.058                  P=0.515N                 P=0.622         | 
|POLY 6             |                  P=0.236N                 P=0.063                  P=0.510N                 P=0.630N        | 
|LOGISTIC REGRESSION|                  P=0.244N                 P=0.067                  P=0.481N                 P=0.631N        | 
|COCH-ARM / FISHERS |                  P=0.235N                 P=0.053                  P=0.500N                 P=0.630N        | 
|ORDER RESTRICTED   |                  P=0.198N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Submandibular Gland                                                                                             | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  35/48 (73%)              28/48 (58%)              28/48 (58%)              28/48 (58%)     | 
|POLY-3 RATE (b)    |                  35/46.41                 28/46.93                 28/44.44                 28/45.89        | 
|POLY-3 PERCENT (g) |                  75.4%                    59.7%                    63.0%                    61.0%           | 
|TERMINAL (d)       |                  32/40 (80%)              28/44 (64%)              26/40 (65%)              24/41 (59%)     | 
|FIRST INCIDENCE    |                  562                      727 (T)                  442                      626             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.154N                 P=0.024N*                P=0.099N                 P=0.087N        | 
|POLY 3             |                  P=0.157N                 P=0.076N                 P=0.142N                 P=0.101N        | 
|POLY 1.5           |                  P=0.163N                 P=0.082N                 P=0.133N                 P=0.108N        | 
|POLY 6             |                  P=0.138N                 P=0.072N                 P=0.140N                 P=0.085N        | 
|LOGISTIC REGRESSION|                  P=0.164N                 P=0.053N                 P=0.140N                 P=0.102N        | 
|COCH-ARM / FISHERS |                  P=0.136N                 P=0.098N                 P=0.098N                 P=0.098N        | 
|ORDER RESTRICTED   |                  P=0.108N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spinal Cord: Thoracic, Axon                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/48 (27%)              14/48 (29%)              19/48 (40%)              19/48 (40%)     | 
|POLY-3 RATE (b)    |                  13/45.46                 14/47.49                 19/43.66                 19/45.09        | 
|POLY-3 PERCENT (g) |                  28.6%                    29.5%                    43.5%                    42.1%           | 
|TERMINAL (d)       |                  11/40 (28%)              12/44 (27%)              18/40 (45%)              18/41 (44%)     | 
|FIRST INCIDENCE    |                  676                      644                      707                      723             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.080                  P=0.569N                 P=0.142                  P=0.163         | 
|POLY 3             |                  P=0.064                  P=0.553                  P=0.105                  P=0.128         | 
|POLY 1.5           |                  P=0.066                  P=0.533                  P=0.110                  P=0.127         | 
|POLY 6             |                  P=0.063                  P=0.576                  P=0.106                  P=0.133         | 
|LOGISTIC REGRESSION|                  P=0.074                  P=0.530                  P=0.119                  P=0.153         | 
|COCH-ARM / FISHERS |                  P=0.084                  P=0.500                  P=0.139                  P=0.139         | 
|ORDER RESTRICTED   |                  P=0.120                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/47 (19%)               8/47 (17%)               3/45 (7%)                5/47 (11%)      | 
|POLY-3 RATE (b)    |                  9/45.00                  8/46.63                  3/42.45                  5/45.18         | 
|POLY-3 PERCENT (g) |                  20.0%                    17.2%                    7.1%                     11.1%           | 
|TERMINAL (d)       |                  7/40 (18%)               7/44 (16%)               3/40 (8%)                3/41 (7%)       | 
|FIRST INCIDENCE    |                  676                      659                      727 (T)                  704             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.107N                 P=0.422N                 P=0.065N                 P=0.186N        | 
|POLY 3             |                  P=0.106N                 P=0.468N                 P=0.073N                 P=0.190N        | 
|POLY 1.5           |                  P=0.105N                 P=0.480N                 P=0.073N                 P=0.192N        | 
|POLY 6             |                  P=0.106N                 P=0.455N                 P=0.071N                 P=0.187N        | 
|LOGISTIC REGRESSION|                  P=0.104N                 P=0.495N                 P=0.072N                 P=0.188N        | 
|COCH-ARM / FISHERS |                  P=0.102N                 P=0.500N                 P=0.070N                 P=0.193N        | 
|ORDER RESTRICTED   |                  P=0.102N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/47 (13%)               6/47 (13%)               7/45 (16%)               2/47 (4%)       | 
|POLY-3 RATE (b)    |                  6/44.68                  6/46.38                  7/42.45                  2/45.07         | 
|POLY-3 PERCENT (g) |                  13.4%                    12.9%                    16.5%                    4.4%            | 
|TERMINAL (d)       |                  6/40 (15%)               6/44 (14%)               7/40 (18%)               2/41 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.114N                 P=0.553N                 P=0.500                  P=0.126N        | 
|POLY 3             |                  P=0.116N                 P=0.594N                 P=0.460                  P=0.130N        | 
|POLY 1.5           |                  P=0.117N                 P=0.604N                 P=0.458                  P=0.132N        | 
|POLY 6             |                  P=0.115N                 P=0.582N                 P=0.468                  P=0.127N        | 
|LOGISTIC REGRESSION|                  P=0.114N                 P=0.553N                 P=0.500                  P=0.126N        | 
|COCH-ARM / FISHERS |                  P=0.115N                 P=0.621N                 P=0.466                  P=0.134N        | 
|ORDER RESTRICTED   |                  P=0.113N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                3/47 (6%)                2/46 (4%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  2/45.00                  3/46.38                  2/43.32                  1/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     6.5%                     4.6%                     2.2%            | 
|TERMINAL (d)       |                  2/40 (5%)                3/44 (7%)                2/40 (5%)                1/41 (2%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.308N                 P=0.544                  P=0.695                  P=0.491N        | 
|POLY 3             |                  P=0.311N                 P=0.514                  P=0.680                  P=0.499N        | 
|POLY 1.5           |                  P=0.311N                 P=0.508                  P=0.680                  P=0.500N        | 
|POLY 6             |                  P=0.308N                 P=0.522                  P=0.684                  P=0.495N        | 
|LOGISTIC REGRESSION|                  P=0.308N                 P=0.544                  P=0.695                  P=0.491N        | 
|COCH-ARM / FISHERS |                  P=0.299N                 P=0.500                  P=0.683                  P=0.492N        | 
|ORDER RESTRICTED   |                  P=0.363N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia Diffuse                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                2/47 (4%)                1/46 (2%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/45.29                  2/46.38                  1/43.32                  0/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     4.3%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  1/40 (3%)                2/44 (5%)                1/40 (3%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  647                      727 (T)                  727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.126N                 P=0.665N                 P=0.505N                 P=0.239N        | 
|POLY 3             |                  P=0.127N                 P=0.685N                 P=0.516N                 P=0.238N        | 
|POLY 1.5           |                  P=0.127N                 P=0.689N                 P=0.515N                 P=0.238N        | 
|POLY 6             |                  P=0.127N                 P=0.680N                 P=0.514N                 P=0.237N        | 
|LOGISTIC REGRESSION|                  P=0.119N                 P=0.646                  P=0.498N                 P=0.214N        | 
|COCH-ARM / FISHERS |                  P=0.121N                 P=0.692N                 P=0.508N                 P=0.242N        | 
|ORDER RESTRICTED   |                  P=0.156N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach, Forestomach: Epithelium                                                                                                 | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/47 (23%)              8/47 (17%)               4/46 (9%)                7/48 (15%)      | 
|POLY-3 RATE (b)    |                  11/45.00                 8/46.44                  4/43.32                  7/45.99         | 
|POLY-3 PERCENT (g) |                  24.5%                    17.2%                    9.2%                     15.2%           | 
|TERMINAL (d)       |                  11/40 (28%)              7/44 (16%)               4/40 (10%)               6/41 (15%)      | 
|FIRST INCIDENCE    |                  727 (T)                  711                      727 (T)                  318             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.163N                 P=0.228N                 P=0.044N*                P=0.200N        | 
|POLY 3             |                  P=0.155N                 P=0.278N                 P=0.051N                 P=0.200N        | 
|POLY 1.5           |                  P=0.156N                 P=0.290N                 P=0.051N                 P=0.206N        | 
|POLY 6             |                  P=0.152N                 P=0.260N                 P=0.048N*                P=0.191N        | 
|LOGISTIC REGRESSION|                  P=0.151N                 P=0.230N                 P=0.044N*                P=0.194N        | 
|COCH-ARM / FISHERS |                  P=0.148N                 P=0.304N                 P=0.049N*                P=0.202N        | 
|ORDER RESTRICTED   |                  P=0.090N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/43 (9%)                2/44 (5%)                3/43 (7%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  4/41.73                  2/43.38                  3/40.21                  3/44.42         | 
|POLY-3 PERCENT (g) |                  9.6%                     4.6%                     7.5%                     6.8%            | 
|TERMINAL (d)       |                  3/37 (8%)                2/41 (5%)                2/37 (5%)                2/40 (5%)       | 
|FIRST INCIDENCE    |                  599                      727 (T)                  442                      633             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.496N                 P=0.298N                 P=0.509N                 P=0.470N        | 
|POLY 3             |                  P=0.484N                 P=0.319N                 P=0.520N                 P=0.466N        | 
|POLY 1.5           |                  P=0.482N                 P=0.323N                 P=0.518N                 P=0.466N        | 
|POLY 6             |                  P=0.483N                 P=0.315N                 P=0.517N                 P=0.462N        | 
|LOGISTIC REGRESSION|                  P=0.417N                 P=0.395N                 P=0.422N                 P=0.431N        | 
|COCH-ARM / FISHERS |                  P=0.465N                 P=0.327N                 P=0.500N                 P=0.450N        | 
|ORDER RESTRICTED   |                  P=0.432N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Ectopic Parathyroid Gland                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/43 (7%)                1/44 (2%)                2/43 (5%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  3/41.29                  1/43.38                  2/39.44                  3/44.08         | 
|POLY-3 PERCENT (g) |                  7.3%                     2.3%                     5.1%                     6.8%            | 
|TERMINAL (d)       |                  3/37 (8%)                1/41 (2%)                2/37 (5%)                3/40 (8%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.483                  P=0.269N                 P=0.500N                 P=0.627N        | 
|POLY 3             |                  P=0.483                  P=0.288N                 P=0.521N                 P=0.632N        | 
|POLY 1.5           |                  P=0.486                  P=0.292N                 P=0.519N                 P=0.632N        | 
|POLY 6             |                  P=0.483                  P=0.282N                 P=0.518N                 P=0.628N        | 
|LOGISTIC REGRESSION|                  P=0.483                  P=0.269N                 P=0.500N                 P=0.627N        | 
|COCH-ARM / FISHERS |                  P=0.503                  P=0.299N                 P=0.500N                 P=0.618N        | 
|ORDER RESTRICTED   |                  P=0.475N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/43 (7%)                5/44 (11%)               6/43 (14%)               2/47 (4%)       | 
|POLY-3 RATE (b)    |                  3/41.29                  5/43.38                  6/39.44                  2/44.08         | 
|POLY-3 PERCENT (g) |                  7.3%                     11.5%                    15.2%                    4.5%            | 
|TERMINAL (d)       |                  3/37 (8%)                5/41 (12%)               6/37 (16%)               2/40 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  727 (T)                  727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.332N                 P=0.413                  P=0.240                  P=0.464N        | 
|POLY 3             |                  P=0.333N                 P=0.384                  P=0.218                  P=0.470N        | 
|POLY 1.5           |                  P=0.332N                 P=0.377                  P=0.221                  P=0.471N        | 
|POLY 6             |                  P=0.330N                 P=0.393                  P=0.221                  P=0.467N        | 
|LOGISTIC REGRESSION|                  P=0.332N                 P=0.413                  P=0.240                  P=0.464N        | 
|COCH-ARM / FISHERS |                  P=0.310N                 P=0.370                  P=0.242                  P=0.457N        | 
|ORDER RESTRICTED   |                  P=0.225N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Ultimobranchial Cyst                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/46 (0%)                2/46 (4%)                2/48 (4%)       | 
|POLY-3 RATE (b)    |                  0/44.14                  0/45.38                  2/43.84                  2/45.08         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     4.4%            | 
|TERMINAL (d)       |                  0/39 (0%)                0/43 (0%)                1/40 (3%)                2/41 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      568                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.084                  (e)                      P=0.238                  P=0.249         | 
|POLY 3             |                  P=0.083                  (e)                      P=0.236                  P=0.242         | 
|POLY 1.5           |                  P=0.083                  (e)                      P=0.233                  P=0.240         | 
|POLY 6             |                  P=0.084                  (e)                      P=0.240                  P=0.245         | 
|LOGISTIC REGRESSION|                  P=0.094                  (e)                      P=0.251                  P=0.249         | 
|COCH-ARM / FISHERS |                  P=0.087                  (e)                      P=0.242                  P=0.253         | 
|ORDER RESTRICTED   |                  P=0.115                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                2/46 (4%)                3/46 (7%)                1/48 (2%)       | 
|POLY-3 RATE (b)    |                  2/44.14                  2/45.38                  3/43.52                  1/45.17         | 
|POLY-3 PERCENT (g) |                  4.5%                     4.4%                     6.9%                     2.2%            | 
|TERMINAL (d)       |                  2/39 (5%)                2/43 (5%)                2/40 (5%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  673                      704             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.399N                 P=0.659N                 P=0.507                  P=0.480N        | 
|POLY 3             |                  P=0.402N                 P=0.684N                 P=0.494                  P=0.492N        | 
|POLY 1.5           |                  P=0.403N                 P=0.690N                 P=0.490                  P=0.495N        | 
|POLY 6             |                  P=0.397N                 P=0.676N                 P=0.502                  P=0.486N        | 
|LOGISTIC REGRESSION|                  P=0.400N                 P=0.659N                 P=0.490                  P=0.492N        | 
|COCH-ARM / FISHERS |                  P=0.394N                 P=0.683                  P=0.490                  P=0.492N        | 
|ORDER RESTRICTED   |                  P=0.389N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tongue: Artery                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/48 (4%)                0/48 (0%)                0/48 (0%)                0/48 (0%)       | 
|POLY-3 RATE (b)    |                  2/45.14                  0/46.93                  0/43.58                  0/45.08         | 
|POLY-3 PERCENT (g) |                  4.4%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/40 (5%)                0/44 (0%)                0/40 (0%)                0/41 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.123N                 P=0.218N                 P=0.238N                 P=0.233N        | 
|POLY 3             |                  P=0.126N                 P=0.229N                 P=0.245N                 P=0.237N        | 
|POLY 1.5           |                  P=0.125N                 P=0.232N                 P=0.244N                 P=0.239N        | 
|POLY 6             |                  P=0.128N                 P=0.225N                 P=0.243N                 P=0.234N        | 
|LOGISTIC REGRESSION|                  P=0.123N                 (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.122N                 P=0.247N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.029N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inclusion Body Intracytoplasmic                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/47 (15%)               15/46 (33%)              34/45 (76%)              39/48 (81%)     | 
|POLY-3 RATE (b)    |                  7/45.00                  15/45.38                 34/43.09                 39/45.08        | 
|POLY-3 PERCENT (g) |                  15.6%                    33.1%                    78.9%                    86.5%           | 
|TERMINAL (d)       |                  7/40 (18%)               15/43 (35%)              33/39 (85%)              39/41 (95%)     | 
|FIRST INCIDENCE    |                  727 (T)                  727 (T)                  442                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P=0.062                  P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P=0.043 *                P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P=0.040 *                P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P=0.048 *                P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P=0.062                  P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P=0.038 *                P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
       Date:  06/19/03                           EXPERIMENT: 93005 TEST: 04                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                      MALACHITE GREEN     
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Infiltration Cellular Lymphocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  36/47 (77%)              34/46 (74%)              33/45 (73%)              25/48 (52%)     | 
|POLY-3 RATE (b)    |                  36/45.94                 34/45.38                 33/43.04                 25/45.65        | 
|POLY-3 PERCENT (g) |                  78.4%                    74.9%                    76.7%                    54.8%           | 
|TERMINAL (d)       |                  33/40 (83%)              34/43 (79%)              31/39 (80%)              23/41 (56%)     | 
|FIRST INCIDENCE    |                  599                      727 (T)                  568                      626             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.007N**               P=0.194N                 P=0.397N                 P=0.012N*       | 
|POLY 3             |                  P=0.006N**               P=0.444N                 P=0.525N                 P=0.012N*       | 
|POLY 1.5           |                  P=0.006N**               P=0.457N                 P=0.520N                 P=0.013N*       | 
|POLY 6             |                  P=0.005N**               P=0.426N                 P=0.505N                 P=0.010N*       | 
|LOGISTIC REGRESSION|                  P=0.007N**               P=0.315N                 P=0.530N                 P=0.014N*       | 
|COCH-ARM / FISHERS |                  P=0.004N**               P=0.476N                 P=0.452N                 P=0.011N*       | 
|ORDER RESTRICTED   |                  P=0.006N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    100 PPM                  225 PPM                  450 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  42/48 (88%)              46/48 (96%)              44/47 (94%)              42/48 (88%)     | 
|POLY-3 RATE (b)    |                  42/45.97                 46/47.94                 44/46.10                 42/45.38        | 
|POLY-3 PERCENT (g) |                  91.4%                    96.0%                    95.5%                    92.6%           | 
|TERMINAL (d)       |                  39/40 (98%)              43/44 (98%)              39/40 (98%)              40/41 (98%)     | 
|FIRST INCIDENCE    |                  599                      596                      226                      673             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.459N                 P=0.635N                 P=0.362                  P=0.498N        | 
|POLY 3             |                  P=0.584N                 P=0.298                  P=0.342                  P=0.576         | 
|POLY 1.5           |                  P=0.563N                 P=0.218                  P=0.296                  P=0.552         | 
|POLY 6             |                  P=0.579N                 P=0.422                  P=0.429                  P=0.634         | 
|LOGISTIC REGRESSION|                  P=0.567                  P=0.301                  P=0.152                  P=0.586N        | 
|COCH-ARM / FISHERS |                  P=0.398N                 P=0.134                  P=0.254                  P=0.621N        | 
|ORDER RESTRICTED   |                  P=0.382                  (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).