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TDMS Study 05205-07 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 01/04/01       
EXPERIMENT: 05205 TEST: 07                                                                                     TIME: 08:27:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 99-99-0         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            Final#2/Rats                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 01/04/01       
EXPERIMENT: 05205 TEST: 07                                                                                     TIME: 08:27:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 99-99-0         
Rats(FISCHER 344)                                                                                                                   
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Prostate                                                                           
                                                 Salivary Glands                                                                    
                                                 Testes                                                                             
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 01/04/01       
EXPERIMENT: 05205 TEST: 07                                                                                     TIME: 08:27:02       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 99-99-0         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF                  P-NITROTOLUENE                                                                                  
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Islets, Pancreatic                     Carcinoma or Adenoma                                                                         
Skin                                   Fibroma                                                                                      
                                       Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
Testes                                 Adenoma                                                                                      
Thyroid Gland: C-Cell                  Adenoma                                                                                      
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Clitoral/Preputial Gland               Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
All Organs                             Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  01/04/01                           EXPERIMENT: 05205 TEST: 07                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                   P-NITROTOLUENE          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            1250         2500         5000        |0            1250         2500         5000         | 
|                   |     PPM          PPM          PPM          PPM         |PPM          PPM          PPM          PPM          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    | 
|POLY-3 RATE (b)    |     0/44.85      0/44.95      1/47.38      2/46.70     |0/45.91      0/46.28      0/47.00      0/48.05      | 
|POLY-3 PERCENT (g) |     0.0%         0.0%         2.1%         4.3%        |0.0%         0.0%         0.0%         0.0%         | 
|TERMINAL (d)       |     0/31 (0%)    0/38 (0%)    1/38 (3%)    1/40 (3%)   |0/39 (0%)    0/37 (0%)    0/39 (0%)    0/41 (0%)    | 
|FIRST INCIDENCE    |     ---          ---          729 (T)      685         |---          ---          ---          ---          | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.088      (e)          P=0.541      P=0.279     |(e)          (e)          (e)          (e)          | 
|POLY 3             |     P=0.075      (e)          P=0.511      P=0.246     |(e)          (e)          (e)          (e)          | 
|POLY 1.5           |     P=0.073      (e)          P=0.507      P=0.242     |(e)          (e)          (e)          (e)          | 
|POLY 6             |     P=0.078      (e)          P=0.516      P=0.252     |(e)          (e)          (e)          (e)          | 
|LOGISTIC REGRESSION|     P=0.073      (e)          P=0.541      P=0.240     |(e)          (e)          (e)          (e)          | 
|COCH-ARM / FISHERS |     P=0.070      (e)          P=0.500      P=0.247     |(e)          (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0            1250         2500         5000        |0            1250         2500         5000         | 
|                   |     PPM          PPM          PPM          PPM         |PPM          PPM          PPM          PPM          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                        |                                                    | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     3/50 (6%)    3/49 (6%)    2/50 (4%)    4/50 (8%)   |2/49 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    | 
|POLY-3 RATE (b)    |     3/45.04      3/43.95      2/47.38      4/46.62     |2/44.91      1/46.28      0/47.00      1/48.05      | 
|POLY-3 PERCENT (g) |     6.7%         6.8%         4.2%         8.6%        |4.5%