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TDMS Study 05203-08 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:37:57       
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         
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                                        RATS, FINAL#1; CONTROL + 2000 & 5000PPM STOP GROUPS                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal 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 PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:37:57       
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         
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 Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Prostate                                                                           
                                                 Salivary Glands                                                                    
                                                 Spleen                                                                             
                                                 Testes                                                                             
                                                 Thyroid Gland                                                                      
                                                 Urinary Bladder                                                                    
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:37:57       
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                                                                                    
-----                                 ----------                                                                                    
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Bone                                   Osteosarcoma                                                                                 
Clitoral/Preputial Gland               Carcinoma or Adenoma                                                                         
Intestine Large: Colon/Rectum          Polyp Adenomatous                                                                            
Liver                                  Cholangiocarcinoma                                                                           
                                       Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Lung                                   Alveolar/Bronchiolar Adenoma                                                                 
                                       Alveolar/Bronchiolar Carcinoma                                                               
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                               
Mammary Gland                          Fibroadenoma                                                                                 
Mesentery                              Fibrosarcoma                                                                                 
Pancreas                               Adenoma                                                                                      
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
Skin                                   Fibroma                                                                                      
                                       Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
                                       Fibrosarcoma                                                                                 
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                  
                                       Keratoacanthoma                                                                              
                                       Lipoma                                                                                       
                                       Schwannoma Malignant                                                                         
                                       Squamous Cell Papilloma                                                                      
Testes                                 Adenoma                                                                                      
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
All Organs                             Hemangioma                                                                                   
                                       Hemangiosarcoma or Hemangioma                                                                
                                       Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                           
                                       Mesothelioma: Benign, Malignant, NOS                                                         
                                       Mesothelioma: Malignant                                                                      
                                       Osteosarcoma                                                                                 
                                       Osteosarcoma or Osteoma                                                                      
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
===============================================================                                                                     
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)        -                   O-NITROTOLUENE          
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/60 (3%)        4/60 (7%)        2/60 (3%)                                                          | 
|POLY-3 RATE (b)    |        2/53.85          4/39.45          2/20.31                                                            | 
|POLY-3 PERCENT (g) |        3.7%             10.1%            9.9%                                                               | 
|TERMINAL (d)       |        2/39 (5%)        2/11 (18%)       0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        729 (T)          569              567                                                                | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.043 *        P=0.011 *                                                          | 
|POLY 3             |        P=0.187          P=0.210          P=0.352                                                            | 
|POLY 1.5           |        P=0.347          P=0.260          P=0.495                                                            | 
|POLY 6             |        P=0.080          P=0.152          P=0.228                                                            | 
|LOGISTIC REGRESSION|        P=0.115          P=0.171          P=0.251                                                            | 
|COCH-ARM / FISHERS |        P=0.558N         P=0.340          P=0.691N                                                           | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Malignant                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/60 (3%)        1/60 (2%)        0/60 (0%)                                                          | 
|POLY-3 RATE (b)    |        2/53.85          1/38.63          0/19.33                                                            | 
|POLY-3 PERCENT (g) |        3.7%             2.6%             0.0%                                                               | 
|TERMINAL (d)       |        2/39 (5%)        1/11 (9%)        0/0 (0%)                                                           | 
|FIRST INCIDENCE    |        729 (T)          729 (T)          ---                                                                | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.720          P=0.590          P=1.000N                                                           | 
|POLY 3             |        P=0.401N         P=0.612N         P=0.485N                                                           | 
|POLY 1.5           |        P=0.256N         P=0.565N         P=0.373N                                                           | 
|POLY 6             |        P=0.614N         P=0.674N         P=0.603N                                                           | 
|LOGISTIC REGRESSION|        P=0.720          P=0.590          (e)                                                                | 
|COCH-ARM / FISHERS |        P=0.161N         P=0.500N         P=0.248N                                                           | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/16/00                           EXPERIMENT: 05203 TEST: 08                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(FISCHER 344)       -                   O-NITROTOLUENE           
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            2000 PPM         5000 PPM                                                           | 
|                   |                         (STOP)           (STOP)                                                             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |