National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/3954

TDMS Study 93029-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:10:49       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:10:49       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  LEUKOMALACHITE GREEN                                                                            
===============================================================                                                                     
Female Mice                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Gland: Cortex, Subcapsular     Hyperplasia                                                                                  
Bone: Femur                            Fibrous Osteodystrophy                                                                       
Gallbladder: Mucosa                    Hyperplasia Focal                                                                            
Harderian Gland                        Hyperplasia                                                                                  
Liver                                  Infiltration Cellular Lymphocytic                                                            
Lymph Node: Mandibular                 Hyperplasia Lymphoid                                                                         
Lymph Node: Renal                      Hyperplasia Lymphoid                                                                         
Ovary                                  Cyst                                                                                         
                                       Thrombosis                                                                                   
Skeletal Muscle                        Mineralization                                                                               
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Hyperplasia Lymphoid                                                                         
Urinary Bladder                        Inclusion Body Intracytoplasmic                                                              
                                       Infiltration Cellular Lymphocytic                                                            
Vagina: Epithelium                     Hyperplasia                                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/46 (7%)                1/48 (2%)                1/47 (2%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  3/42.55                  1/46.24                  1/43.97                  1/44.65         | 
|POLY-3 PERCENT (g) |                  7.1%                     2.2%                     2.3%                     2.2%            | 
|TERMINAL (d)       |                  2/37 (5%)                1/41 (2%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  639                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.244N                 P=0.276N                 P=0.295N                 P=0.293N        | 
|POLY 3             |                  P=0.248N                 P=0.276N                 P=0.293N                 P=0.288N        | 
|POLY 1.5           |                  P=0.247N                 P=0.278N                 P=0.293N                 P=0.288N        | 
|POLY 6             |                  P=0.249N                 P=0.275N                 P=0.295N                 P=0.289N        | 
|LOGISTIC REGRESSION|                  P=0.242N                 P=0.288N                 P=0.294N                 P=0.294N        | 
|COCH-ARM / FISHERS |                  P=0.245N                 P=0.292N                 P=0.300N                 P=0.300N        | 
|ORDER RESTRICTED   |                  P=0.169N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/46 (4%)                0/48 (0%)                2/47 (4%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/42.21                  0/46.24                  2/43.97                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.7%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                2/39 (5%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  ---                      733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.255N                 P=0.216N                 P=0.676N                 P=0.227N        | 
|POLY 3             |                  P=0.259N                 P=0.217N                 P=0.679N                 P=0.225N        | 
|POLY 1.5           |                  P=0.258N                 P=0.219N                 P=0.680N                 P=0.225N        | 
|POLY 6             |                  P=0.260N                 P=0.216N                 P=0.679N                 P=0.224N        | 
|LOGISTIC REGRESSION|                  P=0.255N                 (e)                      P=0.676N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.258N                 P=0.237N                 P=0.683N                 P=0.242N        | 
|ORDER RESTRICTED   |                  P=0.107N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex                                                                                                            | 
|     Hypertrophy Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/46 (4%)                2/48 (4%)                2/47 (4%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/42.21                  2/46.26                  2/44.05                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.7%                     4.3%                     4.5%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                1/41 (2%)                1/39 (3%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  729                      714                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.156N                 P=0.654N                 P=0.675N                 P=0.227N        | 
|POLY 3             |                  P=0.155N                 P=0.661N                 P=0.679N                 P=0.225N        | 
|POLY 1.5           |                  P=0.155N                 P=0.663N                 P=0.679N                 P=0.225N        | 
|POLY 6             |                  P=0.155N                 P=0.658N                 P=0.678N                 P=0.224N        | 
|LOGISTIC REGRESSION|                  P=0.153N                 P=0.651N                 P=0.680N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.159N                 P=0.675N                 P=0.683N                 P=0.242N        | 
|ORDER RESTRICTED   |                  P=0.177N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Gland: Cortex, Subcapsular                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  42/46 (91%)              47/48 (98%)              46/47 (98%)              47/47 (100%)    | 
|POLY-3 RATE (b)    |                  42/43.70                 47/47.52                 46/47.00                 47/47.00        | 
|POLY-3 PERCENT (g) |                  96.1%                    98.9%                    97.9%                    100.0%          | 
|TERMINAL (d)       |                  36/37 (97%)              41/41 (100%)             38/39 (97%)              39/39 (100%)    | 
|FIRST INCIDENCE    |                  518                      498                      193                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.264                  P=0.555                  P=0.410                  P=0.335         | 
|POLY 3             |                  P=0.192                  P=0.419                  P=0.553                  P=0.262         | 
|POLY 1.5           |                  P=0.137                  P=0.383                  P=0.463                  P=0.192         | 
|POLY 6             |                  P=0.255                  P=0.415                  P=0.623                  P=0.324         | 
|LOGISTIC REGRESSION|                  P=0.068                  P=0.443                  P=0.226                  P=0.150         | 
|COCH-ARM / FISHERS |                  P=0.036 *                P=0.168                  P=0.174                  P=0.056         | 
|ORDER RESTRICTED   |                  P=0.099                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow: Myeloid Cell                                                                                                        | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/46 (9%)                1/48 (2%)                4/47 (9%)                6/46 (13%)      | 
|POLY-3 RATE (b)    |                  4/43.50                  1/46.34                  4/45.04                  6/45.12         | 
|POLY-3 PERCENT (g) |                  9.2%                     2.2%                     8.9%                     13.3%           | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                1/39 (3%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  688                      708                      498                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.155                  P=0.154N                 P=0.619N                 P=0.409         | 
|POLY 3             |                  P=0.139                  P=0.160N                 P=0.624N                 P=0.393         | 
|POLY 1.5           |                  P=0.137                  P=0.161N                 P=0.626N                 P=0.387         | 
|POLY 6             |                  P=0.144                  P=0.159N                 P=0.621N                 P=0.402         | 
|LOGISTIC REGRESSION|                  P=0.114                  P=0.168N                 P=0.636N                 P=0.345         | 
|COCH-ARM / FISHERS |                  P=0.132                  P=0.168N                 P=0.631N                 P=0.370         | 
|ORDER RESTRICTED   |                  P=0.148                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Femur                                                                                                                      | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/47 (17%)               2/48 (4%)                5/47 (11%)               3/47 (6%)       | 
|POLY-3 RATE (b)    |                  8/43.40                  2/46.24                  5/43.97                  3/44.65         | 
|POLY-3 PERCENT (g) |                  18.4%                    4.3%                     11.4%                    6.7%            | 
|TERMINAL (d)       |                  7/37 (19%)               2/41 (5%)                5/39 (13%)               3/39 (8%)       | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.142N                 P=0.034N*                P=0.246N                 P=0.087N        | 
|POLY 3             |                  P=0.152N                 P=0.035N*                P=0.266N                 P=0.089N        | 
|POLY 1.5           |                  P=0.151N                 P=0.036N*                P=0.266N                 P=0.089N        | 
|POLY 6             |                  P=0.152N                 P=0.034N*                P=0.268N                 P=0.089N        | 
|LOGISTIC REGRESSION|                  P=0.142N                 P=0.036N*                P=0.261N                 P=0.088N        | 
|COCH-ARM / FISHERS |                  P=0.153N                 P=0.042N*                P=0.276N                 P=0.099N        | 
|ORDER RESTRICTED   |                  P=0.048N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                3/48 (6%)                1/47 (2%)                5/47 (11%)      | 
|POLY-3 RATE (b)    |                  1/43.21                  3/46.24                  1/43.97                  5/44.68         | 
|POLY-3 PERCENT (g) |                  2.3%                     6.5%                     2.3%                     11.2%           | 
|TERMINAL (d)       |                  1/37 (3%)                3/41 (7%)                1/39 (3%)                4/39 (10%)      | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  724             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.083                  P=0.342                  P=0.750N                 P=0.117         | 
|POLY 3             |                  P=0.082                  P=0.330                  P=0.757N                 P=0.109         | 
|POLY 1.5           |                  P=0.082                  P=0.327                  P=0.757N                 P=0.109         | 
|POLY 6             |                  P=0.082                  P=0.332                  P=0.757N                 P=0.110         | 
|LOGISTIC REGRESSION|                  P=0.085                  P=0.342                  P=0.750N                 P=0.115         | 
|COCH-ARM / FISHERS |                  P=0.079                  P=0.316                  P=0.753N                 P=0.102         | 
|ORDER RESTRICTED   |                  P=0.051                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone: Sternum                                                                                                                    | 
|     Fibrous Osteodystrophy                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  26/47 (55%)              21/48 (44%)              19/47 (40%)              21/47 (45%)     | 
|POLY-3 RATE (b)    |                  26/43.35                 21/46.26                 19/43.97                 21/44.65        | 
|POLY-3 PERCENT (g) |                  60.0%                    45.4%                    43.2%                    47.0%           | 
|TERMINAL (d)       |                  25/37 (68%)              20/41 (49%)              19/39 (49%)              21/39 (54%)     | 
|FIRST INCIDENCE    |                  695                      729                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.167N                 P=0.082N                 P=0.053N                 P=0.117N        | 
|POLY 3             |                  P=0.200N                 P=0.119N                 P=0.084N                 P=0.155N        | 
|POLY 1.5           |                  P=0.200N                 P=0.127N                 P=0.087N                 P=0.160N        | 
|POLY 6             |                  P=0.199N                 P=0.111N                 P=0.083N                 P=0.151N        | 
|LOGISTIC REGRESSION|                  P=0.145N                 P=0.079N                 P=0.066N                 P=0.100N        | 
|COCH-ARM / FISHERS |                  P=0.223N                 P=0.178N                 P=0.108N                 P=0.205N        | 
|ORDER RESTRICTED   |                  P=0.126N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain: Cerebrum                                                                                                                  | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/47 (32%)              18/48 (38%)              21/47 (45%)              21/47 (45%)     | 
|POLY-3 RATE (b)    |                  15/44.05                 18/47.50                 21/44.32                 21/45.49        | 
|POLY-3 PERCENT (g) |                  34.1%                    37.9%                    47.4%                    46.2%           | 
|TERMINAL (d)       |                  13/37 (35%)              15/41 (37%)              19/39 (49%)              19/39 (49%)     | 
|FIRST INCIDENCE    |                  518                      498                      675                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.142                  P=0.467                  P=0.192                  P=0.198         | 
|POLY 3             |                  P=0.121                  P=0.435                  P=0.144                  P=0.170         | 
|POLY 1.5           |                  P=0.125                  P=0.421                  P=0.148                  P=0.170         | 
|POLY 6             |                  P=0.115                  P=0.448                  P=0.139                  P=0.167         | 
|LOGISTIC REGRESSION|                  P=0.122                  P=0.371                  P=0.156                  P=0.162         | 
|COCH-ARM / FISHERS |                  P=0.113                  P=0.361                  P=0.144                  P=0.144         | 
|ORDER RESTRICTED   |                  P=0.173                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland: Duct                                                                                                             | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  44/45 (98%)              46/46 (100%)             41/44 (93%)              45/45 (100%)    | 
|POLY-3 RATE (b)    |                  44/45.00                 46/46.00                 41/43.02                 45/45.00        | 
|POLY-3 PERCENT (g) |                  97.8%                    100.0%                   95.3%                    100.0%          | 
|TERMINAL (d)       |                  35/36 (97%)              40/40 (100%)             35/37 (95%)              38/38 (100%)    | 
|FIRST INCIDENCE    |                  122                      590                      620                      553             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.450N                 P=0.350N                 P=0.234N                 P=0.466N        | 
|POLY 3             |                  P=0.477                  P=0.496                  P=0.480N                 P=0.500         | 
|POLY 1.5           |                  P=0.482                  P=0.496                  P=0.453N                 P=0.500         | 
|POLY 6             |                  P=0.477                  P=0.496                  P=0.484N                 P=0.500         | 
|LOGISTIC REGRESSION|                  P=0.616                  (e)                      P=0.266N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.518                  P=0.495                  P=0.300N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.320                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Bilateral, Lens                                                                                                             | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/47 (9%)                5/48 (10%)               3/47 (6%)                7/47 (15%)      | 
|POLY-3 RATE (b)    |                  4/44.84                  5/46.74                  3/44.10                  7/46.53         | 
|POLY-3 PERCENT (g) |                  8.9%                     10.7%                    6.8%                     15.0%           | 
|TERMINAL (d)       |                  0/37 (0%)                3/41 (7%)                2/39 (5%)                3/39 (8%)       | 
|FIRST INCIDENCE    |                  225                      590                      700                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.240                  P=0.547                  P=0.488N                 P=0.296         | 
|POLY 3             |                  P=0.231                  P=0.526                  P=0.509N                 P=0.283         | 
|POLY 1.5           |                  P=0.228                  P=0.525                  P=0.504N                 P=0.279         | 
|POLY 6             |                  P=0.234                  P=0.526                  P=0.514N                 P=0.287         | 
|LOGISTIC REGRESSION|                  P=0.152                  P=0.364                  P=0.548N                 P=0.132         | 
|COCH-ARM / FISHERS |                  P=0.218                  P=0.514                  P=0.500N                 P=0.261         | 
|ORDER RESTRICTED   |                  P=0.265                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Eye: Lens                                                                                                                        | 
|     Cataract                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/47 (19%)               9/48 (19%)               7/47 (15%)               11/47 (23%)     | 
|POLY-3 RATE (b)    |                  9/46.63                  9/46.74                  7/44.27                  11/46.53        | 
|POLY-3 PERCENT (g) |                  19.3%                    19.3%                    15.8%                    23.6%           | 
|TERMINAL (d)       |                  2/37 (5%)                7/41 (17%)               5/39 (13%)               7/39 (18%)      | 
|FIRST INCIDENCE    |                  122                      590                      690                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.380                  P=0.526N                 P=0.375N                 P=0.450         | 
|POLY 3             |                  P=0.346                  P=0.600N                 P=0.437N                 P=0.399         | 
|POLY 1.5           |                  P=0.346                  P=0.594N                 P=0.424N                 P=0.400         | 
|POLY 6             |                  P=0.345                  P=0.597                  P=0.450N                 P=0.398         | 
|LOGISTIC REGRESSION|                  P=0.275                  P=0.443                  P=0.453N                 P=0.246         | 
|COCH-ARM / FISHERS |                  P=0.347                  P=0.584N                 P=0.392N                 P=0.401         | 
|ORDER RESTRICTED   |                  P=0.401                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Gallbladder: Mucosa                                                                                                              | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/44 (0%)                0/47 (0%)                0/44 (0%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  0/42.02                  0/45.24                  0/41.05                  2/44.22         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     4.5%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/40 (0%)                0/37 (0%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.047 *                (e)                      (e)                      P=0.250         | 
|POLY 3             |                  P=0.046 *                (e)                      (e)                      P=0.249         | 
|POLY 1.5           |                  P=0.046 *                (e)                      (e)                      P=0.249         | 
|POLY 6             |                  P=0.046 *                (e)                      (e)                      P=0.248         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      P=0.250         | 
|COCH-ARM / FISHERS |                  P=0.047 *                (e)                      (e)                      P=0.258         | 
|ORDER RESTRICTED   |                  P=0.033 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                1/48 (2%)                1/47 (2%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  1/46.24                  1/44.05                  3/45.28         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.2%                     2.3%                     6.6%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      733 (T)                  714                      553             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.062                  P=0.520                  P=0.510                  P=0.137         | 
|POLY 3             |                  P=0.057                  P=0.514                  P=0.504                  P=0.127         | 
|POLY 1.5           |                  P=0.057                  P=0.512                  P=0.504                  P=0.126         | 
|POLY 6             |                  P=0.058                  P=0.515                  P=0.504                  P=0.129         | 
|LOGISTIC REGRESSION|                  P=0.048 *                P=0.520                  P=0.502                  P=0.096         | 
|COCH-ARM / FISHERS |                  P=0.054                  P=0.505                  P=0.500                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.042 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Harderian Gland                                                                                                                  | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/47 (9%)                9/48 (19%)               8/47 (17%)               5/47 (11%)      | 
|POLY-3 RATE (b)    |                  4/43.21                  9/46.63                  8/44.88                  5/44.65         | 
|POLY-3 PERCENT (g) |                  9.3%                     19.3%                    17.8%                    11.2%           | 
|TERMINAL (d)       |                  4/37 (11%)               7/41 (17%)               4/39 (10%)               5/39 (13%)      | 
|FIRST INCIDENCE    |                  733 (T)                  675                      620                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.498N                 P=0.163                  P=0.208                  P=0.533         | 
|POLY 3             |                  P=0.496N                 P=0.146                  P=0.195                  P=0.521         | 
|POLY 1.5           |                  P=0.497N                 P=0.142                  P=0.190                  P=0.519         | 
|POLY 6             |                  P=0.494N                 P=0.152                  P=0.203                  P=0.523         | 
|LOGISTIC REGRESSION|                  P=0.509N                 P=0.142                  P=0.181                  P=0.533         | 
|COCH-ARM / FISHERS |                  P=0.519N                 P=0.124                  P=0.177                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.289                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Ileum                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/43 (2%)                1/47 (2%)                3/47 (6%)                1/43 (2%)       | 
|POLY-3 RATE (b)    |                  1/41.15                  1/45.26                  3/43.97                  1/42.53         | 
|POLY-3 PERCENT (g) |                  2.4%                     2.2%                     6.8%                     2.4%            | 
|TERMINAL (d)       |                  1/37 (3%)                1/41 (2%)                3/39 (8%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.557                  P=0.739N                 P=0.324                  P=0.750N        | 
|POLY 3             |                  P=0.560                  P=0.739N                 P=0.329                  P=0.753N        | 
|POLY 1.5           |                  P=0.555                  P=0.738N                 P=0.333                  P=0.754N        | 
|POLY 6             |                  P=0.566                  P=0.740N                 P=0.325                  P=0.751N        | 
|LOGISTIC REGRESSION|                  P=0.557                  P=0.739N                 P=0.324                  P=0.750N        | 
|COCH-ARM / FISHERS |                  P=0.542                  P=0.730N                 P=0.343                  P=0.753N        | 
|ORDER RESTRICTED   |                  P=0.452                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum                                                                                                         | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/43 (0%)                0/47 (0%)                2/47 (4%)                1/43 (2%)       | 
|POLY-3 RATE (b)    |                  0/41.15                  0/45.26                  2/43.97                  1/42.53         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     2.4%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                2/39 (5%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.241                  (e)                      P=0.250                  P=0.511         | 
|POLY 3             |                  P=0.242                  (e)                      P=0.252                  P=0.507         | 
|POLY 1.5           |                  P=0.239                  (e)                      P=0.254                  P=0.505         | 
|POLY 6             |                  P=0.246                  (e)                      P=0.249                  P=0.508         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.250                  P=0.511         | 
|COCH-ARM / FISHERS |                  P=0.229                  (e)                      P=0.270                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.180                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infarct                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                0/48 (0%)                1/47 (2%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  2/43.21                  0/46.24                  1/43.97                  1/44.65         | 
|POLY-3 PERCENT (g) |                  4.6%                     0.0%                     2.3%                     2.2%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.508N                 P=0.216N                 P=0.482N                 P=0.482N        | 
|POLY 3             |                  P=0.521N                 P=0.222N                 P=0.494N                 P=0.489N        | 
|POLY 1.5           |                  P=0.520N                 P=0.224N                 P=0.494N                 P=0.489N        | 
|POLY 6             |                  P=0.523N                 P=0.221N                 P=0.494N                 P=0.487N        | 
|LOGISTIC REGRESSION|                  P=0.508N                 (e)                      P=0.482N                 P=0.482N        | 
|COCH-ARM / FISHERS |                  P=0.517N                 P=0.242N                 P=0.500N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.258N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/47 (19%)               5/48 (10%)               15/47 (32%)              11/47 (23%)     | 
|POLY-3 RATE (b)    |                  9/43.21                  5/46.34                  15/44.83                 11/44.65        | 
|POLY-3 PERCENT (g) |                  20.8%                    10.8%                    33.5%                    24.6%           | 
|TERMINAL (d)       |                  9/37 (24%)               4/41 (10%)               13/39 (33%)              11/39 (28%)     | 
|FIRST INCIDENCE    |                  733 (T)                  708                      498                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.167                  P=0.140N                 P=0.150                  P=0.451         | 
|POLY 3             |                  P=0.153                  P=0.155N                 P=0.137                  P=0.433         | 
|POLY 1.5           |                  P=0.155                  P=0.159N                 P=0.133                  P=0.430         | 
|POLY 6             |                  P=0.152                  P=0.150N                 P=0.141                  P=0.436         | 
|LOGISTIC REGRESSION|                  P=0.158                  P=0.143N                 P=0.126                  P=0.451         | 
|COCH-ARM / FISHERS |                  P=0.149                  P=0.181N                 P=0.118                  P=0.401         | 
|ORDER RESTRICTED   |                  P=0.099                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                2/48 (4%)                3/47 (6%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  1/43.21                  2/46.24                  3/43.97                  1/44.65         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.3%                     6.8%                     2.2%            | 
|TERMINAL (d)       |                  1/37 (3%)                2/41 (5%)                3/39 (8%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.566N                 P=0.536                  P=0.324                  P=0.750N        | 
|POLY 3             |                  P=0.566N                 P=0.524                  P=0.312                  P=0.753N        | 
|POLY 1.5           |                  P=0.566N                 P=0.521                  P=0.311                  P=0.754N        | 
|POLY 6             |                  P=0.565N                 P=0.526                  P=0.311                  P=0.752N        | 
|LOGISTIC REGRESSION|                  P=0.566N                 P=0.536                  P=0.324                  P=0.750N        | 
|COCH-ARM / FISHERS |                  P=0.577N                 P=0.508                  P=0.308                  P=0.753N        | 
|ORDER RESTRICTED   |                  P=0.466N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Pelvis                                                                                                                   | 
|     Dilatation                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                1/48 (2%)                0/47 (0%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.35                  1/46.41                  0/43.97                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.6%                     2.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  695                      690                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.098N                 P=0.464N                 P=0.231N                 P=0.226N        | 
|POLY 3             |                  P=0.102N                 P=0.476N                 P=0.234N                 P=0.231N        | 
|POLY 1.5           |                  P=0.102N                 P=0.479N                 P=0.234N                 P=0.231N        | 
|POLY 6             |                  P=0.103N                 P=0.474N                 P=0.234N                 P=0.230N        | 
|LOGISTIC REGRESSION|                  P=0.102N                 P=0.497N                 P=0.235N                 P=0.234N        | 
|COCH-ARM / FISHERS |                  P=0.101N                 P=0.492N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.070N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Accumulation, Hyaline Droplet                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                2/48 (4%)                1/47 (2%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  1/43.34                  2/46.41                  1/44.10                  3/45.55         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.3%                     2.3%                     6.6%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  700                      690                      700                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.263                  P=0.539                  P=0.751N                 P=0.343         | 
|POLY 3             |                  P=0.252                  P=0.524                  P=0.757N                 P=0.323         | 
|POLY 1.5           |                  P=0.250                  P=0.521                  P=0.757N                 P=0.321         | 
|POLY 6             |                  P=0.253                  P=0.526                  P=0.757N                 P=0.326         | 
|LOGISTIC REGRESSION|                  P=0.206                  P=0.505                  P=0.762                  P=0.236         | 
|COCH-ARM / FISHERS |                  P=0.238                  P=0.508                  P=0.753N                 P=0.308         | 
|ORDER RESTRICTED   |                  P=0.240                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Basophilic Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                2/48 (4%)                0/47 (0%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  1/43.38                  2/46.34                  0/43.97                  3/44.65         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.3%                     0.0%                     6.7%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                3/39 (8%)       | 
|FIRST INCIDENCE    |                  688                      709                      ---                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.259                  P=0.537                  P=0.495N                 P=0.325         | 
|POLY 3             |                  P=0.250                  P=0.523                  P=0.497N                 P=0.316         | 
|POLY 1.5           |                  P=0.251                  P=0.521                  P=0.497N                 P=0.316         | 
|POLY 6             |                  P=0.250                  P=0.525                  P=0.498N                 P=0.316         | 
|LOGISTIC REGRESSION|                  P=0.250                  P=0.507                  P=0.503N                 P=0.314         | 
|COCH-ARM / FISHERS |                  P=0.246                  P=0.508                  P=0.500N                 P=0.308         | 
|ORDER RESTRICTED   |                  P=0.193                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                2/48 (4%)                3/47 (6%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  2/43.35                  2/46.56                  3/44.53                  3/45.52         | 
|POLY-3 PERCENT (g) |                  4.6%                     4.3%                     6.7%                     6.6%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                1/39 (3%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  695                      675                      620                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.382                  P=0.655N                 P=0.518                  P=0.526         | 
|POLY 3             |                  P=0.382                  P=0.668N                 P=0.512                  P=0.522         | 
|POLY 1.5           |                  P=0.378                  P=0.671N                 P=0.510                  P=0.518         | 
|POLY 6             |                  P=0.386                  P=0.664N                 P=0.515                  P=0.528         | 
|LOGISTIC REGRESSION|                  P=0.330                  P=0.697                  P=0.496                  P=0.461         | 
|COCH-ARM / FISHERS |                  P=0.364                  P=0.684N                 P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.514                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/47 (17%)               2/48 (4%)                2/47 (4%)                8/47 (17%)      | 
|POLY-3 RATE (b)    |                  8/43.40                  2/46.24                  2/43.97                  8/44.65         | 
|POLY-3 PERCENT (g) |                  18.4%                    4.3%                     4.6%                     17.9%           | 
|TERMINAL (d)       |                  7/37 (19%)               2/41 (5%)                2/39 (5%)                8/39 (21%)      | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.368                  P=0.034N*                P=0.041N*                P=0.566N        | 
|POLY 3             |                  P=0.345                  P=0.035N*                P=0.042N*                P=0.584N        | 
|POLY 1.5           |                  P=0.347                  P=0.036N*                P=0.042N*                P=0.584N        | 
|POLY 6             |                  P=0.343                  P=0.034N*                P=0.042N*                P=0.584N        | 
|LOGISTIC REGRESSION|                  P=0.368                  P=0.036N*                P=0.044N*                P=0.572N        | 
|COCH-ARM / FISHERS |                  P=0.351                  P=0.042N*                P=0.045N*                P=0.608N        | 
|ORDER RESTRICTED   |                  P=0.116N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation Focal Chronic                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/47 (32%)              13/48 (27%)              16/47 (34%)              11/47 (23%)     | 
|POLY-3 RATE (b)    |                  15/43.21                 13/46.24                 16/43.97                 11/44.96        | 
|POLY-3 PERCENT (g) |                  34.7%                    28.1%                    36.4%                    24.5%           | 
|TERMINAL (d)       |                  15/37 (41%)              13/41 (32%)              16/39 (41%)              10/39 (26%)     | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.225N                 P=0.284N                 P=0.575                  P=0.193N        | 
|POLY 3             |                  P=0.234N                 P=0.329N                 P=0.524                  P=0.206N        | 
|POLY 1.5           |                  P=0.239N                 P=0.338N                 P=0.523                  P=0.212N        | 
|POLY 6             |                  P=0.227N                 P=0.320N                 P=0.525                  P=0.197N        | 
|LOGISTIC REGRESSION|                  P=0.221N                 P=0.284N                 P=0.575                  P=0.203N        | 
|COCH-ARM / FISHERS |                  P=0.262N                 P=0.385N                 P=0.500                  P=0.245N        | 
|ORDER RESTRICTED   |                  P=0.238N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Tension Lipidosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  10/47 (21%)              12/48 (25%)              9/47 (19%)               9/47 (19%)      | 
|POLY-3 RATE (b)    |                  10/43.21                 12/46.93                 9/43.97                  9/44.65         | 
|POLY-3 PERCENT (g) |                  23.1%                    25.6%                    20.5%                    20.2%           | 
|TERMINAL (d)       |                  10/37 (27%)              11/41 (27%)              9/39 (23%)               9/39 (23%)      | 
|FIRST INCIDENCE    |                  733 (T)                  498                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.327N                 P=0.511                  P=0.448N                 P=0.448N        | 
|POLY 3             |                  P=0.344N                 P=0.491                  P=0.483N                 P=0.468N        | 
|POLY 1.5           |                  P=0.343N                 P=0.478                  P=0.484N                 P=0.471N        | 
|POLY 6             |                  P=0.345N                 P=0.504                  P=0.483N                 P=0.464N        | 
|LOGISTIC REGRESSION|                  P=0.340N                 P=0.464                  P=0.448N                 P=0.448N        | 
|COCH-ARM / FISHERS |                  P=0.358N                 P=0.426                  P=0.500N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.502N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                1/48 (2%)                0/47 (0%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.21                  1/46.34                  0/43.97                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.6%                     2.2%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  708                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.097N                 P=0.459N                 P=0.227N                 P=0.227N        | 
|POLY 3             |                  P=0.102N                 P=0.476N                 P=0.233N                 P=0.230N        | 
|POLY 1.5           |                  P=0.102N                 P=0.478N                 P=0.233N                 P=0.230N        | 
|POLY 6             |                  P=0.103N                 P=0.473N                 P=0.233N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.099N                 P=0.477N                 (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.101N                 P=0.492N                 P=0.247N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.070N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/47 (6%)                1/48 (2%)                1/47 (2%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  3/43.21                  1/46.24                  1/43.97                  1/44.65         | 
|POLY-3 PERCENT (g) |                  6.9%                     2.2%                     2.3%                     2.2%            | 
|TERMINAL (d)       |                  3/37 (8%)                1/41 (2%)                1/39 (3%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.241N                 P=0.269N                 P=0.286N                 P=0.286N        | 
|POLY 3             |                  P=0.252N                 P=0.281N                 P=0.299N                 P=0.294N        | 
|POLY 1.5           |                  P=0.252N                 P=0.284N                 P=0.299N                 P=0.295N        | 
|POLY 6             |                  P=0.253N                 P=0.279N                 P=0.299N                 P=0.292N        | 
|LOGISTIC REGRESSION|                  P=0.241N                 P=0.269N                 P=0.286N                 P=0.286N        | 
|COCH-ARM / FISHERS |                  P=0.250N                 P=0.301N                 P=0.308N                 P=0.308N        | 
|ORDER RESTRICTED   |                  P=0.174N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                2/48 (4%)                0/47 (0%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  1/43.21                  2/46.24                  0/43.97                  2/44.65         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.3%                     0.0%                     4.5%            | 
|TERMINAL (d)       |                  1/37 (3%)                2/41 (5%)                0/39 (0%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  ---                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.486                  P=0.536                  P=0.489N                 P=0.518         | 
|POLY 3             |                  P=0.485                  P=0.524                  P=0.496N                 P=0.511         | 
|POLY 1.5           |                  P=0.485                  P=0.521                  P=0.497N                 P=0.511         | 
|POLY 6             |                  P=0.485                  P=0.526                  P=0.496N                 P=0.513         | 
|LOGISTIC REGRESSION|                  P=0.486                  P=0.536                  (e)                      P=0.518         | 
|COCH-ARM / FISHERS |                  P=0.477                  P=0.508                  P=0.500N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.421                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/47 (28%)              7/48 (15%)               9/47 (19%)               12/47 (26%)     | 
|POLY-3 RATE (b)    |                  13/43.89                 7/46.34                  9/44.53                  12/45.02        | 
|POLY-3 PERCENT (g) |                  29.6%                    15.1%                    20.2%                    26.7%           | 
|TERMINAL (d)       |                  10/37 (27%)              6/41 (15%)               7/39 (18%)               10/39 (26%)     | 
|FIRST INCIDENCE    |                  639                      708                      620                      647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.495                  P=0.072N                 P=0.209N                 P=0.443N        | 
|POLY 3             |                  P=0.472                  P=0.079N                 P=0.219N                 P=0.470N        | 
|POLY 1.5           |                  P=0.473                  P=0.079N                 P=0.219N                 P=0.469N        | 
|POLY 6             |                  P=0.471                  P=0.079N                 P=0.221N                 P=0.473N        | 
|LOGISTIC REGRESSION|                  P=0.479                  P=0.079N                 P=0.221N                 P=0.468N        | 
|COCH-ARM / FISHERS |                  P=0.463                  P=0.095N                 P=0.233N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.248N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Leukocytosis                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                2/48 (4%)                0/47 (0%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  2/46.94                  0/43.97                  1/45.14         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     0.0%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      590                      ---                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.555                  P=0.255                  (e)                      P=0.504         | 
|POLY 3             |                  P=0.575                  P=0.256                  (e)                      P=0.509         | 
|POLY 1.5           |                  P=0.572                  P=0.253                  (e)                      P=0.507         | 
|POLY 6             |                  P=0.579                  P=0.260                  (e)                      P=0.511         | 
|LOGISTIC REGRESSION|                  P=0.490                  P=0.170                  (e)                      P=0.419         | 
|COCH-ARM / FISHERS |                  P=0.558                  P=0.253                  (e)                      P=0.500         | 
|ORDER RESTRICTED   |                  P=0.333                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mandibular                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/44 (2%)                3/47 (6%)                8/45 (18%)               2/45 (4%)       | 
|POLY-3 RATE (b)    |                  1/41.50                  3/45.24                  8/41.97                  2/44.00         | 
|POLY-3 PERCENT (g) |                  2.4%                     6.6%                     19.1%                    4.6%            | 
|TERMINAL (d)       |                  0/36 (0%)                3/40 (8%)                8/37 (22%)               2/39 (5%)       | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.409                  P=0.339                  P=0.020 *                P=0.519         | 
|POLY 3             |                  P=0.414                  P=0.337                  P=0.016 *                P=0.520         | 
|POLY 1.5           |                  P=0.408                  P=0.337                  P=0.016 *                P=0.518         | 
|POLY 6             |                  P=0.421                  P=0.337                  P=0.015 *                P=0.523         | 
|LOGISTIC REGRESSION|                  P=0.411                  P=0.333                  P=0.018 *                P=0.506         | 
|COCH-ARM / FISHERS |                  P=0.386                  P=0.334                  P=0.016 *                P=0.509         | 
|ORDER RESTRICTED   |                  P=0.087                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  5/44 (11%)               2/47 (4%)                3/45 (7%)                6/45 (13%)      | 
|POLY-3 RATE (b)    |                  5/41.51                  2/45.93                  3/41.97                  6/44.00         | 
|POLY-3 PERCENT (g) |                  12.1%                    4.4%                     7.2%                     13.6%           | 
|TERMINAL (d)       |                  3/36 (8%)                1/40 (3%)                3/37 (8%)                6/39 (15%)      | 
|FIRST INCIDENCE    |                  682                      498                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.309                  P=0.189N                 P=0.347N                 P=0.547         | 
|POLY 3             |                  P=0.291                  P=0.177N                 P=0.350N                 P=0.541         | 
|POLY 1.5           |                  P=0.290                  P=0.179N                 P=0.346N                 P=0.536         | 
|POLY 6             |                  P=0.291                  P=0.175N                 P=0.354N                 P=0.545         | 
|LOGISTIC REGRESSION|                  P=0.284                  P=0.211N                 P=0.347N                 P=0.548         | 
|COCH-ARM / FISHERS |                  P=0.286                  P=0.191N                 P=0.344N                 P=0.516         | 
|ORDER RESTRICTED   |                  P=0.278                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Mesenteric                                                                                                           | 
|     Infiltration Cellular Plasma Cell                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/44 (0%)                0/47 (0%)                2/45 (4%)                1/45 (2%)       | 
|POLY-3 RATE (b)    |                  0/41.31                  0/45.24                  2/41.97                  1/44.00         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.8%                     2.3%            | 
|TERMINAL (d)       |                  0/36 (0%)                0/40 (0%)                2/37 (5%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.247                  (e)                      P=0.244                  P=0.516         | 
|POLY 3             |                  P=0.250                  (e)                      P=0.241                  P=0.513         | 
|POLY 1.5           |                  P=0.247                  (e)                      P=0.242                  P=0.511         | 
|POLY 6             |                  P=0.254                  (e)                      P=0.240                  P=0.515         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.244                  P=0.516         | 
|COCH-ARM / FISHERS |                  P=0.237                  (e)                      P=0.253                  P=0.506         | 
|ORDER RESTRICTED   |                  P=0.171                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lymph Node: Renal                                                                                                                | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/44 (5%)                0/47 (0%)                0/45 (0%)                0/45 (0%)       | 
|POLY-3 RATE (b)    |                  2/41.51                  0/45.24                  0/41.97                  0/44.00         | 
|POLY-3 PERCENT (g) |                  4.8%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/36 (0%)                0/40 (0%)                0/37 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  682                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.124N                 P=0.227N                 P=0.239N                 P=0.237N        | 
|POLY 3             |                  P=0.123N                 P=0.218N                 P=0.234N                 P=0.224N        | 
|POLY 1.5           |                  P=0.122N                 P=0.218N                 P=0.233N                 P=0.226N        | 
|POLY 6             |                  P=0.123N                 P=0.218N                 P=0.236N                 P=0.223N        | 
|LOGISTIC REGRESSION|                  P=0.122N                 P=0.226N                 P=0.232N                 P=0.237N        | 
|COCH-ARM / FISHERS |                  P=0.121N                 P=0.231N                 P=0.242N                 P=0.242N        | 
|ORDER RESTRICTED   |                  P=0.025N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mesentery: Fat                                                                                                                   | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/1 (100%)               2/2 (100%)               1/1 (100%)               3/3 (100%)      | 
|POLY-3 RATE (b)    |                  1/1.00                   2/2.00                   1/1.00                   3/3.00          | 
|POLY-3 PERCENT (g) |                  100.0%                   100.0%                   100.0%                   100.0%          | 
|TERMINAL (d)       |                  1/1 (100%)               1/1 (100%)               1/1 (100%)               3/3 (100%)      | 
|FIRST INCIDENCE    |                  733 (T)                  708                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 3             |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 1.5           |                  (e)                      (e)                      (e)                      (e)             | 
|POLY 6             |                  (e)                      (e)                      (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  (e)                      (e)                      (e)                      (e)             | 
|ORDER RESTRICTED   |                  (e)                      (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/46 (2%)                1/48 (2%)                2/47 (4%)                0/44 (0%)       | 
|POLY-3 RATE (b)    |                  1/43.18                  1/46.24                  2/43.97                  0/43.49         | 
|POLY-3 PERCENT (g) |                  2.3%                     2.2%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                1/41 (2%)                2/39 (5%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.361N                 P=0.739N                 P=0.518                  P=0.489N        | 
|POLY 3             |                  P=0.368N                 P=0.745N                 P=0.506                  P=0.499N        | 
|POLY 1.5           |                  P=0.372N                 P=0.746N                 P=0.507                  P=0.501N        | 
|POLY 6             |                  P=0.362N                 P=0.744N                 P=0.506                  P=0.495N        | 
|LOGISTIC REGRESSION|                  P=0.361N                 P=0.739N                 P=0.518                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.382N                 P=0.742N                 P=0.508                  P=0.511N        | 
|ORDER RESTRICTED   |                  P=0.281N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  42/46 (91%)              45/48 (94%)              44/47 (94%)              41/44 (93%)     | 
|POLY-3 RATE (b)    |                  42/44.08                 45/47.52                 44/45.57                 41/43.94        | 
|POLY-3 PERCENT (g) |                  95.3%                    94.7%                    96.6%                    93.3%           | 
|TERMINAL (d)       |                  37/37 (100%)             39/41 (95%)              39/39 (100%)             37/39 (95%)     | 
|FIRST INCIDENCE    |                  639                      498                      498                      647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.239N                 P=0.460N                 P=0.616N                 P=0.261N        | 
|POLY 3             |                  P=0.443N                 P=0.646N                 P=0.600                  P=0.525N        | 
|POLY 1.5           |                  P=0.511N                 P=0.678N                 P=0.564                  P=0.593N        | 
|POLY 6             |                  P=0.363N                 P=0.610N                 P=0.660                  P=0.447N        | 
|LOGISTIC REGRESSION|                  P=0.450N                 P=0.628                  P=0.443                  P=0.427N        | 
|COCH-ARM / FISHERS |                  P=0.476                  P=0.476                  P=0.488                  P=0.525         | 
|ORDER RESTRICTED   |                  P=0.493N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  21/46 (46%)              19/48 (40%)              19/47 (40%)              13/44 (30%)     | 
|POLY-3 RATE (b)    |                  21/43.55                 19/47.19                 19/44.66                 13/43.55        | 
|POLY-3 PERCENT (g) |                  48.2%                    40.3%                    42.5%                    29.9%           | 
|TERMINAL (d)       |                  18/37 (49%)              16/41 (39%)              16/39 (41%)              12/39 (31%)     | 
|FIRST INCIDENCE    |                  682                      498                      620                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.049N*                P=0.275N                 P=0.349N                 P=0.048N*       | 
|POLY 3             |                  P=0.060N                 P=0.291N                 P=0.374N                 P=0.060N        | 
|POLY 1.5           |                  P=0.065N                 P=0.304N                 P=0.376N                 P=0.066N        | 
|POLY 6             |                  P=0.055N                 P=0.277N                 P=0.367N                 P=0.054N        | 
|LOGISTIC REGRESSION|                  P=0.062N                 P=0.320N                 P=0.387N                 P=0.049N*       | 
|COCH-ARM / FISHERS |                  P=0.079N                 P=0.350N                 P=0.382N                 P=0.087N        | 
|ORDER RESTRICTED   |                  P=0.061N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Hemorrhage                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/46 (9%)                2/48 (4%)                2/47 (4%)                2/44 (5%)       | 
|POLY-3 RATE (b)    |                  4/43.37                  2/46.24                  2/43.97                  2/43.49         | 
|POLY-3 PERCENT (g) |                  9.2%                     4.3%                     4.6%                     4.6%            | 
|TERMINAL (d)       |                  3/37 (8%)                2/41 (5%)                2/39 (5%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.290N                 P=0.296N                 P=0.320N                 P=0.318N        | 
|POLY 3             |                  P=0.311N                 P=0.308N                 P=0.331N                 P=0.336N        | 
|POLY 1.5           |                  P=0.314N                 P=0.309N                 P=0.329N                 P=0.342N        | 
|POLY 6             |                  P=0.306N                 P=0.307N                 P=0.333N                 P=0.329N        | 
|LOGISTIC REGRESSION|                  P=0.299N                 P=0.307N                 P=0.328N                 P=0.342N        | 
|COCH-ARM / FISHERS |                  P=0.319N                 P=0.318N                 P=0.328N                 P=0.360N        | 
|ORDER RESTRICTED   |                  P=0.275N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/46 (7%)                0/48 (0%)                0/47 (0%)                0/44 (0%)       | 
|POLY-3 RATE (b)    |                  3/43.35                  0/46.24                  0/43.97                  0/43.49         | 
|POLY-3 PERCENT (g) |                  6.9%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  688                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.051N                 P=0.106N                 P=0.116N                 P=0.114N        | 
|POLY 3             |                  P=0.053N                 P=0.107N                 P=0.116N                 P=0.118N        | 
|POLY 1.5           |                  P=0.053N                 P=0.108N                 P=0.115N                 P=0.120N        | 
|POLY 6             |                  P=0.053N                 P=0.107N                 P=0.116N                 P=0.115N        | 
|LOGISTIC REGRESSION|                  P=0.053N                 P=0.111N                 P=0.117N                 P=0.126N        | 
|COCH-ARM / FISHERS |                  P=0.054N                 P=0.113N                 P=0.117N                 P=0.129N        | 
|ORDER RESTRICTED   |                  P=0.008N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 22      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary: Bilateral                                                                                                                 | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/46 (15%)               3/48 (6%)                2/47 (4%)                3/44 (7%)       | 
|POLY-3 RATE (b)    |                  7/43.37                  3/46.24                  2/43.97                  3/43.49         | 
|POLY-3 PERCENT (g) |                  16.1%                    6.5%                     4.6%                     6.9%            | 
|TERMINAL (d)       |                  6/37 (16%)               3/41 (7%)                2/39 (5%)                3/39 (8%)       | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.126N                 P=0.123N                 P=0.072N                 P=0.141N        | 
|POLY 3             |                  P=0.142N                 P=0.132N                 P=0.075N                 P=0.155N        | 
|POLY 1.5           |                  P=0.144N                 P=0.133N                 P=0.074N                 P=0.161N        | 
|POLY 6             |                  P=0.139N                 P=0.131N                 P=0.075N                 P=0.150N        | 
|LOGISTIC REGRESSION|                  P=0.129N                 P=0.129N                 P=0.076N                 P=0.152N        | 
|COCH-ARM / FISHERS |                  P=0.149N                 P=0.141N                 P=0.074N                 P=0.176N        | 
|ORDER RESTRICTED   |                  P=0.061N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/45 (0%)                2/48 (4%)                0/47 (0%)                0/45 (0%)       | 
|POLY-3 RATE (b)    |                  0/42.31                  2/46.24                  0/43.97                  0/44.00         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  0/37 (0%)                2/41 (5%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      733 (T)                  ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.372N                 P=0.261                  (e)                      (e)             | 
|POLY 3             |                  P=0.370N                 P=0.257                  (e)                      (e)             | 
|POLY 1.5           |                  P=0.371N                 P=0.257                  (e)                      (e)             | 
|POLY 6             |                  P=0.368N                 P=0.258                  (e)                      (e)             | 
|LOGISTIC REGRESSION|                  (e)                      P=0.261                  (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.379N                 P=0.264                  (e)                      (e)             | 
|ORDER RESTRICTED   |                  P=0.257N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 23      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/45 (2%)                1/48 (2%)                1/47 (2%)                2/45 (4%)       | 
|POLY-3 RATE (b)    |                  1/42.31                  1/46.24                  1/43.97                  2/44.00         | 
|POLY-3 PERCENT (g) |                  2.4%                     2.2%                     2.3%                     4.6%            | 
|TERMINAL (d)       |                  1/37 (3%)                1/41 (2%)                1/39 (3%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.355                  P=0.739N                 P=0.750N                 P=0.518         | 
|POLY 3             |                  P=0.352                  P=0.741N                 P=0.752N                 P=0.514         | 
|POLY 1.5           |                  P=0.350                  P=0.741N                 P=0.751N                 P=0.511         | 
|POLY 6             |                  P=0.355                  P=0.740N                 P=0.753N                 P=0.517         | 
|LOGISTIC REGRESSION|                  P=0.355                  P=0.739N                 P=0.750N                 P=0.518         | 
|COCH-ARM / FISHERS |                  P=0.342                  P=0.736N                 P=0.742N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.420                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/45 (16%)               9/48 (19%)               4/47 (9%)                6/45 (13%)      | 
|POLY-3 RATE (b)    |                  7/42.50                  9/46.41                  4/43.97                  6/44.06         | 
|POLY-3 PERCENT (g) |                  16.5%                    19.4%                    9.1%                     13.6%           | 
|TERMINAL (d)       |                  6/37 (16%)               8/41 (20%)               4/39 (10%)               5/39 (13%)      | 
|FIRST INCIDENCE    |                  682                      690                      733 (T)                  718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.282N                 P=0.478                  P=0.236N                 P=0.459N        | 
|POLY 3             |                  P=0.292N                 P=0.468                  P=0.241N                 P=0.472N        | 
|POLY 1.5           |                  P=0.296N                 P=0.465                  P=0.238N                 P=0.478N        | 
|POLY 6             |                  P=0.289N                 P=0.470                  P=0.244N                 P=0.466N        | 
|LOGISTIC REGRESSION|                  P=0.282N                 P=0.469                  P=0.239N                 P=0.467N        | 
|COCH-ARM / FISHERS |                  P=0.308N                 P=0.448                  P=0.236N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.309N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 24      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/45 (2%)                2/48 (4%)                1/47 (2%)                2/45 (4%)       | 
|POLY-3 RATE (b)    |                  1/42.31                  2/46.56                  1/43.97                  2/44.37         | 
|POLY-3 PERCENT (g) |                  2.4%                     4.3%                     2.3%                     4.5%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                1/39 (3%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  675                      733 (T)                  647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.462                  P=0.536                  P=0.750N                 P=0.523         | 
|POLY 3             |                  P=0.459                  P=0.533                  P=0.752N                 P=0.517         | 
|POLY 1.5           |                  P=0.455                  P=0.531                  P=0.751N                 P=0.512         | 
|POLY 6             |                  P=0.465                  P=0.537                  P=0.753N                 P=0.522         | 
|LOGISTIC REGRESSION|                  P=0.428                  P=0.513                  P=0.750N                 P=0.477         | 
|COCH-ARM / FISHERS |                  P=0.443                  P=0.524                  P=0.742N                 P=0.500         | 
|ORDER RESTRICTED   |                  P=0.465                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis                                                                                                   | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/41 (7%)                1/45 (2%)                3/44 (7%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  3/38.35                  1/43.24                  3/41.14                  2/43.65         | 
|POLY-3 PERCENT (g) |                  7.8%                     2.3%                     7.3%                     4.6%            | 
|TERMINAL (d)       |                  2/32 (6%)                1/38 (3%)                3/37 (8%)                2/38 (5%)       | 
|FIRST INCIDENCE    |                  688                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.484N                 P=0.254N                 P=0.604N                 P=0.434N        | 
|POLY 3             |                  P=0.495N                 P=0.263N                 P=0.630N                 P=0.441N        | 
|POLY 1.5           |                  P=0.494N                 P=0.264N                 P=0.629N                 P=0.441N        | 
|POLY 6             |                  P=0.496N                 P=0.261N                 P=0.630N                 P=0.440N        | 
|LOGISTIC REGRESSION|                  P=0.488N                 P=0.264N                 P=0.628N                 P=0.439N        | 
|COCH-ARM / FISHERS |                  P=0.494N                 P=0.274N                 P=0.628N                 P=0.445N        | 
|ORDER RESTRICTED   |                  P=0.415N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 25      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Acinus, Parotid Gland                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                3/48 (6%)                0/47 (0%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  1/43.40                  3/46.56                  0/43.97                  1/44.71         | 
|POLY-3 PERCENT (g) |                  2.3%                     6.4%                     0.0%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                1/41 (2%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  682                      675                      ---                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.380N                 P=0.341                  P=0.505N                 P=0.747N        | 
|POLY 3             |                  P=0.381N                 P=0.331                  P=0.497N                 P=0.754N        | 
|POLY 1.5           |                  P=0.382N                 P=0.328                  P=0.497N                 P=0.754N        | 
|POLY 6             |                  P=0.381N                 P=0.334                  P=0.498N                 P=0.754N        | 
|LOGISTIC REGRESSION|                  P=0.395N                 P=0.297                  P=0.505N                 P=0.761         | 
|COCH-ARM / FISHERS |                  P=0.390N                 P=0.316                  P=0.500N                 P=0.753N        | 
|ORDER RESTRICTED   |                  P=0.277N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Acinus, Parotid Gland                                                                                           | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/48 (0%)                3/47 (6%)                2/47 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  0/46.24                  3/43.97                  2/44.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     6.8%                     4.5%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                3/39 (8%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.093                  (e)                      P=0.130                  P=0.250         | 
|POLY 3             |                  P=0.092                  (e)                      P=0.122                  P=0.245         | 
|POLY 1.5           |                  P=0.093                  (e)                      P=0.122                  P=0.244         | 
|POLY 6             |                  P=0.092                  (e)                      P=0.122                  P=0.245         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.130                  P=0.250         | 
|COCH-ARM / FISHERS |                  P=0.090                  (e)                      P=0.121                  P=0.247         | 
|ORDER RESTRICTED   |                  P=0.083                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 26      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Parotid Gland                                                                                                   | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  9/47 (19%)               9/48 (19%)               8/47 (17%)               11/47 (23%)     | 
|POLY-3 RATE (b)    |                  9/43.40                  9/46.94                  8/43.97                  11/45.20        | 
|POLY-3 PERCENT (g) |                  20.7%                    19.2%                    18.2%                    24.3%           | 
|TERMINAL (d)       |                  8/37 (22%)               7/41 (17%)               8/39 (21%)               9/39 (23%)      | 
|FIRST INCIDENCE    |                  682                      590                      733 (T)                  584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.362                  P=0.514N                 P=0.456N                 P=0.453         | 
|POLY 3             |                  P=0.353                  P=0.531N                 P=0.488N                 P=0.441         | 
|POLY 1.5           |                  P=0.353                  P=0.541N                 P=0.487N                 P=0.435         | 
|POLY 6             |                  P=0.354                  P=0.519N                 P=0.491N                 P=0.447         | 
|LOGISTIC REGRESSION|                  P=0.350                  P=0.559N                 P=0.481N                 P=0.428         | 
|COCH-ARM / FISHERS |                  P=0.336                  P=0.584N                 P=0.500N                 P=0.401         | 
|ORDER RESTRICTED   |                  P=0.449                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Parotid Gland                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/47 (4%)                0/48 (0%)                1/47 (2%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  2/43.21                  0/46.24                  1/44.05                  0/44.65         | 
|POLY-3 PERCENT (g) |                  4.6%                     0.0%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  2/37 (5%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  ---                      714                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.192N                 P=0.216N                 P=0.482N                 P=0.227N        | 
|POLY 3             |                  P=0.203N                 P=0.222N                 P=0.493N                 P=0.230N        | 
|POLY 1.5           |                  P=0.202N                 P=0.224N                 P=0.494N                 P=0.230N        | 
|POLY 6             |                  P=0.204N                 P=0.221N                 P=0.493N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.196N                 (e)                      P=0.494N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.200N                 P=0.242N                 P=0.500N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.069N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 27      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Sublingual Gland                                                                                                | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/48 (0%)                2/47 (4%)                1/47 (2%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  0/46.24                  2/43.97                  1/44.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                2/39 (5%)                1/39 (3%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.241                  (e)                      P=0.250                  P=0.511         | 
|POLY 3             |                  P=0.242                  (e)                      P=0.241                  P=0.507         | 
|POLY 1.5           |                  P=0.242                  (e)                      P=0.241                  P=0.506         | 
|POLY 6             |                  P=0.242                  (e)                      P=0.241                  P=0.507         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.250                  P=0.511         | 
|COCH-ARM / FISHERS |                  P=0.236                  (e)                      P=0.247                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.171                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands: Submandibular Gland                                                                                             | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  33/47 (70%)              30/48 (63%)              35/47 (74%)              31/47 (66%)     | 
|POLY-3 RATE (b)    |                  33/43.72                 30/47.79                 35/45.72                 31/45.52        | 
|POLY-3 PERCENT (g) |                  75.5%                    62.8%                    76.6%                    68.1%           | 
|TERMINAL (d)       |                  30/37 (81%)              26/41 (63%)              30/39 (77%)              28/39 (72%)     | 
|FIRST INCIDENCE    |                  682                      498                      498                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.424N                 P=0.142N                 P=0.558                  P=0.275N        | 
|POLY 3             |                  P=0.449N                 P=0.137N                 P=0.552                  P=0.294N        | 
|POLY 1.5           |                  P=0.449N                 P=0.165N                 P=0.513                  P=0.311N        | 
|POLY 6             |                  P=0.447N                 P=0.113N                 P=0.593                  P=0.276N        | 
|LOGISTIC REGRESSION|                  P=0.452N                 P=0.192N                 P=0.459                  P=0.326N        | 
|COCH-ARM / FISHERS |                  P=0.502N                 P=0.282N                 P=0.409                  P=0.413N        | 
|ORDER RESTRICTED   |                  P=0.356N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 28      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skeletal Muscle                                                                                                                  | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                0/48 (0%)                0/47 (0%)                2/46 (4%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  0/46.24                  0/43.97                  2/44.52         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     4.5%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                0/39 (0%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      444             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.050                  (e)                      (e)                      P=0.258         | 
|POLY 3             |                  P=0.043 *                (e)                      (e)                      P=0.244         | 
|POLY 1.5           |                  P=0.043 *                (e)                      (e)                      P=0.242         | 
|POLY 6             |                  P=0.043 *                (e)                      (e)                      P=0.246         | 
|LOGISTIC REGRESSION|                  P=0.021 *                (e)                      (e)                      P=0.136         | 
|COCH-ARM / FISHERS |                  P=0.043 *                (e)                      (e)                      P=0.242         | 
|ORDER RESTRICTED   |                  P=0.031 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spinal Cord: Thoracic, Axon                                                                                                      | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  12/47 (26%)              11/48 (23%)              9/47 (19%)               14/47 (30%)     | 
|POLY-3 RATE (b)    |                  12/43.40                 11/46.34                 9/43.97                  14/44.69        | 
|POLY-3 PERCENT (g) |                  27.7%                    23.7%                    20.5%                    31.3%           | 
|TERMINAL (d)       |                  11/37 (30%)              10/41 (24%)              9/39 (23%)               13/39 (33%)     | 
|FIRST INCIDENCE    |                  682                      708                      733 (T)                  723             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.365                  P=0.390N                 P=0.264N                 P=0.469         | 
|POLY 3             |                  P=0.345                  P=0.428N                 P=0.297N                 P=0.443         | 
|POLY 1.5           |                  P=0.348                  P=0.435N                 P=0.296N                 P=0.442         | 
|POLY 6             |                  P=0.342                  P=0.423N                 P=0.299N                 P=0.443         | 
|LOGISTIC REGRESSION|                  P=0.366                  P=0.411N                 P=0.287N                 P=0.465         | 
|COCH-ARM / FISHERS |                  P=0.335                  P=0.477N                 P=0.311N                 P=0.409         | 
|ORDER RESTRICTED   |                  P=0.342                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 29      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  11/45 (24%)              9/48 (19%)               17/47 (36%)              17/45 (38%)     | 
|POLY-3 RATE (b)    |                  11/42.84                 9/47.22                  17/46.42                 17/44.90        | 
|POLY-3 PERCENT (g) |                  25.7%                    19.1%                    36.6%                    37.9%           | 
|TERMINAL (d)       |                  6/37 (16%)               4/41 (10%)               12/39 (31%)              13/39 (33%)     | 
|FIRST INCIDENCE    |                  639                      590                      193                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.063                  P=0.327N                 P=0.182                  P=0.186         | 
|POLY 3             |                  P=0.044 *                P=0.310N                 P=0.189                  P=0.161         | 
|POLY 1.5           |                  P=0.043 *                P=0.310N                 P=0.188                  P=0.156         | 
|POLY 6             |                  P=0.045 *                P=0.311N                 P=0.184                  P=0.162         | 
|LOGISTIC REGRESSION|                  P=0.024 *                P=0.349N                 P=0.150                  P=0.128         | 
|COCH-ARM / FISHERS |                  P=0.035 *                P=0.339N                 P=0.160                  P=0.127         | 
|ORDER RESTRICTED   |                  P=0.086                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  14/45 (31%)              4/48 (8%)                8/47 (17%)               9/45 (20%)      | 
|POLY-3 RATE (b)    |                  14/42.38                 4/46.24                  8/43.97                  9/44.00         | 
|POLY-3 PERCENT (g) |                  33.0%                    8.7%                     18.2%                    20.5%           | 
|TERMINAL (d)       |                  11/37 (30%)              4/41 (10%)               8/39 (21%)               9/39 (23%)      | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.303N                 P=0.006N**               P=0.094N                 P=0.142N        | 
|POLY 3             |                  P=0.317N                 P=0.004N**               P=0.089N                 P=0.140N        | 
|POLY 1.5           |                  P=0.320N                 P=0.004N**               P=0.086N                 P=0.142N        | 
|POLY 6             |                  P=0.316N                 P=0.004N**               P=0.096N                 P=0.141N        | 
|LOGISTIC REGRESSION|                  P=0.295N                 P=0.005N**               P=0.090N                 P=0.134N        | 
|COCH-ARM / FISHERS |                  P=0.334N                 P=0.005N**               P=0.090N                 P=0.167N        | 
|ORDER RESTRICTED   |                  P=0.029N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 30      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Forestomach                                                                                                             | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/45 (0%)                0/48 (0%)                2/47 (4%)                0/46 (0%)       | 
|POLY-3 RATE (b)    |                  0/42.19                  0/46.24                  2/43.97                  0/44.43         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                2/39 (5%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.589                  (e)                      P=0.250                  (e)             | 
|POLY 3             |                  P=0.599                  (e)                      P=0.246                  (e)             | 
|POLY 1.5           |                  P=0.598                  (e)                      P=0.248                  (e)             | 
|POLY 6             |                  P=0.598                  (e)                      P=0.244                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.250                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.585                  (e)                      P=0.258                  (e)             | 
|ORDER RESTRICTED   |                  P=0.255                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Forestomach, Epithelium                                                                                                 | 
|     Hyperplasia Focal                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/45 (7%)                4/48 (8%)                8/47 (17%)               6/46 (13%)      | 
|POLY-3 RATE (b)    |                  3/42.19                  4/46.24                  8/44.35                  6/44.43         | 
|POLY-3 PERCENT (g) |                  7.1%                     8.7%                     18.0%                    13.5%           | 
|TERMINAL (d)       |                  3/37 (8%)                4/41 (10%)               7/39 (18%)               6/39 (15%)      | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  627                      733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.168                  P=0.556                  P=0.117                  P=0.267         | 
|POLY 3             |                  P=0.172                  P=0.550                  P=0.114                  P=0.268         | 
|POLY 1.5           |                  P=0.172                  P=0.551                  P=0.116                  P=0.268         | 
|POLY 6             |                  P=0.170                  P=0.548                  P=0.112                  P=0.266         | 
|LOGISTIC REGRESSION|                  P=0.169                  P=0.556                  P=0.113                  P=0.267         | 
|COCH-ARM / FISHERS |                  P=0.161                  P=0.536                  P=0.113                  P=0.254         | 
|ORDER RESTRICTED   |                  P=0.169                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 31      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Stomach: Glandular                                                                                                               | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/45 (2%)                2/48 (4%)                1/47 (2%)                0/46 (0%)       | 
|POLY-3 RATE (b)    |                  1/42.19                  2/46.24                  1/43.97                  0/44.43         | 
|POLY-3 PERCENT (g) |                  2.4%                     4.3%                     2.3%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                2/41 (5%)                1/39 (3%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.232N                 P=0.536                  P=0.750N                 P=0.489N        | 
|POLY 3             |                  P=0.231N                 P=0.532                  P=0.751N                 P=0.490N        | 
|POLY 1.5           |                  P=0.230N                 P=0.532                  P=0.750N                 P=0.490N        | 
|POLY 6             |                  P=0.231N                 P=0.531                  P=0.754N                 P=0.490N        | 
|LOGISTIC REGRESSION|                  P=0.232N                 P=0.536                  P=0.750N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.235N                 P=0.524                  P=0.742N                 P=0.495N        | 
|ORDER RESTRICTED   |                  P=0.235N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/43 (5%)                2/45 (4%)                1/45 (2%)                0/43 (0%)       | 
|POLY-3 RATE (b)    |                  2/40.97                  2/43.52                  1/42.53                  0/41.32         | 
|POLY-3 PERCENT (g) |                  4.9%                     4.6%                     2.4%                     0.0%            | 
|TERMINAL (d)       |                  1/35 (3%)                0/39 (0%)                0/38 (0%)                0/38 (0%)       | 
|FIRST INCIDENCE    |                  695                      690                      620                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.121N                 P=0.654N                 P=0.485N                 P=0.223N        | 
|POLY 3             |                  P=0.123N                 P=0.672N                 P=0.487N                 P=0.235N        | 
|POLY 1.5           |                  P=0.122N                 P=0.672N                 P=0.486N                 P=0.235N        | 
|POLY 6             |                  P=0.123N                 P=0.671N                 P=0.487N                 P=0.235N        | 
|LOGISTIC REGRESSION|                  P=0.125N                 P=0.684N                 P=0.483N                 P=0.237N        | 
|COCH-ARM / FISHERS |                  P=0.122N                 P=0.674N                 P=0.483N                 P=0.247N        | 
|ORDER RESTRICTED   |                  P=0.153N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 32      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/43 (5%)                1/45 (2%)                2/45 (4%)                2/43 (5%)       | 
|POLY-3 RATE (b)    |                  2/40.97                  1/43.34                  2/42.14                  2/41.32         | 
|POLY-3 PERCENT (g) |                  4.9%                     2.3%                     4.8%                     4.8%            | 
|TERMINAL (d)       |                  1/35 (3%)                1/39 (3%)                2/38 (5%)                2/38 (5%)       | 
|FIRST INCIDENCE    |                  695                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.538                  P=0.464N                 P=0.669N                 P=0.665N        | 
|POLY 3             |                  P=0.514                  P=0.480N                 P=0.684N                 P=0.691N        | 
|POLY 1.5           |                  P=0.514                  P=0.480N                 P=0.681N                 P=0.690N        | 
|POLY 6             |                  P=0.515                  P=0.481N                 P=0.686N                 P=0.690N        | 
|LOGISTIC REGRESSION|                  P=0.516                  P=0.482N                 P=0.683N                 P=0.692N        | 
|COCH-ARM / FISHERS |                  P=0.513                  P=0.483N                 P=0.674N                 P=0.692N        | 
|ORDER RESTRICTED   |                  P=0.604                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Ectopic Parathyroid Gland                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/43 (9%)                7/45 (16%)               4/45 (9%)                7/43 (16%)      | 
|POLY-3 RATE (b)    |                  4/40.82                  7/43.34                  4/42.14                  7/41.63         | 
|POLY-3 PERCENT (g) |                  9.8%                     16.2%                    9.5%                     16.8%           | 
|TERMINAL (d)       |                  4/35 (11%)               7/39 (18%)               4/38 (11%)               6/38 (16%)      | 
|FIRST INCIDENCE    |                  733 (T)                  733 (T)                  733 (T)                  647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.337                  P=0.324                  P=0.599N                 P=0.307         | 
|POLY 3             |                  P=0.305                  P=0.295                  P=0.626N                 P=0.271         | 
|POLY 1.5           |                  P=0.304                  P=0.296                  P=0.622N                 P=0.270         | 
|POLY 6             |                  P=0.311                  P=0.297                  P=0.628N                 P=0.277         | 
|LOGISTIC REGRESSION|                  P=0.302                  P=0.324                  P=0.599N                 P=0.265         | 
|COCH-ARM / FISHERS |                  P=0.296                  P=0.288                  P=0.617N                 P=0.260         | 
|ORDER RESTRICTED   |                  P=0.279                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 33      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Hyperplasia Lymphoid                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/43 (5%)                3/45 (7%)                5/45 (11%)               6/43 (14%)      | 
|POLY-3 RATE (b)    |                  2/41.02                  3/43.34                  5/42.14                  6/41.32         | 
|POLY-3 PERCENT (g) |                  4.9%                     6.9%                     11.9%                    14.5%           | 
|TERMINAL (d)       |                  0/35 (0%)                3/39 (8%)                5/38 (13%)               6/38 (16%)      | 
|FIRST INCIDENCE    |                  682                      733 (T)                  733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.088                  P=0.540                  P=0.244                  P=0.160         | 
|POLY 3             |                  P=0.073                  P=0.525                  P=0.226                  P=0.134         | 
|POLY 1.5           |                  P=0.074                  P=0.526                  P=0.230                  P=0.135         | 
|POLY 6             |                  P=0.073                  P=0.524                  P=0.223                  P=0.134         | 
|LOGISTIC REGRESSION|                  P=0.076                  P=0.526                  P=0.228                  P=0.136         | 
|COCH-ARM / FISHERS |                  P=0.073                  P=0.522                  P=0.236                  P=0.133         | 
|ORDER RESTRICTED   |                  P=0.106                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Ultimobranchial Cyst                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                2/48 (4%)                2/47 (4%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  0/42.21                  2/46.24                  2/43.97                  0/44.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     4.3%                     4.6%                     0.0%            | 
|TERMINAL (d)       |                  0/36 (0%)                2/41 (5%)                2/39 (5%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      733 (T)                  733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.473N                 P=0.267                  P=0.256                  (e)             | 
|POLY 3             |                  P=0.467N                 P=0.258                  P=0.246                  (e)             | 
|POLY 1.5           |                  P=0.469N                 P=0.256                  P=0.246                  (e)             | 
|POLY 6             |                  P=0.465N                 P=0.260                  P=0.246                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      P=0.267                  P=0.256                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.483N                 P=0.258                  P=0.253                  (e)             | 
|ORDER RESTRICTED   |                  P=0.277N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 34      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/46 (15%)               10/48 (21%)              6/47 (13%)               9/47 (19%)      | 
|POLY-3 RATE (b)    |                  7/42.55                  10/46.50                 6/43.97                  9/44.75         | 
|POLY-3 PERCENT (g) |                  16.5%                    21.5%                    13.6%                    20.1%           | 
|TERMINAL (d)       |                  5/36 (14%)               8/41 (20%)               6/39 (15%)               7/39 (18%)      | 
|FIRST INCIDENCE    |                  682                      690                      733 (T)                  718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.497                  P=0.401                  P=0.448N                 P=0.458         | 
|POLY 3             |                  P=0.481                  P=0.369                  P=0.475N                 P=0.435         | 
|POLY 1.5           |                  P=0.484                  P=0.364                  P=0.473N                 P=0.435         | 
|POLY 6             |                  P=0.478                  P=0.374                  P=0.479N                 P=0.434         | 
|LOGISTIC REGRESSION|                  P=0.485                  P=0.365                  P=0.468N                 P=0.440         | 
|COCH-ARM / FISHERS |                  P=0.467                  P=0.331                  P=0.483N                 P=0.411         | 
|ORDER RESTRICTED   |                  P=0.520                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tongue                                                                                                                           | 
|     Foreign Body                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/47 (0%)                3/48 (6%)                1/47 (2%)                3/47 (6%)       | 
|POLY-3 RATE (b)    |                  0/43.21                  3/46.72                  1/43.97                  3/44.65         | 
|POLY-3 PERCENT (g) |                  0.0%                     6.4%                     2.3%                     6.7%            | 
|TERMINAL (d)       |                  0/37 (0%)                2/41 (5%)                1/39 (3%)                3/39 (8%)       | 
|FIRST INCIDENCE    |                  ---                      590                      733 (T)                  733 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.179                  P=0.140                  P=0.511                  P=0.130         | 
|POLY 3             |                  P=0.182                  P=0.133                  P=0.504                  P=0.125         | 
|POLY 1.5           |                  P=0.182                  P=0.131                  P=0.503                  P=0.124         | 
|POLY 6             |                  P=0.183                  P=0.136                  P=0.504                  P=0.125         | 
|LOGISTIC REGRESSION|                  P=0.173                  P=0.104                  P=0.511                  P=0.130         | 
|COCH-ARM / FISHERS |                  P=0.173                  P=0.125                  P=0.500                  P=0.121         | 
|ORDER RESTRICTED   |                  P=0.081                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 35      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Tongue: Artery                                                                                                                   | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/47 (2%)                2/48 (4%)                2/47 (4%)                0/47 (0%)       | 
|POLY-3 RATE (b)    |                  1/43.21                  2/46.26                  2/44.37                  0/44.65         | 
|POLY-3 PERCENT (g) |                  2.3%                     4.3%                     4.5%                     0.0%            | 
|TERMINAL (d)       |                  1/37 (3%)                1/41 (2%)                1/39 (3%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  733 (T)                  729                      620                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.287N                 P=0.535                  P=0.515                  P=0.489N        | 
|POLY 3             |                  P=0.282N                 P=0.524                  P=0.509                  P=0.493N        | 
|POLY 1.5           |                  P=0.283N                 P=0.521                  P=0.508                  P=0.494N        | 
|POLY 6             |                  P=0.281N                 P=0.526                  P=0.511                  P=0.493N        | 
|LOGISTIC REGRESSION|                  P=0.292N                 P=0.533                  P=0.497                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.291N                 P=0.508                  P=0.500                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.234N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Inclusion Body Intracytoplasmic                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  14/46 (30%)              33/48 (69%)              44/47 (94%)              44/44 (100%)    | 
|POLY-3 RATE (b)    |                  14/44.52                 33/46.93                 44/45.67                 44/44.00        | 
|POLY-3 PERCENT (g) |                  31.5%                    70.3%                    96.3%                    100.0%          | 
|TERMINAL (d)       |                  10/37 (27%)              32/41 (78%)              39/39 (100%)             39/39 (100%)    | 
|FIRST INCIDENCE    |                  122                      498                      498                      584             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 3             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 1.5           |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|POLY 6             |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|LOGISTIC REGRESSION|                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|COCH-ARM / FISHERS |                  P<0.001 **               P<0.001 **               P<0.001 **               P<0.001 **      | 
|ORDER RESTRICTED   |                  P<0.001 **               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 36      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Urinary Bladder                                                                                                                  | 
|     Infiltration Cellular Lymphocytic                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  29/46 (63%)              22/48 (46%)              24/47 (51%)              26/44 (59%)     | 
|POLY-3 RATE (b)    |                  29/44.19                 22/46.82                 24/44.10                 26/43.19        | 
|POLY-3 PERCENT (g) |                  65.6%                    47.0%                    54.4%                    60.2%           | 
|TERMINAL (d)       |                  26/37 (70%)              20/41 (49%)              23/39 (59%)              23/39 (59%)     | 
|FIRST INCIDENCE    |                  518                      590                      700                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.400N                 P=0.041N*                P=0.127N                 P=0.239N        | 
|POLY 3             |                  P=0.531                  P=0.054N                 P=0.193N                 P=0.380N        | 
|POLY 1.5           |                  P=0.529                  P=0.056N                 P=0.180N                 P=0.386N        | 
|POLY 6             |                  P=0.535                  P=0.052N                 P=0.206N                 P=0.371N        | 
|LOGISTIC REGRESSION|                  P=0.499N                 P=0.056N                 P=0.168N                 P=0.346N        | 
|COCH-ARM / FISHERS |                  P=0.506                  P=0.071N                 P=0.169N                 P=0.433N        | 
|ORDER RESTRICTED   |                  P=0.204N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Angiectasis                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                4/48 (8%)                3/47 (6%)                1/46 (2%)       | 
|POLY-3 RATE (b)    |                  0/43.18                  4/46.72                  3/43.97                  1/44.74         | 
|POLY-3 PERCENT (g) |                  0.0%                     8.6%                     6.8%                     2.2%            | 
|TERMINAL (d)       |                  0/37 (0%)                3/41 (7%)                3/39 (8%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      590                      733 (T)                  647             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.570N                 P=0.078                  P=0.130                  P=0.505         | 
|POLY 3             |                  P=0.561N                 P=0.071                  P=0.122                  P=0.507         | 
|POLY 1.5           |                  P=0.566N                 P=0.070                  P=0.122                  P=0.506         | 
|POLY 6             |                  P=0.554N                 P=0.072                  P=0.121                  P=0.509         | 
|LOGISTIC REGRESSION|                  P=0.592N                 P=0.059                  P=0.130                  P=0.454         | 
|COCH-ARM / FISHERS |                  P=0.581N                 P=0.064                  P=0.125                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.142                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 37      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  42/46 (91%)              46/48 (96%)              47/47 (100%)             43/46 (93%)     | 
|POLY-3 RATE (b)    |                  42/44.88                 46/47.52                 47/47.00                 43/45.45        | 
|POLY-3 PERCENT (g) |                  93.6%                    96.8%                    100.0%                   94.6%           | 
|TERMINAL (d)       |                  35/37 (95%)              40/41 (98%)              39/39 (100%)             38/39 (97%)     | 
|FIRST INCIDENCE    |                  518                      498                      193                      553             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.465N                 P=0.562N                 P=0.320                  P=0.482N        | 
|POLY 3             |                  P=0.542                  P=0.404                  P=0.116                  P=0.597         | 
|POLY 1.5           |                  P=0.556                  P=0.420                  P=0.106                  P=0.611         | 
|POLY 6             |                  P=0.510                  P=0.376                  P=0.123                  P=0.569         | 
|LOGISTIC REGRESSION|                  P=0.536                  P=0.456                  P=0.055                  P=0.661         | 
|COCH-ARM / FISHERS |                  P=0.440                  P=0.318                  P=0.056                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.258                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Thrombosis                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/46 (0%)                1/48 (2%)                3/47 (6%)                0/46 (0%)       | 
|POLY-3 RATE (b)    |                  0/43.18                  1/46.72                  3/43.97                  0/44.43         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.1%                     6.8%                     0.0%            | 
|TERMINAL (d)       |                  0/37 (0%)                0/41 (0%)                3/39 (8%)                0/39 (0%)       | 
|FIRST INCIDENCE    |                  ---                      590                      733 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.630N                 P=0.513                  P=0.130                  (e)             | 
|POLY 3             |                  P=0.627N                 P=0.516                  P=0.122                  (e)             | 
|POLY 1.5           |                  P=0.629N                 P=0.514                  P=0.122                  (e)             | 
|POLY 6             |                  P=0.625N                 P=0.518                  P=0.121                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.619                  P=0.423                  P=0.130                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.629                  P=0.511                  P=0.125                  (e)             | 
|ORDER RESTRICTED   |                  P=0.224                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/19/03                           EXPERIMENT: 93029 TEST: 04                                            Page 38      
Statistical Analysis of Non-neoplastic Lesions in       Mice(C57BL/6NXC3H/HEN MTN-NCTR)  -                   LEUKOMALACHITE GREEN   
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 PPM                    91 PPM                   204 PPM                  408 PPM         | 
|                   |                                                                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina: Epithelium                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/45 (2%)                0/47 (0%)                0/47 (0%)                3/46 (7%)       | 
|POLY-3 RATE (b)    |                  1/42.31                  0/45.41                  0/43.97                  3/44.49         | 
|POLY-3 PERCENT (g) |                  2.4%                     0.0%                     0.0%                     6.7%            | 
|TERMINAL (d)       |                  1/37 (3%)                0/41 (0%)                0/39 (0%)                2/39 (5%)       | 
|FIRST INCIDENCE    |                  733 (T)                  ---                      ---                      718             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.087                  P=0.480N                 P=0.489N                 P=0.332         | 
|POLY 3             |                  P=0.081                  P=0.486N                 P=0.492N                 P=0.323         | 
|POLY 1.5           |                  P=0.081                  P=0.487N                 P=0.492N                 P=0.322         | 
|POLY 6             |                  P=0.080                  P=0.485N                 P=0.493N                 P=0.326         | 
|LOGISTIC REGRESSION|                  P=0.085                  (e)                      (e)                      P=0.324         | 
|COCH-ARM / FISHERS |                  P=0.082                  P=0.489N                 P=0.489N                 P=0.317         | 
|ORDER RESTRICTED   |                  P=0.043 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.