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TDMS Study 91001-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                      O-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 91001 TEST: 01                                                                                     TIME: 13:23:01       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: C91001       
PATHOLOGIST: R. PERSING                      ELWELL, MICHAEL                 LE                                CAS: 95-51-2         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    10 MG/KG                                                                      
                                       INCLUDE 004    10 MG/KG                                                                      
                                       INCLUDE 005    20 MG/KG                                                                      
                                       INCLUDE 006    20 MG/KG                                                                      
                                       INCLUDE 007    40 MG/KG                                                                      
                                       INCLUDE 008    40 MG/KG                                                                      
                                       INCLUDE 009    80 MG/KG                                                                      
                                       INCLUDE 010    80 MG/KG                                                                      
                                       INCLUDE 011    160     MG/KG                                                                 
                                       INCLUDE 012    160     MG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                      O-CHLOROANILINE                                    DATE: 10/20/04       
EXPERIMENT: 91001 TEST: 01                                                                                     TIME: 13:23:01       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: N01-ES-15320                              ROUTE: GAVAGE                                                  NTP C#: C91001       
PATHOLOGIST: R. PERSING                      ELWELL, MICHAEL                 LE                                CAS: 95-51-2         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                    O-CHLOROANILINE                                                                               
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Bone Marrow: Erythroid Cell            Hyperplasia                                                                                  
Kidney: Cortex                         Pigmentation Diffuse Hemosiderin                                                             
Liver                                  Pigmentation Hemosiderin                                                                     
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
Spleen: Capsule                        Fibrosis                                                                                     
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Bone Marrow: Erythroid Cell            Hyperplasia                                                                                  
Kidney: Cortex                         Pigmentation Diffuse Hemosiderin                                                             
Liver                                  Pigmentation Hemosiderin                                                                     
Spleen                                 Hematopoietic Cell Proliferation                                                             
                                       Pigmentation Hemosiderin                                                                     
Spleen: Capsule                        Fibrosis                                                                                     
===============================================================                                                                     
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                     O-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%)        1/10 (10%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          1/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             10.0%            100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              12               93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.500          P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.500          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: Erythroid Cell                                                                                                      | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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          0/9.09           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%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                                                                                                             | 
|POLY-3 RATE (b)    |                                                                                                             | 
|POLY-3 PERCENT (g) |                                                                                                             | 
|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                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        3/10.00          0/0.00           0/0.09           0/0.00           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        30.0%            0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.207N         P=1.000N         P=1.000          P=1.000N         P=1.000N         P=0.293N        | 
|POLY 3             |        (e)              (e)              P=0.838N         (e)              (e)              P=0.292N        | 
|POLY 1.5           |        (e)              (e)              P=0.809N         (e)              (e)              P=0.292N        | 
|POLY 6             |        (e)              (e)              P=0.849N         (e)              (e)              P=0.292N        | 
|LOGISTIC REGRESSION|        P=0.207N         (e)              (e)              (e)              (e)              P=0.293N        | 
|COCH-ARM / FISHERS |        P=0.223N         P=1.000          P=0.727N         P=1.000          P=1.000          P=0.291N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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: Myocardium                                                                                                                | 
|     Degeneration Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/1 (0%)         0/0 (0%)         2/10 (20%)      | 
|POLY-3 RATE (b)    |        2/10.00          0/0.00           0/0.00           0/0.00           0/0.00           2/10.00         | 
|POLY-3 PERCENT (g) |        20.0%            0.0%             0.0%             0.0%             0.0%             20.0%           | 
|TERMINAL (d)       |        2/10 (20%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.607          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.707         | 
|POLY 3             |        (e)              (e)              (e)              P=0.882N         (e)              P=0.702         | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.879N         (e)              P=0.702         | 
|POLY 6             |        (e)              (e)              (e)              P=0.882N         (e)              P=0.702         | 
|LOGISTIC REGRESSION|        P=0.607          (e)              (e)              (e)              (e)              P=0.707         | 
|COCH-ARM / FISHERS |        P=0.591          P=1.000          P=1.000          P=0.818N         P=1.000          P=0.709N        | 
|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: Myocardium                                                                                                                | 
|     Degeneration Chronic Focal                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.09           0/0.00           0/0.00           1/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             10.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         1/10 (10%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.309          (e)              (e)              (e)              (e)              P=0.500         | 
|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|        (e)              (e)              (e)              (e)              (e)              P=0.500         | 
|COCH-ARM / FISHERS |        P=0.289          (e)              (e)              (e)              (e)              P=0.500         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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 Diffuse                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        9/10.00          10/10.00         10/10.00         10/10.00         10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        90.0%            100.0%           100.0%           100.0%           100.0%           90.0%           | 
|TERMINAL (d)       |        9/10 (90%)       10/10 (100%)     10/10 (100%)     9/9 (100%)       10/10 (100%)     9/10 (90%)      | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           93 (T)           12               93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.384N         P=0.500          P=0.500          P=0.251          P=0.500          P=0.766         | 
|POLY 3             |        P=0.415N         P=0.500          P=0.500          P=0.500          P=0.500          P=0.760         | 
|POLY 1.5           |        P=0.415N         P=0.500          P=0.500          P=0.500          P=0.500          P=0.760         | 
|POLY 6             |        P=0.415N         P=0.500          P=0.500          P=0.500          P=0.500          P=0.760         | 
|LOGISTIC REGRESSION|        P=0.384N         P=0.500          P=0.500          (e)              P=0.500          P=0.766         | 
|COCH-ARM / FISHERS |        P=0.414N         P=0.500          P=0.500          P=0.500          P=0.500          P=0.763N        | 
|ORDER RESTRICTED   |        P=0.292          (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 Diffuse                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        10/10.00         10/10.00         9/10.00          10/10.00         10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           90.0%            100.0%           100.0%           90.0%           | 
|TERMINAL (d)       |        10/10 (100%)     10/10 (100%)     8/9 (89%)        10/10 (100%)     10/10 (100%)     9/10 (90%)      | 
|FIRST INCIDENCE    |        93 (T)           93 (T)           42               93 (T)           93 (T)           93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.239N         (e)              P=0.749N         (e)              (e)              P=0.500N        | 
|POLY 3             |        P=0.318N         (e)              P=0.500N         (e)              (e)              P=0.500N        | 
|POLY 1.5           |        P=0.318N         (e)              P=0.500N         (e)              (e)              P=0.500N        | 
|POLY 6             |        P=0.318N         (e)              P=0.500N         (e)              (e)              P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.239N         (e)              (e)              (e)              (e)              P=0.500N        | 
|COCH-ARM / FISHERS |        P=0.315N         (e)              P=0.500N         (e)              (e)              P=0.500N        | 
|ORDER RESTRICTED   |        P=0.191N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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 Diffuse Hemosiderin                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              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           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Cortex                                                                                                                   | 
|     Pigmentation Diffuse Hemosiderin                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/9.09           0/10.00          0/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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 Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/1 (0%)         0/1 (0%)         0/0 (0%)         10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/1.00           0/0.00           0/0.00           10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|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 Hemosiderin                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/0 (0%)         0/1 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/0.00           0/0.09           0/0.00           0/0.00           10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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)        |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/1 (0%)         0/0 (0%)         6/10 (60%)      | 
|POLY-3 RATE (b)    |        6/10.00          0/0.00           0/0.00           0/0.00           0/0.00           6/10.00         | 
|POLY-3 PERCENT (g) |        60.0%            0.0%             0.0%             0.0%             0.0%             60.0%           | 
|TERMINAL (d)       |        6/10 (60%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         6/10 (60%)      | 
|FIRST INCIDENCE    |        93 (T)           ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.588          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.672         | 
|POLY 3             |        (e)              (e)              (e)              P=0.833N         (e)              P=0.667         | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.821N         (e)              P=0.667         | 
|POLY 6             |        (e)              (e)              (e)              P=0.834N         (e)              P=0.667         | 
|LOGISTIC REGRESSION|        P=0.588          (e)              (e)              (e)              (e)              P=0.672         | 
|COCH-ARM / FISHERS |        P=0.538          P=1.000          P=1.000          P=0.455N         P=1.000          P=0.675N        | 
|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) |                                                                                                             | 
|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: 91001 TEST: 01                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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%)        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          0/9.00           10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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          0/9.09           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%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           0/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             90.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        9/10 (90%)      | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              93 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              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%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        9/10 (90%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/9.09           0/10.00          9/10.00          9/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             90.0%            90.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (0%)         0/10 (0%)        9/10 (90%)       9/10 (90%)      | 
|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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/20/04                           EXPERIMENT: 91001 TEST: 01                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                     O-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%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/9.00           10/10.00         9/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           90.0%           | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/9 (0%)         10/10 (100%)     9/10 (90%)      | 
|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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen: Capsule                                                                                                                  | 
|     Fibrosis                                                                                                                    | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|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          0/9.09           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%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/9 (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<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|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)             | 
|=================================================================================================================================| 
(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).