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TDMS Study 96007-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:15:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                 FINAL #3/CONTROL VS. GRPS. 3,4 & 5                                                 
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 003    30 NG/KG                                                                      
                                       INCLUDE 004    100     NG/KG                                                                 
                                       INCLUDE 005    175     NG/KG                                                                 
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:15:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
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 Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 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-126)                    DATE: 10/01/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:15:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
                                                                                                                                    
                                                                                                                                    
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                                            
Brain                                  Astrocytoma Malignant                                                                        
                                       Oligodendroglioma, Glioma, or Astrocytoma                                                    
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Uterus                                 Sarcoma Stromal                                                                              
All Organs                             Benign Tumors                                                                                
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -       TOXIC EQUIVALENCY FACTOR EVALUATION (                 
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               3/55 (5%)                4/53 (8%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  8/33.26                  3/38.95                  4/40.27                  2/37.58         | 
|POLY-3 PERCENT (g) |                  24.1%                    7.7%                     9.9%                     5.3%            | 
|TERMINAL (d)       |                  3/15 (20%)               2/25 (8%)                2/26 (8%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  531                      607                      586                      660             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.032N*                P=0.028N*                P=0.050N                 P=0.020N*       | 
|POLY 3             |                  P=0.045N*                P=0.052N                 P=0.093N                 P=0.025N*       | 
|POLY 1.5           |                  P=0.045N*                P=0.064N                 P=0.115N                 P=0.028N*       | 
|POLY 6             |                  P=0.050N                 P=0.039N*                P=0.072N                 P=0.022N*       | 
|LOGISTIC REGRESSION|                  P=0.038N*                P=0.052N                 P=0.097N                 P=0.025N*       | 
|COCH-ARM / FISHERS |                  P=0.059N                 P=0.084N                 P=0.170N                 P=0.043N*       | 
|ORDER RESTRICTED   |                  P=0.010N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  8/52 (15%)               3/55 (5%)                5/53 (9%)                3/53 (6%)       | 
|POLY-3 RATE (b)    |                  8/33.26                  3/38.95                  5/40.34                  3/38.25         | 
|POLY-3 PERCENT (g) |                  24.1%                    7.7%                     12.4%                    7.8%            | 
|TERMINAL (d)       |                  3/15 (20%)               2/25 (8%)                2/26 (8%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  531                      607                      586                      500             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.091N                 P=0.028N*                P=0.086N                 P=0.048N*       | 
|POLY 3             |                  P=0.115N                 P=0.052N                 P=0.158N                 P=0.055N        | 
|POLY 1.5           |                  P=0.117N                 P=0.064N                 P=0.191N                 P=0.064N        | 
|POLY 6             |                  P=0.122N                 P=0.039N*                P=0.126N                 P=0.050N        | 
|LOGISTIC REGRESSION|                  P=0.108N                 P=0.052N                 P=0.158N                 P=0.064N        | 
|COCH-ARM / FISHERS |                  P=0.146N                 P=0.084N                 P=0.265N                 P=0.095N        | 
|ORDER RESTRICTED   |                  P=0.029N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Astrocytoma Malignant                                                                                                       | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/55 (0%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.82                  0/38.53                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  6.3%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  600                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.091N                 P=0.165N                 P=0.156N                 P=0.183N        | 
|POLY 3             |                  P=0.125N                 P=0.196N                 P=0.191N                 P=0.202N        | 
|POLY 1.5           |                  P=0.119N                 P=0.209N                 P=0.206N                 P=0.211N        | 
|POLY 6             |                  P=0.138N                 P=0.179N                 P=0.176N                 P=0.196N        | 
|LOGISTIC REGRESSION|                  P=0.101N                 P=0.197N                 P=0.194N                 P=0.202N        | 
|COCH-ARM / FISHERS |                  P=0.115N                 P=0.238N                 P=0.248N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.019N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Brain                                                                                                                            | 
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  3/53 (6%)                0/55 (0%)                0/53 (0%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  3/32.80                  0/38.53                  0/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  9.2%                     0.0%                     0.0%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  201                      ---                      ---                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.041N*                P=0.082N                 P=0.079N                 P=0.093N        | 
|POLY 3             |                  P=0.053N                 P=0.091N                 P=0.088N                 P=0.096N        | 
|POLY 1.5           |                  P=0.050N                 P=0.100N                 P=0.098N                 P=0.101N        | 
|POLY 6             |                  P=0.060N                 P=0.079N                 P=0.077N                 P=0.091N        | 
|LOGISTIC REGRESSION|                  P=0.065N                 P=0.128N                 P=0.156N                 P=0.155N        | 
|COCH-ARM / FISHERS |                  P=0.051N                 P=0.115N                 P=0.121N                 P=0.121N        | 
|ORDER RESTRICTED   |                  P=0.005N**               (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/54 (2%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.37                  1/37.81                  2/40.29                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/24 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      652                      602                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.601N                 P=0.578                  P=0.312                  (e)             | 
|POLY 3             |                  P=0.579N                 P=0.537                  P=0.296                  (e)             | 
|POLY 1.5           |                  P=0.591N                 P=0.523                  P=0.275                  (e)             | 
|POLY 6             |                  P=0.577N                 P=0.558                  P=0.325                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.616N                 P=0.526                  P=0.253                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.624                  P=0.509                  P=0.252                  (e)             | 
|ORDER RESTRICTED   |                  P=0.352N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Jejunum                                                                                                         | 
|     Leiomyosarcoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  2/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     5.1%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                2/26 (8%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.505                  (e)                      P=0.365                  (e)             | 
|POLY 3             |                  P=0.499                  (e)                      P=0.292                  (e)             | 
|POLY 1.5           |                  P=0.495                  (e)                      P=0.272                  (e)             | 
|POLY 6             |                  P=0.493                  (e)                      P=0.317                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.365                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.454                  (e)                      P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.294                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Intestine Small: Site Unspecified                                                                                                | 
|     Leiomyosarcoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  2/39.60                  0/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     5.1%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                2/26 (8%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      727 (T)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.505                  (e)                      P=0.365                  (e)             | 
|POLY 3             |                  P=0.499                  (e)                      P=0.292                  (e)             | 
|POLY 1.5           |                  P=0.495                  (e)                      P=0.272                  (e)             | 
|POLY 6             |                  P=0.493                  (e)                      P=0.317                  (e)             | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      P=0.365                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.454                  (e)                      P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.294                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                2/54 (4%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  2/38.32                  0/39.60                  1/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      652                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.599N                 P=0.343                  (e)                      P=0.576         | 
|POLY 3             |                  P=0.589N                 P=0.283                  (e)                      P=0.535         | 
|POLY 1.5           |                  P=0.610N                 P=0.265                  (e)                      P=0.526         | 
|POLY 6             |                  P=0.568N                 P=0.312                  (e)                      P=0.543         | 
|LOGISTIC REGRESSION|                  P=0.617N                 P=0.292                  (e)                      P=0.576         | 
|COCH-ARM / FISHERS |                  P=0.608                  P=0.257                  (e)                      P=0.505         | 
|ORDER RESTRICTED   |                  P=0.360                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 5       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                2/54 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.36                  2/38.32                  1/40.08                  1/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.2%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      652                      586                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.581                  P=0.343                  P=0.551                  P=0.576         | 
|POLY 3             |                  P=0.594                  P=0.283                  P=0.548                  P=0.535         | 
|POLY 1.5           |                  P=0.575                  P=0.265                  P=0.532                  P=0.526         | 
|POLY 6             |                  P=0.616                  P=0.312                  P=0.568                  P=0.543         | 
|LOGISTIC REGRESSION|                  P=0.557                  P=0.292                  P=0.494                  P=0.576         | 
|COCH-ARM / FISHERS |                  P=0.524                  P=0.257                  P=0.505                  P=0.505         | 
|ORDER RESTRICTED   |                  P=0.318                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney: Renal Tubule                                                                                                             | 
|     Nephroblastoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                2/55 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  1/32.37                  2/40.46                  1/40.57                  1/38.09         | 
|POLY-3 PERCENT (g) |                  3.1%                     4.9%                     2.5%                     2.6%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  176                      223                      236                      448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.456N                 P=0.525                  P=0.749N                 P=0.741N        | 
|POLY 3             |                  P=0.433N                 P=0.577                  P=0.708N                 P=0.724N        | 
|POLY 1.5           |                  P=0.446N                 P=0.551                  P=0.727N                 P=0.735N        | 
|POLY 6             |                  P=0.429N                 P=0.611                  P=0.685N                 P=0.713N        | 
|LOGISTIC REGRESSION|                  P=0.368                  P=0.422                  P=0.497                  P=0.581         | 
|COCH-ARM / FISHERS |                  P=0.482N                 P=0.514                  P=0.752N                 P=0.752N        | 
|ORDER RESTRICTED   |                  P=0.567N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 6       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                2/55 (4%)                1/53 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  1/31.38                  2/38.81                  1/40.03                  0/37.32         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.2%                     2.5%                     0.0%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  652                      602                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.167N                 P=0.661                  P=0.664N                 P=0.424N        | 
|POLY 3             |                  P=0.175N                 P=0.574                  P=0.704N                 P=0.465N        | 
|POLY 1.5           |                  P=0.185N                 P=0.548                  P=0.725N                 P=0.475N        | 
|POLY 6             |                  P=0.171N                 P=0.610                  P=0.677N                 P=0.457N        | 
|LOGISTIC REGRESSION|                  P=0.184N                 P=0.616                  P=0.723N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.214N                 P=0.514                  P=0.752N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.237N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                2/55 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  1/31.38                  2/38.81                  1/40.03                  1/37.32         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.2%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  652                      602                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.411N                 P=0.661                  P=0.664N                 P=0.675N        | 
|POLY 3             |                  P=0.427N                 P=0.574                  P=0.704N                 P=0.722N        | 
|POLY 1.5           |                  P=0.441N                 P=0.548                  P=0.725N                 P=0.732N        | 
|POLY 6             |                  P=0.423N                 P=0.610                  P=0.677N                 P=0.711N        | 
|LOGISTIC REGRESSION|                  P=0.435N                 P=0.616                  P=0.723N                 P=0.675N        | 
|COCH-ARM / FISHERS |                  P=0.482N                 P=0.514                  P=0.752N                 P=0.752N        | 
|ORDER RESTRICTED   |                  P=0.559N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 7       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/53 (2%)                2/55 (4%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  1/31.38                  2/38.81                  1/40.03                  1/37.32         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.2%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                1/25 (4%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  727 (T)                  652                      602                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.411N                 P=0.661                  P=0.664N                 P=0.675N        | 
|POLY 3             |                  P=0.427N                 P=0.574                  P=0.704N                 P=0.722N        | 
|POLY 1.5           |                  P=0.441N                 P=0.548                  P=0.725N                 P=0.732N        | 
|POLY 6             |                  P=0.423N                 P=0.610                  P=0.677N                 P=0.711N        | 
|LOGISTIC REGRESSION|                  P=0.435N                 P=0.616                  P=0.723N                 P=0.675N        | 
|COCH-ARM / FISHERS |                  P=0.482N                 P=0.514                  P=0.752N                 P=0.752N        | 
|ORDER RESTRICTED   |                  P=0.559N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/55 (0%)                2/53 (4%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  2/31.38                  0/38.53                  2/40.21                  0/37.32         | 
|POLY-3 PERCENT (g) |                  6.4%                     0.0%                     5.0%                     0.0%            | 
|TERMINAL (d)       |                  2/15 (13%)               0/25 (0%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  727 (T)                  ---                      533                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.250N                 P=0.134N                 P=0.523N                 P=0.157N        | 
|POLY 3             |                  P=0.304N                 P=0.193N                 P=0.602N                 P=0.200N        | 
|POLY 1.5           |                  P=0.297N                 P=0.208N                 P=0.636N                 P=0.210N        | 
|POLY 6             |                  P=0.327N                 P=0.174N                 P=0.560N                 P=0.190N        | 
|LOGISTIC REGRESSION|                  P=0.274N                 (e)                      P=0.608N                 (e)             | 
|COCH-ARM / FISHERS |                  P=0.311N                 P=0.238N                 P=0.691N                 P=0.248N        | 
|ORDER RESTRICTED   |                  P=0.091N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 8       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  6/53 (11%)               7/55 (13%)               9/53 (17%)               5/53 (9%)       | 
|POLY-3 RATE (b)    |                  6/32.44                  7/39.35                  9/40.77                  5/38.47         | 
|POLY-3 PERCENT (g) |                  18.5%                    17.8%                    22.1%                    13.0%           | 
|TERMINAL (d)       |                  3/15 (20%)               3/25 (12%)               6/26 (23%)               3/22 (14%)      | 
|FIRST INCIDENCE    |                  400                      580                      533                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.302N                 P=0.397N                 P=0.557N                 P=0.299N        | 
|POLY 3             |                  P=0.348N                 P=0.591N                 P=0.466                  P=0.379N        | 
|POLY 1.5           |                  P=0.371N                 P=0.598                  P=0.399                  P=0.413N        | 
|POLY 6             |                  P=0.346N                 P=0.514N                 P=0.551                  P=0.347N        | 
|LOGISTIC REGRESSION|                  P=0.362N                 P=0.569N                 P=0.474                  P=0.397N        | 
|COCH-ARM / FISHERS |                  P=0.470N                 P=0.529                  P=0.289                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.387N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  7/53 (13%)               7/55 (13%)               10/53 (19%)              5/53 (9%)       | 
|POLY-3 RATE (b)    |                  7/32.44                  7/39.35                  10/40.77                 5/38.47         | 
|POLY-3 PERCENT (g) |                  21.6%                    17.8%                    24.5%                    13.0%           | 
|TERMINAL (d)       |                  4/15 (27%)               3/25 (12%)               7/26 (27%)               3/22 (14%)      | 
|FIRST INCIDENCE    |                  400                      580                      533                      496             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.243N                 P=0.270N                 P=0.496N                 P=0.191N        | 
|POLY 3             |                  P=0.291N                 P=0.459N                 P=0.493                  P=0.259N        | 
|POLY 1.5           |                  P=0.313N                 P=0.514N                 P=0.419                  P=0.292N        | 
|POLY 6             |                  P=0.292N                 P=0.376N                 P=0.586                  P=0.228N        | 
|LOGISTIC REGRESSION|                  P=0.298N                 P=0.426N                 P=0.522                  P=0.271N        | 
|COCH-ARM / FISHERS |                  P=0.411N                 P=0.583N                 P=0.299                  P=0.380N        | 
|ORDER RESTRICTED   |                  P=0.297N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 9       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  39/53 (74%)              31/55 (56%)              35/53 (66%)              38/53 (72%)     | 
|POLY-3 RATE (b)    |                  39/45.19                 31/45.30                 35/47.68                 38/47.78        | 
|POLY-3 PERCENT (g) |                  86.3%                    68.4%                    73.4%                    79.5%           | 
|TERMINAL (d)       |                  11/15 (73%)              18/25 (72%)              18/26 (69%)              16/22 (73%)     | 
|FIRST INCIDENCE    |                  309                      356                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.272N                 P=0.003N**               P=0.010N*                P=0.095N        | 
|POLY 3             |                  P=0.474N                 P=0.029N*                P=0.085N                 P=0.263N        | 
|POLY 1.5           |                  P=0.496N                 P=0.027N*                P=0.095N                 P=0.274N        | 
|POLY 6             |                  P=0.523N                 P=0.033N*                P=0.101N                 P=0.318N        | 
|LOGISTIC REGRESSION|                  P=0.512                  P=0.015N*                P=0.127N                 P=0.283N        | 
|COCH-ARM / FISHERS |                  P=0.333                  P=0.047N*                P=0.263N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.099N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  40/53 (75%)              31/55 (56%)              36/53 (68%)              38/53 (72%)     | 
|POLY-3 RATE (b)    |                  40/45.19                 31/45.30                 36/48.29                 38/47.78        | 
|POLY-3 PERCENT (g) |                  88.5%                    68.4%                    74.6%                    79.5%           | 
|TERMINAL (d)       |                  12/15 (80%)              18/25 (72%)              18/26 (69%)              16/22 (73%)     | 
|FIRST INCIDENCE    |                  309                      356                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.243N                 P=0.002N**               P=0.009N**               P=0.070N        | 
|POLY 3             |                  P=0.400N                 P=0.013N*                P=0.058N                 P=0.165N        | 
|POLY 1.5           |                  P=0.431N                 P=0.013N*                P=0.074N                 P=0.182N        | 
|POLY 6             |                  P=0.439N                 P=0.014N*                P=0.062N                 P=0.203N        | 
|LOGISTIC REGRESSION|                  P=0.506N                 P=0.008N**               P=0.118N                 P=0.194N        | 
|COCH-ARM / FISHERS |                  P=0.373                  P=0.029N*                P=0.259N                 P=0.413N        | 
|ORDER RESTRICTED   |                  P=0.057N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 10      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  42/53 (79%)              36/55 (65%)              38/53 (72%)              39/53 (74%)     | 
|POLY-3 RATE (b)    |                  42/46.17                 36/46.12                 38/48.57                 39/48.24        | 
|POLY-3 PERCENT (g) |                  91.0%                    78.1%                    78.2%                    80.8%           | 
|TERMINAL (d)       |                  12/15 (80%)              19/25 (76%)              19/26 (73%)              16/22 (73%)     | 
|FIRST INCIDENCE    |                  309                      356                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.138N                 P=0.005N**               P=0.007N**               P=0.054N        | 
|POLY 3             |                  P=0.192N                 P=0.064N                 P=0.064N                 P=0.114N        | 
|POLY 1.5           |                  P=0.212N                 P=0.056N                 P=0.073N                 P=0.122N        | 
|POLY 6             |                  P=0.231N                 P=0.072N                 P=0.075N                 P=0.149N        | 
|LOGISTIC REGRESSION|                  P=0.274N                 P=0.023N*                P=0.104N                 P=0.134N        | 
|COCH-ARM / FISHERS |                  P=0.492N                 P=0.083N                 P=0.249N                 P=0.324N        | 
|ORDER RESTRICTED   |                  P=0.083N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/51 (29%)              18/54 (33%)              20/53 (38%)              16/53 (30%)     | 
|POLY-3 RATE (b)    |                  15/32.57                 18/41.27                 20/43.98                 16/40.27        | 
|POLY-3 PERCENT (g) |                  46.1%                    43.6%                    45.5%                    39.7%           | 
|TERMINAL (d)       |                  9/15 (60%)               8/25 (32%)               10/26 (39%)              8/22 (36%)      | 
|FIRST INCIDENCE    |                  603                      434                      328                      487             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.344N                 P=0.271N                 P=0.362N                 P=0.280N        | 
|POLY 3             |                  P=0.352N                 P=0.511N                 P=0.574N                 P=0.377N        | 
|POLY 1.5           |                  P=0.391N                 P=0.561                  P=0.473                  P=0.447N        | 
|POLY 6             |                  P=0.358N                 P=0.356N                 P=0.424N                 P=0.313N        | 
|LOGISTIC REGRESSION|                  P=0.405N                 P=0.566N                 P=0.483                  P=0.397N        | 
|COCH-ARM / FISHERS |                  P=0.494                  P=0.412                  P=0.245                  P=0.551         | 
|ORDER RESTRICTED   |                  P=0.470N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 11      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/51 (29%)              18/54 (33%)              20/53 (38%)              17/53 (32%)     | 
|POLY-3 RATE (b)    |                  15/32.57                 18/41.27                 20/43.98                 17/40.27        | 
|POLY-3 PERCENT (g) |                  46.1%                    43.6%                    45.5%                    42.2%           | 
|TERMINAL (d)       |                  9/15 (60%)               8/25 (32%)               10/26 (39%)              9/22 (41%)      | 
|FIRST INCIDENCE    |                  603                      434                      328                      487             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.417N                 P=0.271N                 P=0.362N                 P=0.340N        | 
|POLY 3             |                  P=0.443N                 P=0.511N                 P=0.574N                 P=0.463N        | 
|POLY 1.5           |                  P=0.480N                 P=0.561                  P=0.473                  P=0.532N        | 
|POLY 6             |                  P=0.453N                 P=0.356N                 P=0.424N                 P=0.398N        | 
|LOGISTIC REGRESSION|                  P=0.489N                 P=0.566N                 P=0.483                  P=0.478N        | 
|COCH-ARM / FISHERS |                  P=0.410                  P=0.412                  P=0.245                  P=0.468         | 
|ORDER RESTRICTED   |                  P=0.585N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Intermedia                                                                                                 | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  1/51 (2%)                2/54 (4%)                1/53 (2%)                0/53 (0%)       | 
|POLY-3 RATE (b)    |                  1/31.44                  2/37.71                  1/40.51                  0/37.32         | 
|POLY-3 PERCENT (g) |                  3.2%                     5.3%                     2.5%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                2/25 (8%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  554                      727 (T)                  328                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.171N                 P=0.635                  P=0.727N                 P=0.463N        | 
|POLY 3             |                  P=0.174N                 P=0.563                  P=0.702N                 P=0.466N        | 
|POLY 1.5           |                  P=0.181N                 P=0.545                  P=0.719N                 P=0.472N        | 
|POLY 6             |                  P=0.172N                 P=0.591                  P=0.682N                 P=0.462N        | 
|LOGISTIC REGRESSION|                  P=0.217N                 P=0.566                  P=0.690                  P=0.515N        | 
|COCH-ARM / FISHERS |                  P=0.206N                 P=0.522                  P=0.743N                 P=0.490N        | 
|ORDER RESTRICTED   |                  P=0.230N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 12      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/52 (29%)              15/55 (27%)              15/52 (29%)              13/51 (25%)     | 
|POLY-3 RATE (b)    |                  15/33.48                 15/41.22                 15/42.66                 13/39.21        | 
|POLY-3 PERCENT (g) |                  44.8%                    36.4%                    35.2%                    33.2%           | 
|TERMINAL (d)       |                  8/15 (53%)               8/25 (32%)               7/26 (27%)               8/22 (36%)      | 
|FIRST INCIDENCE    |                  519                      524                      541                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.172N                 P=0.138N                 P=0.122N                 P=0.124N        | 
|POLY 3             |                  P=0.224N                 P=0.304N                 P=0.265N                 P=0.211N        | 
|POLY 1.5           |                  P=0.260N                 P=0.397N                 P=0.377N                 P=0.273N        | 
|POLY 6             |                  P=0.222N                 P=0.196N                 P=0.160N                 P=0.168N        | 
|LOGISTIC REGRESSION|                  P=0.257N                 P=0.307N                 P=0.295N                 P=0.240N        | 
|COCH-ARM / FISHERS |                  P=0.414N                 P=0.513N                 P=0.586N                 P=0.436N        | 
|ORDER RESTRICTED   |                  P=0.249N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/52 (0%)                1/55 (2%)                2/52 (4%)                0/51 (0%)       | 
|POLY-3 RATE (b)    |                  0/31.37                  1/38.53                  2/39.64                  0/36.51         | 
|POLY-3 PERCENT (g) |                  0.0%                     2.6%                     5.1%                     0.0%            | 
|TERMINAL (d)       |                  0/15 (0%)                1/25 (4%)                1/26 (4%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      727 (T)                  709                      ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.583N                 P=0.602                  P=0.368                  (e)             | 
|POLY 3             |                  P=0.586N                 P=0.541                  P=0.292                  (e)             | 
|POLY 1.5           |                  P=0.602N                 P=0.527                  P=0.272                  (e)             | 
|POLY 6             |                  P=0.576N                 P=0.561                  P=0.318                  (e)             | 
|LOGISTIC REGRESSION|                  P=0.599N                 P=0.602                  P=0.341                  (e)             | 
|COCH-ARM / FISHERS |                  P=0.612                  P=0.514                  P=0.248                  (e)             | 
|ORDER RESTRICTED   |                  P=0.356N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 13      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  15/52 (29%)              16/55 (29%)              17/52 (33%)              13/51 (25%)     | 
|POLY-3 RATE (b)    |                  15/33.48                 16/41.22                 17/42.73                 13/39.21        | 
|POLY-3 PERCENT (g) |                  44.8%                    38.8%                    39.8%                    33.2%           | 
|TERMINAL (d)       |                  8/15 (53%)               9/25 (36%)               8/26 (31%)               8/22 (36%)      | 
|FIRST INCIDENCE    |                  519                      524                      541                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.168N                 P=0.176N                 P=0.200N                 P=0.124N        | 
|POLY 3             |                  P=0.214N                 P=0.385N                 P=0.417N                 P=0.211N        | 
|POLY 1.5           |                  P=0.253N                 P=0.482N                 P=0.543N                 P=0.273N        | 
|POLY 6             |                  P=0.211N                 P=0.261N                 P=0.278N                 P=0.168N        | 
|LOGISTIC REGRESSION|                  P=0.250N                 P=0.378N                 P=0.436N                 P=0.240N        | 
|COCH-ARM / FISHERS |                  P=0.419N                 P=0.574                  P=0.416                  P=0.436N        | 
|ORDER RESTRICTED   |                  P=0.252N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                3/55 (5%)                1/53 (2%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  3/38.64                  1/39.86                  1/37.32         | 
|POLY-3 PERCENT (g) |                  0.0%                     7.8%                     2.5%                     2.7%            | 
|TERMINAL (d)       |                  0/15 (0%)                2/25 (8%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      700                      659                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.497N                 P=0.228                  P=0.568                  P=0.576         | 
|POLY 3             |                  P=0.475N                 P=0.159                  P=0.547                  P=0.534         | 
|POLY 1.5           |                  P=0.502N                 P=0.144                  P=0.531                  P=0.525         | 
|POLY 6             |                  P=0.451N                 P=0.183                  P=0.567                  P=0.543         | 
|LOGISTIC REGRESSION|                  P=0.512N                 P=0.206                  P=0.535                  P=0.576         | 
|COCH-ARM / FISHERS |                  P=0.562N                 P=0.129                  P=0.500                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.274                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 14      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                5/55 (9%)                7/53 (13%)               3/53 (6%)       | 
|POLY-3 RATE (b)    |                  4/31.79                  5/39.02                  7/40.14                  3/37.58         | 
|POLY-3 PERCENT (g) |                  12.6%                    12.8%                    17.4%                    8.0%            | 
|TERMINAL (d)       |                  2/15 (13%)               2/25 (8%)                4/26 (15%)               2/22 (9%)       | 
|FIRST INCIDENCE    |                  660                      630                      652                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.326N                 P=0.479N                 P=0.591                  P=0.328N        | 
|POLY 3             |                  P=0.363N                 P=0.628                  P=0.407                  P=0.408N        | 
|POLY 1.5           |                  P=0.379N                 P=0.584                  P=0.353                  P=0.432N        | 
|POLY 6             |                  P=0.369N                 P=0.591N                 P=0.474                  P=0.387N        | 
|LOGISTIC REGRESSION|                  P=0.355N                 P=0.585N                 P=0.497                  P=0.369N        | 
|COCH-ARM / FISHERS |                  P=0.460N                 P=0.524                  P=0.263                  P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.350N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                0/55 (0%)                0/53 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  0/38.53                  0/39.60                  2/37.58         | 
|POLY-3 PERCENT (g) |                  0.0%                     0.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  ---                      ---                      ---                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.055                  (e)                      (e)                      P=0.322         | 
|POLY 3             |                  P=0.049 *                (e)                      (e)                      P=0.279         | 
|POLY 1.5           |                  P=0.048 *                (e)                      (e)                      P=0.267         | 
|POLY 6             |                  P=0.049 *                (e)                      (e)                      P=0.291         | 
|LOGISTIC REGRESSION|                  P=0.049 *                (e)                      (e)                      P=0.285         | 
|COCH-ARM / FISHERS |                  P=0.045 *                (e)                      (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.047 *                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 15      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  4/53 (8%)                5/55 (9%)                7/53 (13%)               5/53 (9%)       | 
|POLY-3 RATE (b)    |                  4/31.79                  5/39.02                  7/40.14                  5/37.84         | 
|POLY-3 PERCENT (g) |                  12.6%                    12.8%                    17.4%                    13.2%           | 
|TERMINAL (d)       |                  2/15 (13%)               2/25 (8%)                4/26 (15%)               3/22 (14%)      | 
|FIRST INCIDENCE    |                  660                      630                      652                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.518                  P=0.479N                 P=0.591                  P=0.571N        | 
|POLY 3             |                  P=0.476                  P=0.628                  P=0.407                  P=0.610         | 
|POLY 1.5           |                  P=0.458                  P=0.584                  P=0.353                  P=0.580         | 
|POLY 6             |                  P=0.476                  P=0.591N                 P=0.474                  P=0.638         | 
|LOGISTIC REGRESSION|                  P=0.476                  P=0.585N                 P=0.497                  P=0.636N        | 
|COCH-ARM / FISHERS |                  P=0.373                  P=0.524                  P=0.263                  P=0.500         | 
|ORDER RESTRICTED   |                  P=0.584                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Hemangiosarcoma                                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/53 (4%)                0/55 (0%)                0/53 (0%)                1/53 (2%)       | 
|POLY-3 RATE (b)    |                  2/31.60                  0/38.53                  0/39.60                  1/37.32         | 
|POLY-3 PERCENT (g) |                  6.3%                     0.0%                     0.0%                     2.7%            | 
|TERMINAL (d)       |                  1/15 (7%)                0/25 (0%)                0/26 (0%)                1/22 (5%)       | 
|FIRST INCIDENCE    |                  671                      ---                      ---                      727 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.399N                 P=0.139N                 P=0.138N                 P=0.390N        | 
|POLY 3             |                  P=0.465N                 P=0.195N                 P=0.190N                 P=0.442N        | 
|POLY 1.5           |                  P=0.455N                 P=0.208N                 P=0.206N                 P=0.457N        | 
|POLY 6             |                  P=0.486N                 P=0.177N                 P=0.174N                 P=0.429N        | 
|LOGISTIC REGRESSION|                  P=0.407N                 P=0.168N                 P=0.164N                 P=0.409N        | 
|COCH-ARM / FISHERS |                  P=0.449N                 P=0.238N                 P=0.248N                 P=0.500N        | 
|ORDER RESTRICTED   |                  P=0.093N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 16      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/53 (0%)                2/55 (4%)                0/53 (0%)                2/53 (4%)       | 
|POLY-3 RATE (b)    |                  0/31.38                  2/40.04                  0/39.60                  2/37.84         | 
|POLY-3 PERCENT (g) |                  0.0%                     5.0%                     0.0%                     5.3%            | 
|TERMINAL (d)       |                  0/15 (0%)                0/25 (0%)                0/26 (0%)                0/22 (0%)       | 
|FIRST INCIDENCE    |                  ---                      82                       ---                      658             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.347                  P=0.265                  (e)                      P=0.316         | 
|POLY 3             |                  P=0.368                  P=0.294                  (e)                      P=0.280         | 
|POLY 1.5           |                  P=0.348                  P=0.275                  (e)                      P=0.268         | 
|POLY 6             |                  P=0.392                  P=0.324                  (e)                      P=0.295         | 
|LOGISTIC REGRESSION|                  P=0.219                  P=0.195                  (e)                      P=0.269         | 
|COCH-ARM / FISHERS |                  P=0.302                  P=0.257                  (e)                      P=0.248         | 
|ORDER RESTRICTED   |                  P=0.150                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  45/53 (85%)              45/55 (82%)              48/53 (91%)              45/53 (85%)     | 
|POLY-3 RATE (b)    |                  45/45.97                 45/47.51                 48/51.17                 45/48.55        | 
|POLY-3 PERCENT (g) |                  97.9%                    94.7%                    93.8%                    92.7%           | 
|TERMINAL (d)       |                  15/15 (100%)             24/25 (96%)              23/26 (89%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  309                      356                      188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.156N                 P=0.016N*                P=0.032N*                P=0.068N        | 
|POLY 3             |                  P=0.162N                 P=0.377N                 P=0.296N                 P=0.180N        | 
|POLY 1.5           |                  P=0.220N                 P=0.381N                 P=0.480N                 P=0.234N        | 
|POLY 6             |                  P=0.239N                 P=0.336N                 P=0.201N                 P=0.260N        | 
|LOGISTIC REGRESSION|                  P=0.211N                 P=0.158N                 P=0.613N                 P=0.117N        | 
|COCH-ARM / FISHERS |                  P=0.373                  P=0.432N                 P=0.278                  P=0.607N        | 
|ORDER RESTRICTED   |                  P=0.156N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/01/03                           EXPERIMENT: 96007 TEST: 01                                            Page 17      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  13/53 (25%)              19/55 (35%)              18/53 (34%)              15/53 (28%)     | 
|POLY-3 RATE (b)    |                  13/35.14                 19/45.38                 18/44.03                 15/40.97        | 
|POLY-3 PERCENT (g) |                  37.0%                    41.9%                    40.9%                    36.6%           | 
|TERMINAL (d)       |                  5/15 (33%)               6/25 (24%)               8/26 (31%)               8/22 (36%)      | 
|FIRST INCIDENCE    |                  176                      82                       236                      448             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.352N                 P=0.555                  P=0.483N                 P=0.425N        | 
|POLY 3             |                  P=0.442N                 P=0.414                  P=0.451                  P=0.583N        | 
|POLY 1.5           |                  P=0.481N                 P=0.312                  P=0.343                  P=0.543         | 
|POLY 6             |                  P=0.429N                 P=0.561                  P=0.592                  P=0.520N        | 
|LOGISTIC REGRESSION|                  P=0.478                  P=0.162                  P=0.244                  P=0.500         | 
|COCH-ARM / FISHERS |                  P=0.474                  P=0.177                  P=0.197                  P=0.413         | 
|ORDER RESTRICTED   |                  P=0.592N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG/KG                  30 NG/KG                 100                      175             | 
|                   |                                                                    NG/KG                    NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  49/53 (92%)              51/55 (93%)              51/53 (96%)              47/53 (89%)     | 
|POLY-3 RATE (b)    |                  49/49.21                 51/52.35                 51/52.14                 47/49.77        | 
|POLY-3 PERCENT (g) |                  99.6%                    97.4%                    97.8%                    94.4%           | 
|TERMINAL (d)       |                  15/15 (100%)             24/25 (96%)              25/26 (96%)              21/22 (96%)     | 
|FIRST INCIDENCE    |                  176                      82                       188                      385             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.073N                 P=0.036N*                P=0.021N*                P=0.043N*       | 
|POLY 3             |                  P=0.081N                 P=0.466N                 P=0.543N                 P=0.125N        | 
|POLY 1.5           |                  P=0.092N                 P=0.452N                 P=0.654N                 P=0.134N        | 
|POLY 6             |                  P=0.160N                 P=0.507N                 P=0.515N                 P=0.229N        | 
|LOGISTIC REGRESSION|                  P=0.089N                 P=0.547N                 P=0.661                  P=0.066N        | 
|COCH-ARM / FISHERS |                  P=0.323N                 P=0.621                  P=0.339                  P=0.371N        | 
|ORDER RESTRICTED   |                  P=0.047N*                (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
                                                                                                                                   
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).