National Toxicology Program

National Toxicology Program
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TDMS Study 61529-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                      M-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 61529 TEST: 01                                                                                     TIME: 08:47:58       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: 61529B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 108-42-09       
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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: Battelle Columbus                                      M-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 61529 TEST: 01                                                                                     TIME: 08:47:58       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: 61529B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 108-42-09       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                    M-CHLOROANILINE                                                                               
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Bone Marrow                            Pigmentation Hemosiderin                                                                     
Bone Marrow: Erythroid Cell            Hyperplasia                                                                                  
Heart                                  Cardiomyopathy                                                                               
Kidney: Cortex                         Pigmentation Hemosiderin                                                                     
Kidney: Renal Tubule                   Regeneration Focal                                                                           
Liver                                  Hematopoietic Cell Proliferation                                                             
Liver: Kupffer Cell                    Pigmentation                                                                                 
Preputial Gland                        Inflammation Chronic Focal                                                                   
Spleen                                 Congestion                                                                                   
                                       Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
Spleen: Capsule                        Fibrosis                                                                                     
                                       Infiltration Cellular                                                                        
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone Marrow                            Myelofibrosis                                                                                
                                       Pigmentation Hemosiderin                                                                     
Bone Marrow: Erythroid Cell            Hyperplasia                                                                                  
Kidney: Cortex                         Pigmentation Hemosiderin                                                                     
Kidney: Renal Tubule                   Regeneration Focal                                                                           
Liver                                  Hematopoietic Cell Proliferation                                                             
                                       Pigmentation                                                                                 
Liver: Kupffer Cell                    Pigmentation                                                                                 
Spleen                                 Congestion                                                                                   
                                       Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
Spleen: Capsule                        Fibrosis                                                                                     
                                       Infiltration Cellular                                                                        
===============================================================                                                                     
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                     M-CHLOROANILINE                   
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       2/10 (20%)       3/10 (30%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          1/10.00          2/10.00          3/10.00          0/10.00          0/9.59          | 
|POLY-3 PERCENT (g) |        0.0%             10.0%            20.0%            30.0%            0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       2/10 (20%)       3/10 (30%)       0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.239N         P=0.500          P=0.234          P=0.111          (e)              (e)             | 
|POLY 3             |        P=0.220N         P=0.500          P=0.227          P=0.095          (e)              (e)             | 
|POLY 1.5           |        P=0.216N         P=0.500          P=0.227          P=0.095          (e)              (e)             | 
|POLY 6             |        P=0.225N         P=0.500          P=0.227          P=0.095          (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.500          P=0.234          P=0.111          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.217N         P=0.500          P=0.237          P=0.105          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.228N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Myelofibrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Myelofibrosis                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       1/10 (10%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        3/10.00          1/10.00          0/10.00          0/10.00          1/10.00          1/9.59          | 
|POLY-3 PERCENT (g) |        30.0%            10.0%            0.0%             0.0%             10.0%            10.4%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        3/10 (30%)       1/10 (10%)       0/10 (0%)        0/10 (0%)        1/10 (10%)       1/9 (11%)       | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           ---              ---              93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.471N         P=0.293N         P=0.111N         P=0.111N         P=0.293N         P=0.333N        | 
|POLY 3             |        P=0.442N         P=0.292N         P=0.095N         P=0.095N         P=0.292N         P=0.308N        | 
|POLY 1.5           |        P=0.440N         P=0.292N         P=0.095N         P=0.095N         P=0.292N         P=0.301N        | 
|POLY 6             |        P=0.445N         P=0.292N         P=0.095N         P=0.095N         P=0.292N         P=0.318N        | 
|LOGISTIC REGRESSION|        P=0.471N         P=0.293N         (e)              (e)              P=0.293N         P=0.333N        | 
|COCH-ARM / FISHERS |        P=0.438N         P=0.291N         P=0.105N         P=0.105N         P=0.291N         P=0.291N        | 
|ORDER RESTRICTED   |        P=0.049N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       (e)              (e)              (e)              P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow                                                                                                                      | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        3/10 (30%)       10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          3/10.00          10/10.00         9/9.59          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             30.0%            100.0%           93.9%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        3/10 (30%)       10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.111          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.095          P<0.001N**       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.095          P<0.001N**       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.095          P<0.001N**       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.111          P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.105          P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow: Erythroid Cell                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Bone Marrow: Erythroid Cell                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          6/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             60.0%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.009 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.009 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.005 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|INT SACRIFICE 1 (c)|                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Clitoral Gland                                                                                                                   | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         7/10 (70%)      | 
|POLY-3 RATE (b)    |        5/10.00          0/0.00           0/0.00           0/0.00           0/0.00           7/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             0.0%             70.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         6/9 (67%)       | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.146          P=1.000          P=1.000          P=1.000N         P=1.000N         P=0.257         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|LOGISTIC REGRESSION|        P=0.146          (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.247          P=1.000          P=1.000          P=1.000          P=1.000          P=0.325         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        10/10.00         0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             0.0%             50.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.012N*        (e)              (e)              (e)              (e)              P=0.022N*       | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|LOGISTIC REGRESSION|        P=0.012N*        (e)              (e)              (e)              (e)              P=0.022N*       | 
|COCH-ARM / FISHERS |        P=0.010N*        (e)              (e)              (e)              (e)              P=0.016N*       | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/10 (40%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        4/10.00          0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        40.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        4/10 (40%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/9 (44%)       | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.291          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.431         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|LOGISTIC REGRESSION|        P=0.291          (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.411          P=1.000          P=1.000          P=1.000          P=1.000          P=0.500         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         9/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           90.0%            100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.560          (e)              P=0.500N         (e)              (e)              (e)             | 
|POLY 3             |        P=0.560          (e)              P=0.500N         (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.560          (e)              P=0.500N         (e)              (e)              (e)             | 
|POLY 6             |        P=0.560          (e)              P=0.500N         (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.560          (e)              P=0.500N         (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.561          (e)              P=0.500N         (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.513          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         10/10.00         10/10.00         10/10.00         9/9.59          | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%           93.9%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=1.000N         (e)              (e)              (e)              (e)              P=1.000N        | 
|POLY 3             |        P=0.221N         (e)              (e)              (e)              (e)              P=0.745N        | 
|POLY 1.5           |        P=0.150N         (e)              (e)              (e)              (e)              P=0.613N        | 
|POLY 6             |        P=0.508N         (e)              (e)              (e)              (e)              P=0.962N        | 
|LOGISTIC REGRESSION|        P=1.000N         (e)              (e)              (e)              (e)              P=1.000N        | 
|COCH-ARM / FISHERS |        P=0.105N         (e)              (e)              (e)              (e)              P=0.500N        | 
|ORDER RESTRICTED   |        P=0.060N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Cortex                                                                                                                   | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001N**      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Cortex                                                                                                                   | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          1/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             10.0%            100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              93 (T)           93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.500          P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Regeneration Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       8/10 (80%)       7/10 (70%)       3/10 (30%)       2/10 (20%)       0/10 (0%)       | 
|POLY-3 RATE (b)    |        9/10.00          8/10.00          7/10.00          3/10.00          2/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        90.0%            80.0%            70.0%            30.0%            20.0%            0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        9/10 (90%)       8/10 (80%)       7/10 (70%)       3/10 (30%)       2/10 (20%)       0/10 (0%)       | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001N**       P=0.500N         P=0.293N         P=0.013N*        P=0.004N**       P<0.001N**      | 
|POLY 3             |        P<0.001N**       P=0.500N         P=0.292N         P=0.003N**       P<0.001N**       P<0.001N**      | 
|POLY 1.5           |        P<0.001N**       P=0.500N         P=0.292N         P=0.003N**       P<0.001N**       P<0.001N**      | 
|POLY 6             |        P<0.001N**       P=0.500N         P=0.292N         P=0.003N**       P<0.001N**       P<0.001N**      | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.500N         P=0.293N         P=0.013N*        P=0.004N**       (e)             | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.500N         P=0.291N         P=0.010N*        P=0.003N**       P<0.001N**      | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Regeneration Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/10.00          0/10.00          1/10.00          0/10.00          0/10.00          0/9.59          | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             10.0%            0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        93 (T)           ---              93 (T)           ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.163N         P=0.234N         P=0.500N         P=0.234N         P=0.234N         P=0.257N        | 
|POLY 3             |        P=0.149N         P=0.227N         P=0.500N         P=0.227N         P=0.227N         P=0.236N        | 
|POLY 1.5           |        P=0.149N         P=0.227N         P=0.500N         P=0.227N         P=0.227N         P=0.232N        | 
|POLY 6             |        P=0.148N         P=0.227N         P=0.500N         P=0.227N         P=0.227N         P=0.243N        | 
|LOGISTIC REGRESSION|        P=0.163N         (e)              P=0.500N         (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.153N         P=0.237N         P=0.500N         P=0.237N         P=0.237N         P=0.237N        | 
|ORDER RESTRICTED   |        P=0.029N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        9/10 (90%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          1/10.00          0/10.00          0/10.00          9/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             10.0%            0.0%             0.0%             90.0%            90.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)        9/10 (90%)       9/10 (90%)      | 
|FIRST INCIDENCE    |        ---              93 (T)           ---              ---              93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        2/10.00          0/10.00          1/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             10.0%            100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        2/10 (20%)       0/10 (0%)        1/10 (10%)       10/10 (100%)     10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              93 (T)           93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.234N         P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.227N         P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.227N         P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.227N         P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.500N         P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.237N         P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          2/10.00          0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             20.0%            0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        2/10 (20%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              93 (T)           ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.287N         P=0.234          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.277N         P=0.227          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.277N         P=0.227          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.277N         P=0.227          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              P=0.234          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.285N         P=0.237          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.165N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Necrosis Focal                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.59          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        3/10.00          0/10.00          0/10.00          0/10.00          0/10.00          0/9.59          | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        3/10 (30%)       0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)        | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.115N         P=0.111N         P=0.111N         P=0.111N         P=0.111N         P=0.129N        | 
|POLY 3             |        P=0.083N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.103N        | 
|POLY 1.5           |        P=0.084N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.099N        | 
|POLY 6             |        P=0.082N         P=0.095N         P=0.095N         P=0.095N         P=0.095N         P=0.108N        | 
|LOGISTIC REGRESSION|        P=0.115N         (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.107N         P=0.105N         P=0.105N         P=0.105N         P=0.105N         P=0.105N        | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 13      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          9/10.00          10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             90.0%            100.0%           90.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       10/10 (100%)     9/10 (90%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Kupffer Cell                                                                                                              | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P=0.831          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 14      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Artery                                                                                                                     | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        6/10.00          0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.413N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.413N         (e)              (e)              (e)              (e)              P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.411N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Artery                                                                                                                     | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/9 (44%)       | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.163          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.282         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.329         | 
|LOGISTIC REGRESSION|        P=0.163          (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.247          P=1.000          P=1.000          P=1.000          P=1.000          P=0.325         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 15      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           0/0.00           5/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             50.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         5/10 (50%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.127          P=1.000N         P=1.000          P=1.000N         P=1.000N         P=0.180         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.174         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.174         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.174         | 
|LOGISTIC REGRESSION|        P=0.127          (e)              (e)              (e)              (e)              P=0.180         | 
|COCH-ARM / FISHERS |        P=0.121          P=1.000          P=1.000          P=1.000          P=1.000          P=0.175         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|INT SACRIFICE 1 (c)|                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 16      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|POLY-3 RATE (b)    |        5/10.00          0/0.00           0/0.00           0/0.00           0/0.00           0/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            0.0%             0.0%             0.0%             0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        5/10 (50%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/10 (0%)       | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.012N*        P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.022N*       | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.008N**      | 
|LOGISTIC REGRESSION|        P=0.012N*        (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.010N*        P=1.000          P=1.000          P=1.000          P=1.000          P=0.016N*       | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|INT SACRIFICE 1 (c)|                                                                                                             | 
|TERMINAL (d)       |                                                                                                             | 
|FIRST INCIDENCE    |                                                                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                                             | 
|POLY 3             |                                                                                                             | 
|POLY 1.5           |                                                                                                             | 
|POLY 6             |                                                                                                             | 
|LOGISTIC REGRESSION|                                                                                                             | 
|COCH-ARM / FISHERS |                                                                                                             | 
|ORDER RESTRICTED   |                                                                                                             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 17      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          1/10.00          9/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             10.0%            90.0%            100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        8/10 (80%)       9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          8/10.00          9/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             80.0%            90.0%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        8/10 (80%)       9/10 (90%)       10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              ---              93 (T)           93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              P<0.001 **       P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 18      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        7/10 (70%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          7/10.00          10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             70.0%            100.0%           100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        7/10 (70%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.003 **       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 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P<0.001 **       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 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.003 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.002 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        5/10 (50%)       8/10 (80%)       10/10 (100%)     10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          5/10.00          8/10.00          10/10.00         10/10.00         9/9.59          | 
|POLY-3 PERCENT (g) |        0.0%             50.0%            80.0%            100.0%           100.0%           93.9%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        5/10 (50%)       8/10 (80%)       10/10 (100%)     10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.008 **       P<0.001 **       P<0.001 **       P<0.001N**       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.022 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.016 *        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 19      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          6/10.00          10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             60.0%            100.0%           100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        6/10 (60%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.009 **       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 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P<0.001 **       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 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.009 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.005 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          10/10.00         10/10.00         9/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             100.0%           100.0%           90.0%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     9/9 (100%)      | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P<0.001N**       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P<0.001N**       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P<0.001N**       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 20      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       2/10 (20%)       8/10 (80%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          2/10.00          2/10.00          8/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             20.0%            20.0%            80.0%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        2/10 (20%)       2/10 (20%)       8/10 (80%)       10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.234          P=0.234          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.227          P=0.227          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.227          P=0.227          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.227          P=0.227          P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.234          P=0.234          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.237          P=0.237          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     8/10 (80%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          6/10.00          10/10.00         8/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             60.0%            100.0%           80.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)       10/10 (100%)     7/9 (78%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.009 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P<0.001 **       P<0.001N**       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.009 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.005 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 61529 TEST: 01                                            Page 21      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     M-CHLOROANILINE                    
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Infiltration Cellular                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       2/10 (20%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        1/10.00          2/10.00          2/10.00          10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        10.0%            20.0%            20.0%            100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        1/10 (10%)       2/10 (20%)       2/10 (20%)       10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.500          P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 MG/KG          10 MG/KG         20 MG/KG         40 MG/KG         80 MG/KG         160             | 
|                   |                                                                                             MG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Infiltration Cellular                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       1/10 (10%)       0/10 (0%)        9/10 (90%)       10/10 (100%)     8/10 (80%)      | 
|POLY-3 RATE (b)    |        1/10.00          1/10.00          0/10.00          9/10.00          10/10.00         8/10.00         | 
|POLY-3 PERCENT (g) |        10.0%            10.0%            0.0%             90.0%            100.0%           80.0%           | 
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|TERMINAL (d)       |        1/10 (10%)       1/10 (10%)       0/10 (0%)        9/10 (90%)       10/10 (100%)     7/9 (78%)       | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           ---              93 (T)           93 (T)           78              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.766          P=0.500N         P<0.001 **       P<0.001 **       P=0.004 **      | 
|POLY 3             |        P<0.001 **       P=0.760          P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.760          P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.760          P=0.500N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.766          (e)              P<0.001 **       P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.763N         P=0.500N         P<0.001 **       P<0.001 **       P=0.003 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (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.