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TDMS Study 05203-08 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:16:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 88-72-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                    RATS, FINAL#1; 14 WEEK SSAC                                                     
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 009    2000 PPM(STOP)                                                                
                                       INCLUDE 010    5000 PPM(STOP)                                                                
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:16:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 88-72-2         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  O-NITROTOLUENE                                                                                  
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Epididymis                             Atrophy                                                                                      
                                       Atypia Cellular                                                                              
Islets, Pancreatic                     Hyperplasia                                                                                  
Kidney                                 Nephropathy                                                                                  
Kidney: Renal Tubule                   Degeneration Hyaline                                                                         
Liver: Hepatocyte                      Vacuolization Cytoplasmic                                                                    
Nose: Olfactory Epithelium             Degeneration                                                                                 
Preputial Gland                        Atrophy                                                                                      
Salivary Glands                        Atrophy                                                                                      
Spleen                                 Congestion                                                                                   
                                       Hematopoietic Cell Proliferation                                                             
Testes                                 Mineralization                                                                               
Testes: Germinal Epithelium            Atrophy                                                                                      
===============================================================                                                                     
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 1       
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER 344)  -                   O-NITROTOLUENE 
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Accessory Adrenal Cortical Nodule                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       2/10 (20%)                                                         | 
|POLY-3 RATE (b)    |        1/1.01           2/2.01           2/2.01                                                             | 
|POLY-3 PERCENT (g) |        99.3%            99.7%            99.7%                                                              | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       2/10 (20%)       2/10 (20%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        92 (I)           92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.423          P=0.500          P=0.500                                                            | 
|POLY 3             |        P=0.322          P=0.299          P=0.299                                                            | 
|POLY 1.5           |        P=0.324          P=0.305          P=0.305                                                            | 
|POLY 6             |        P=0.321          P=0.299          P=0.299                                                            | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.421          P=0.500          P=0.500                                                            | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        5/10 (50%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           0/0.01           5/5.00                                                             | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             99.9%                                                              | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        5/10 (50%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       (e)              P=0.022 *                                                          | 
|POLY 3             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.002 **       (e)              P=0.016 *                                                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 2       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Epididymis                                                                                                                       | 
|     Atypia Cellular                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           2/2.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             99.7%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        2/10 (20%)       10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.234          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.067          P=1.000N                                                           | 
|POLY 1.5           |        P<0.001 **       P=0.070          P=1.000N                                                           | 
|POLY 6             |        P<0.001 **       P=0.067          P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.237          P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Cardiomyopathy                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       3/10 (30%)       6/10 (60%)                                                         | 
|POLY-3 RATE (b)    |        5/5.00           3/3.01           6/6.00                                                             | 
|POLY-3 PERCENT (g) |        99.9%            99.8%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        5/10 (50%)       3/10 (30%)       6/10 (60%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        92 (I)           92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.374          P=0.328N         P=0.500                                                            | 
|POLY 3             |        P=0.328          P=0.233N         P=0.422                                                            | 
|POLY 1.5           |        P=0.329          P=0.236N         P=0.424                                                            | 
|POLY 6             |        P=0.328          P=0.233N         P=0.422                                                            | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.372          P=0.325N         P=0.500                                                            | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 3       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        8/10 (80%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           0/0.01           8/8.00                                                             | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        8/10 (80%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        8/10 (80%)       0/10 (0%)                                                          | 
|POLY-3 RATE (b)    |        0/0.01           8/8.00           0/0.01                                                             | 
|POLY-3 PERCENT (g) |        0.0%             100.0%           0.0%                                                               | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        8/10 (80%)       0/10 (0%)                                                          | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           ---                                                                | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.409N         P<0.001 **       (e)                                                                | 
|POLY 3             |        P=0.165N         P<0.001 **       (e)                                                                | 
|POLY 1.5           |        P=0.169N         P<0.001 **       (e)                                                                | 
|POLY 6             |        P=0.165N         P<0.001 **       (e)                                                                | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.407N         P<0.001 **       (e)                                                                | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 4       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Degeneration Hyaline                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        1/1.01           0/0.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        99.3%            0.0%             100.0%                                                             | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       0/10 (0%)        10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        92 (I)           ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500N         P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.159N         P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       P=0.167N         P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       P=0.159N         P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatodiaphragmatic Nodule                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       2/10 (20%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           1/1.01           2/2.01                                                             | 
|POLY-3 PERCENT (g) |        0.0%             99.3%            99.7%                                                              | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        1/10 (10%)       2/10 (20%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.154          P=0.500          P=0.234                                                            | 
|POLY 3             |        P=0.080          P=0.159          P=0.067                                                            | 
|POLY 1.5           |        P=0.082          P=0.167          P=0.070                                                            | 
|POLY 6             |        P=0.080          P=0.159          P=0.067                                                            | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.150          P=0.500          P=0.237                                                            | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 5       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           0/0.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 3             |        P=1.000N         (e)              P=1.000N                                                           | 
|POLY 1.5           |        P=1.000N         (e)              P=1.000N                                                           | 
|POLY 6             |        P=1.000N         (e)              P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Nose: Olfactory Epithelium                                                                                                       | 
|     Degeneration                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        4/10 (40%)       10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           4/4.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             99.9%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        4/10 (40%)       10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.051          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.007 **       P=1.000N                                                           | 
|POLY 1.5           |        P<0.001 **       P=0.008 **       P=1.000N                                                           | 
|POLY 6             |        P<0.001 **       P=0.007 **       P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.043 *        P<0.001 **                                                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 6       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       8/10 (80%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           1/1.01           8/8.00                                                             | 
|POLY-3 PERCENT (g) |        0.0%             99.3%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        1/10 (10%)       8/10 (80%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.159          P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       P=0.167          P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       P=0.159          P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Salivary Glands                                                                                                                  | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        10/10 (100%)     10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           10/10.00         10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             100.0%           100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        10/10 (100%)     10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **                                                         | 
|POLY 3             |        P=1.000N         P=1.000N         P=1.000N                                                           | 
|POLY 1.5           |        P=1.000N         P=1.000N         P=1.000N                                                           | 
|POLY 6             |        P=1.000N         P=1.000N         P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **                                                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 7       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Congestion                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        3/10 (30%)       10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           3/3.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             99.8%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        3/10 (30%)       10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.111          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.025 *        P=1.000N                                                           | 
|POLY 1.5           |        P<0.001 **       P=0.026 *        P=1.000N                                                           | 
|POLY 6             |        P<0.001 **       P=0.025 *        P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.105          P<0.001 **                                                         | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Hematopoietic Cell Proliferation                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       10/10 (100%)                                                       | 
|POLY-3 RATE (b)    |        0/0.01           2/2.01           10/10.00                                                           | 
|POLY-3 PERCENT (g) |        0.0%             99.7%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        2/10 (20%)       10/10 (100%)                                                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.234          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.067          P=1.000N                                                           | 
|POLY 1.5           |        P<0.001 **       P=0.070          P=1.000N                                                           | 
|POLY 6             |        P<0.001 **       P=0.067          P=1.000N                                                           | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.237          P<0.001 **                                                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 8       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Mineralization                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        5/10 (50%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           0/0.01           5/5.00                                                             | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             99.9%                                                              | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        5/10 (50%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.003 **       (e)              P=0.022 *                                                          | 
|POLY 3             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       (e)              P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       (e)              P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.002 **       (e)              P=0.016 *                                                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes: Germinal Epithelium                                                                                                      | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       9/10 (90%)                                                         | 
|POLY-3 RATE (b)    |        0/0.01           1/1.01           9/9.00                                                             | 
|POLY-3 PERCENT (g) |        0.0%             99.3%            100.0%                                                             | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        1/10 (10%)       9/10 (90%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        ---              92 (I)           92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P<0.001 **                                                         | 
|POLY 3             |        P<0.001 **       P=0.159          P<0.001 **                                                         | 
|POLY 1.5           |        P<0.001 **       P=0.167          P<0.001 **                                                         | 
|POLY 6             |        P<0.001 **       P=0.159          P<0.001 **                                                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P<0.001 **                                                         | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 9       
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER 344)  -                   O-NITROTOLUENE  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland                                                                                                                    | 
|     Ultimobranchial Cyst                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/10 (0%)        2/10 (20%)                                                         | 
|POLY-3 RATE (b)    |        1/1.01           0/0.01           2/2.01                                                             | 
|POLY-3 PERCENT (g) |        99.3%            0.0%             99.7%                                                              | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       0/10 (0%)        2/10 (20%)                                                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        92 (I)           ---              92 (I)                                                             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.331          P=0.500N         P=0.500                                                            | 
|POLY 3             |        P=0.207          P=0.159N         P=0.299                                                            | 
|POLY 1.5           |        P=0.208          P=0.167N         P=0.305                                                            | 
|POLY 6             |        P=0.207          P=0.159N         P=0.299                                                            | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.328          P=0.500N         P=0.500                                                            | 
|=================================================================================================================================| 
(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).                                                    

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