National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/16745

TDMS Study 96021-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:05:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     FINAL#4 RATS CTRL VS STOP                                                      
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 007    3000 UG/KG STOP                                                               
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:05:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
Rats(SPRAGUE-DAWLEY)                                                                                                                
-----------------------------                                                                                                       
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                                                                    
                                                 Bone Marrow                                                                        
                                                 Brain                                                                              
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:05:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Islets, Pancreatic                     Carcinoma or Adenoma                                                                         
Liver                                  Cholangioma                                                                                  
Mammary Gland                          Adenoma                                                                                      
                                       Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
                                       Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Skin                                   Fibroma                                                                                      
                                       Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
                                       Fibrosarcoma                                                                                 
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                  
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
Thyroid Gland: Follicular Cell         Adenoma                                                                                      
Uterus                                 Polyp Stromal                                                                                
All Organs                             Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type      
                                       Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -       TOXIC EQUIVALENCY FACTOR EVALUATION (                 
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              2/39.13                                           6/37.40                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              16.0%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              701                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.113                      | 
|POLY 3             |                                                                                P=0.117                      | 
|POLY 1.5           |                                                                                P=0.114                      | 
|POLY 6             |                                                                                P=0.124                      | 
|LOGISTIC REGRESSION|                                                                                P=0.113                      | 
|COCH-ARM / FISHERS |                                                                                P=0.117                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              3/53 (6%)                                         6/50 (12%)                   | 
|POLY-3 RATE (b)    |                              3/39.55                                           6/37.40                      | 
|POLY-3 PERCENT (g) |                              7.6%                                              16.0%                        | 
|TERMINAL (d)       |                              1/24 (4%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              608                                               591                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.208                      | 
|POLY 3             |                                                                                P=0.214                      | 
|POLY 1.5           |                                                                                P=0.210                      | 
|POLY 6             |                                                                                P=0.222                      | 
|LOGISTIC REGRESSION|                                                                                P=0.208                      | 
|COCH-ARM / FISHERS |                                                                                P=0.216                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/39.01                                           2/36.65                      | 
|POLY-3 PERCENT (g) |                              2.6%                                              5.5%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           656                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.458                      | 
|POLY 3             |                                                                                P=0.485                      | 
|POLY 1.5           |                                                                                P=0.483                      | 
|POLY 6             |                                                                                P=0.491                      | 
|LOGISTIC REGRESSION|                                                                                P=0.480                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangioma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/36.38                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.5%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.198                      | 
|POLY 3             |                                                                                P=0.228                      | 
|POLY 1.5           |                                                                                P=0.228                      | 
|POLY 6             |                                                                                P=0.229                      | 
|LOGISTIC REGRESSION|                                                                                P=0.198                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.01                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.278N                     | 
|POLY 3             |                                                                                P=0.260N                     | 
|POLY 1.5           |                                                                                P=0.263N                     | 
|POLY 6             |                                                                                P=0.254N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/53 (15%)                                        10/50 (20%)                  | 
|POLY-3 RATE (b)    |                              8/39.57                                           10/38.41                     | 
|POLY-3 PERCENT (g) |                              20.2%                                             26.0%                        | 
|TERMINAL (d)       |                              6/24 (25%)                                        4/20 (20%)                   | 
|FIRST INCIDENCE    |                              608                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.296                      | 
|POLY 3             |                                                                                P=0.367                      | 
|POLY 1.5           |                                                                                P=0.352                      | 
|POLY 6             |                                                                                P=0.393                      | 
|LOGISTIC REGRESSION|                                                                                P=0.334                      | 
|COCH-ARM / FISHERS |                                                                                P=0.346                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/53 (17%)                                        10/50 (20%)                  | 
|POLY-3 RATE (b)    |                              9/39.57                                           10/38.41                     | 
|POLY-3 PERCENT (g) |                              22.8%                                             26.0%                        | 
|TERMINAL (d)       |                              7/24 (29%)                                        4/20 (20%)                   | 
|FIRST INCIDENCE    |                              608                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.381                      | 
|POLY 3             |                                                                                P=0.472                      | 
|POLY 1.5           |                                                                                P=0.453                      | 
|POLY 6             |                                                                                P=0.502                      | 
|LOGISTIC REGRESSION|                                                                                P=0.432                      | 
|COCH-ARM / FISHERS |                                                                                P=0.444                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       30/50 (60%)                  | 
|POLY-3 RATE (b)    |                              41/49.26                                          30/43.00                     | 
|POLY-3 PERCENT (g) |                              83.2%                                             69.8%                        | 
|TERMINAL (d)       |                              19/24 (79%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              399                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.195N                     | 
|POLY 3             |                                                                                P=0.091N                     | 
|POLY 1.5           |                                                                                P=0.077N                     | 
|POLY 6             |                                                                                P=0.096N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.052N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.045N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 5       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              41/53 (77%)                                       30/50 (60%)                  | 
|POLY-3 RATE (b)    |                              41/49.26                                          30/43.00                     | 
|POLY-3 PERCENT (g) |                              83.2%                                             69.8%                        | 
|TERMINAL (d)       |                              19/24 (79%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              399                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.195N                     | 
|POLY 3             |                                                                                P=0.091N                     | 
|POLY 1.5           |                                                                                P=0.077N                     | 
|POLY 6             |                                                                                P=0.096N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.052N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.045N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              43/53 (81%)                                       37/50 (74%)                  | 
|POLY-3 RATE (b)    |                              43/49.39                                          37/44.76                     | 
|POLY-3 PERCENT (g) |                              87.1%                                             82.7%                        | 
|TERMINAL (d)       |                              20/24 (83%)                                       14/20 (70%)                  | 
|FIRST INCIDENCE    |                              399                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.468N                     | 
|POLY 3             |                                                                                P=0.378N                     | 
|POLY 1.5           |                                                                                P=0.358N                     | 
|POLY 6             |                                                                                P=0.367N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.307N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.264N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 6       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/53 (34%)                                       23/50 (46%)                  | 
|POLY-3 RATE (b)    |                              18/41.75                                          23/39.65                     | 
|POLY-3 PERCENT (g) |                              43.1%                                             58.0%                        | 
|TERMINAL (d)       |                              10/24 (42%)                                       14/20 (70%)                  | 
|FIRST INCIDENCE    |                              211                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.107                      | 
|POLY 3             |                                                                                P=0.120                      | 
|POLY 1.5           |                                                                                P=0.117                      | 
|POLY 6             |                                                                                P=0.131                      | 
|LOGISTIC REGRESSION|                                                                                P=0.125                      | 
|COCH-ARM / FISHERS |                                                                                P=0.148                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/53 (34%)                                       24/50 (48%)                  | 
|POLY-3 RATE (b)    |                              18/41.75                                          24/40.16                     | 
|POLY-3 PERCENT (g) |                              43.1%                                             59.8%                        | 
|TERMINAL (d)       |                              10/24 (42%)                                       14/20 (70%)                  | 
|FIRST INCIDENCE    |                              211                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.080                      | 
|POLY 3             |                                                                                P=0.088                      | 
|POLY 1.5           |                                                                                P=0.082                      | 
|POLY 6             |                                                                                P=0.103                      | 
|LOGISTIC REGRESSION|                                                                                P=0.087                      | 
|COCH-ARM / FISHERS |                                                                                P=0.106                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 7       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           2/37.14                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.4%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               452                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.213                      | 
|POLY 3             |                                                                                P=0.231                      | 
|POLY 1.5           |                                                                                P=0.230                      | 
|POLY 6             |                                                                                P=0.233                      | 
|LOGISTIC REGRESSION|                                                                                P=0.233                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              0/39.01                                           7/38.88                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              18.0%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.008 **                   | 
|POLY 3             |                                                                                P=0.007 **                   | 
|POLY 1.5           |                                                                                P=0.006 **                   | 
|POLY 6             |                                                                                P=0.008 **                   | 
|LOGISTIC REGRESSION|                                                                                P=0.009 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.005 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 8       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              0/39.01                                           4/37.78                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              10.6%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.054                      | 
|POLY 3             |                                                                                P=0.056                      | 
|POLY 1.5           |                                                                                P=0.055                      | 
|POLY 6             |                                                                                P=0.058                      | 
|LOGISTIC REGRESSION|                                                                                P=0.063                      | 
|COCH-ARM / FISHERS |                                                                                P=0.052                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              0/39.01                                           5/38.11                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              13.1%                        | 
|TERMINAL (d)       |                              0/24 (0%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              ---                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.030 *                    | 
|POLY 3             |                                                                                P=0.028 *                    | 
|POLY 1.5           |                                                                                P=0.027 *                    | 
|POLY 6             |                                                                                P=0.030 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.032 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.024 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 9       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              16/51 (31%)                                       18/49 (37%)                  | 
|POLY-3 RATE (b)    |                              16/39.99                                          18/37.75                     | 
|POLY-3 PERCENT (g) |                              40.0%                                             47.7%                        | 
|TERMINAL (d)       |                              10/24 (42%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              555                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.260                      | 
|POLY 3             |                                                                                P=0.323                      | 
|POLY 1.5           |                                                                                P=0.324                      | 
|POLY 6             |                                                                                P=0.329                      | 
|LOGISTIC REGRESSION|                                                                                P=0.327                      | 
|COCH-ARM / FISHERS |                                                                                P=0.361                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/51 (4%)                                         3/49 (6%)                    | 
|POLY-3 RATE (b)    |                              2/38.11                                           3/36.14                      | 
|POLY-3 PERCENT (g) |                              5.3%                                              8.3%                         | 
|TERMINAL (d)       |                              2/24 (8%)                                         1/20 (5%)                    | 
|FIRST INCIDENCE    |                              731 (T)                                           669                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.444                      | 
|POLY 3             |                                                                                P=0.480                      | 
|POLY 1.5           |                                                                                P=0.477                      | 
|POLY 6             |                                                                                P=0.489                      | 
|LOGISTIC REGRESSION|                                                                                P=0.477                      | 
|COCH-ARM / FISHERS |                                                                                P=0.481                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 10      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              18/51 (35%)                                       19/49 (39%)                  | 
|POLY-3 RATE (b)    |                              18/39.99                                          19/37.90                     | 
|POLY-3 PERCENT (g) |                              45.0%                                             50.1%                        | 
|TERMINAL (d)       |                              12/24 (50%)                                       11/20 (55%)                  | 
|FIRST INCIDENCE    |                              555                                               437                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.317                      | 
|POLY 3             |                                                                                P=0.410                      | 
|POLY 1.5           |                                                                                P=0.404                      | 
|POLY 6             |                                                                                P=0.430                      | 
|LOGISTIC REGRESSION|                                                                                P=0.406                      | 
|COCH-ARM / FISHERS |                                                                                P=0.439                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/51 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/38.11                                           2/35.75                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.6%                         | 
|TERMINAL (d)       |                              0/24 (0%)                                         2/20 (10%)                   | 
|FIRST INCIDENCE    |                              ---                                               731 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.198                      | 
|POLY 3             |                                                                                P=0.229                      | 
|POLY 1.5           |                                                                                P=0.229                      | 
|POLY 6             |                                                                                P=0.230                      | 
|LOGISTIC REGRESSION|                                                                                P=0.198                      | 
|COCH-ARM / FISHERS |                                                                                P=0.238                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 11      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              7/53 (13%)                                        4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              7/39.74                                           4/37.16                      | 
|POLY-3 PERCENT (g) |                              17.6%                                             10.8%                        | 
|TERMINAL (d)       |                              4/24 (17%)                                        1/20 (5%)                    | 
|FIRST INCIDENCE    |                              590                                               624                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.324N                     | 
|POLY 3             |                                                                                P=0.301N                     | 
|POLY 1.5           |                                                                                P=0.309N                     | 
|POLY 6             |                                                                                P=0.287N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.297N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.298N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/39.53                                           0/36.38                      | 
|POLY-3 PERCENT (g) |                              5.1%                                              0.0%                         | 
|TERMINAL (d)       |                              1/24 (4%)                                         0/20 (0%)                    | 
|FIRST INCIDENCE    |                              571                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.263N                     | 
|POLY 3             |                                                                                P=0.265N                     | 
|POLY 1.5           |                                                                                P=0.266N                     | 
|POLY 6             |                                                                                P=0.263N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.252N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 12      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              50/53 (94%)                                       44/50 (88%)                  | 
|POLY-3 RATE (b)    |                              50/51.13                                          44/45.72                     | 
|POLY-3 PERCENT (g) |                              97.8%                                             96.2%                        | 
|TERMINAL (d)       |                              24/24 (100%)                                      19/20 (95%)                  | 
|FIRST INCIDENCE    |                              211                                               360                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.520N                     | 
|POLY 3             |                                                                                P=0.593N                     | 
|POLY 1.5           |                                                                                P=0.520N                     | 
|POLY 6             |                                                                                P=0.561N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.341N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.216N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       23/50 (46%)                  | 
|POLY-3 RATE (b)    |                              12/41.43                                          23/43.60                     | 
|POLY-3 PERCENT (g) |                              29.0%                                             52.8%                        | 
|TERMINAL (d)       |                              7/24 (29%)                                        7/20 (35%)                   | 
|FIRST INCIDENCE    |                              442                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.017 *                    | 
|POLY 3             |                                                                                P=0.018 *                    | 
|POLY 1.5           |                                                                                P=0.014 *                    | 
|POLY 6             |                                                                                P=0.026 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.012 *                    | 
|COCH-ARM / FISHERS |                                                                                P=0.011 *                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 13      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 UG/KG                                           3000 UG/                     | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              52/53 (98%)                                       49/50 (98%)                  | 
|POLY-3 RATE (b)    |                              52/52.21                                          49/50.00                     | 
|POLY-3 PERCENT (g) |                              99.6%                                             98.0%                        | 
|TERMINAL (d)       |                              24/24 (100%)                                      19/20 (95%)                  | 
|FIRST INCIDENCE    |                              211                                               183                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.420                      | 
|POLY 3             |                                                                                P=0.581N                     | 
|POLY 1.5           |                                                                                P=0.658N                     | 
|POLY 6             |                                                                                P=0.518N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.763N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.738N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.