Share This:
https://ntp.niehs.nih.gov/go/5925

TDMS Study 96007-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:35:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                FINAL #3/CONTROL VS. TREATED GROUPS                                                 
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 002    6 NG/KG                                                                       
                                       INCLUDE 003    20 NG/KG                                                                      
                                       INCLUDE 004    44 NG/KG                                                                      
                                       INCLUDE 005    92 NG/KG                                                                      
                                       INCLUDE 006    200     NG/KG                                                                 
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:35:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
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                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:35:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION(                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Liver                                  Cholangiocarcinoma                                                                           
                                       Hepatocellular Adenoma                                                                       
Mammary Gland                          Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Thyroid Gland: C-Cell                  Carcinoma or Adenoma                                                                         
Uterus                                 Adenoma                                                                                      
All Organs                             Malignant Tumors                                                                             
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        0/52 (0%)        2/53 (4%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        1/41.78          1/38.07          0/36.67          0/37.91          2/36.31          0/36.61         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             0.0%             0.0%             5.5%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        1/20 (5%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        728 (T)          728 (T)          ---              ---              681              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.525N         P=0.734          P=0.508N         P=0.500N         P=0.432          P=0.517N        | 
|POLY 3             |        P=0.522N         P=0.740          P=0.526N         P=0.519N         P=0.451          P=0.526N        | 
|POLY 1.5           |        P=0.514N         P=0.748          P=0.520N         P=0.512N         P=0.464          P=0.517N        | 
|POLY 6             |        P=0.529N         P=0.731          P=0.531N         P=0.528N         P=0.445          P=0.535N        | 
|LOGISTIC REGRESSION|        P=0.535N         P=0.734          (e)              (e)              P=0.441          (e)             | 
|COCH-ARM / FISHERS |        P=0.507N         P=0.752N         P=0.500N         P=0.505N         P=0.500          P=0.500N        | 
|ORDER RESTRICTED   |        P=0.356N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        5/53 (9%)        2/53 (4%)        6/52 (12%)       1/53 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        4/42.04          5/38.67          2/36.78          6/37.91          1/36.13          2/36.98         | 
|POLY-3 PERCENT (g) |        9.5%             12.9%            5.4%             15.8%            2.8%             5.4%            | 
|TERMINAL (d)       |        3/25 (12%)       2/22 (9%)        1/24 (4%)        6/25 (24%)       1/20 (5%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        659              651              701              728 (T)          728 (T)          624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.167N         P=0.405          P=0.377N         P=0.352          P=0.244N         P=0.399N        | 
|POLY 3             |        P=0.164N         P=0.447          P=0.400N         P=0.304          P=0.227N         P=0.397N        | 
|POLY 1.5           |        P=0.154N         P=0.468          P=0.384N         P=0.330          P=0.213N         P=0.375N        | 
|POLY 6             |        P=0.173N         P=0.428          P=0.412N         P=0.274          P=0.236N         P=0.418N        | 
|LOGISTIC REGRESSION|        P=0.171N         P=0.420          P=0.411N         P=0.276          P=0.231N         P=0.411N        | 
|COCH-ARM / FISHERS |        P=0.138N         P=0.500          P=0.339N         P=0.359          P=0.181N         P=0.339N        | 
|ORDER RESTRICTED   |        P=0.226N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        5/53 (9%)        3/53 (6%)        6/52 (12%)       1/53 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        5/42.04          5/38.67          3/36.78          6/37.91          1/36.13          2/36.98         | 
|POLY-3 PERCENT (g) |        11.9%            12.9%            8.2%             15.8%            2.8%             5.4%            | 
|TERMINAL (d)       |        4/25 (16%)       2/22 (9%)        2/24 (8%)        6/25 (24%)       1/20 (5%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        659              651              701              728 (T)          728 (T)          624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.108N         P=0.531          P=0.396N         P=0.486          P=0.154N         P=0.270N        | 
|POLY 3             |        P=0.105N         P=0.578          P=0.431N         P=0.427          P=0.139N         P=0.270N        | 
|POLY 1.5           |        P=0.098N         P=0.598          P=0.412N         P=0.456          P=0.128N         P=0.250N        | 
|POLY 6             |        P=0.111N         P=0.558          P=0.446N         P=0.392          P=0.146N         P=0.288N        | 
|LOGISTIC REGRESSION|        P=0.110N         P=0.546          P=0.447N         P=0.397          P=0.143N         P=0.287N        | 
|COCH-ARM / FISHERS |        P=0.087N         P=0.629N         P=0.358N         P=0.486          P=0.103N         P=0.219N        | 
|ORDER RESTRICTED   |        P=0.175N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        0/52 (0%)        2/53 (4%)        0/53 (0%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        1/41.78          2/38.22          0/36.03          2/39.15          0/36.13          0/36.44         | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             0.0%             5.1%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        1/25 (4%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        728 (T)          689              ---              302              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.179N         P=0.454          P=0.508N         P=0.502          P=0.545N         P=0.517N        | 
|POLY 3             |        P=0.185N         P=0.469          P=0.529N         P=0.477          P=0.529N         P=0.527N        | 
|POLY 1.5           |        P=0.179N         P=0.481          P=0.523N         P=0.489          P=0.521N         P=0.519N        | 
|POLY 6             |        P=0.190N         P=0.456          P=0.533N         P=0.463          P=0.533N         P=0.535N        | 
|LOGISTIC REGRESSION|        P=0.173N         P=0.443          (e)              P=0.518          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.171N         P=0.500          P=0.505N         P=0.500          P=0.500N         P=0.505N        | 
|ORDER RESTRICTED   |        P=0.220N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        1/53 (2%)        1/52 (2%)        1/52 (2%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          1/36.67          1/37.91          1/35.47          2/36.44         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             2.7%             2.6%             2.8%             5.5%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        1/25 (4%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        ---              ---              728 (T)          728 (T)          721              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.087          (e)              P=0.492          P=0.500          P=0.476          P=0.219         | 
|POLY 3             |        P=0.082          (e)              P=0.474          P=0.481          P=0.467          P=0.207         | 
|POLY 1.5           |        P=0.086          (e)              P=0.480          P=0.488          P=0.475          P=0.217         | 
|POLY 6             |        P=0.078          (e)              P=0.469          P=0.472          P=0.464          P=0.199         | 
|LOGISTIC REGRESSION|        P=0.086          (e)              P=0.492          P=0.500          P=0.464          P=0.219         | 
|COCH-ARM / FISHERS |        P=0.094          (e)              P=0.500          P=0.495          P=0.495          P=0.243         | 
|ORDER RESTRICTED   |        P=0.075          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/53 (4%)        1/52 (2%)        1/52 (2%)        2/52 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          2/36.67          1/37.91          1/35.47          2/36.44         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             5.5%             2.6%             2.8%             5.5%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        2/24 (8%)        1/25 (4%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        ---              ---              728 (T)          728 (T)          721              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.156          (e)              P=0.228          P=0.500          P=0.476          P=0.219         | 
|POLY 3             |        P=0.143          (e)              P=0.209          P=0.481          P=0.467          P=0.207         | 
|POLY 1.5           |        P=0.151          (e)              P=0.216          P=0.488          P=0.475          P=0.217         | 
|POLY 6             |        P=0.137          (e)              P=0.204          P=0.472          P=0.464          P=0.199         | 
|LOGISTIC REGRESSION|        P=0.154          (e)              P=0.228          P=0.500          P=0.464          P=0.219         | 
|COCH-ARM / FISHERS |        P=0.166          (e)              P=0.248          P=0.495          P=0.495          P=0.243         | 
|ORDER RESTRICTED   |        P=0.101          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiocarcinoma                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        1/53 (2%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          1/37.91          1/36.13          2/37.02         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             2.6%             2.8%             5.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        1/25 (4%)        1/20 (5%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              728 (T)          728 (T)          608             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.034 *        (e)              (e)              P=0.500          P=0.455          P=0.201         | 
|POLY 3             |        P=0.036 *        (e)              (e)              P=0.481          P=0.471          P=0.211         | 
|POLY 1.5           |        P=0.038 *        (e)              (e)              P=0.488          P=0.479          P=0.220         | 
|POLY 6             |        P=0.035 *        (e)              (e)              P=0.472          P=0.467          P=0.203         | 
|LOGISTIC REGRESSION|        P=0.034 *        (e)              (e)              P=0.500          P=0.455          P=0.219         | 
|COCH-ARM / FISHERS |        P=0.041 *        (e)              (e)              P=0.495          P=0.500          P=0.248         | 
|ORDER RESTRICTED   |        P=0.047 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/53 (0%)        1/53 (2%)        0/52 (0%)        2/53 (4%)        4/53 (8%)       | 
|POLY-3 RATE (b)    |        1/41.97          0/38.07          1/36.67          0/37.91          2/36.13          4/36.76         | 
|POLY-3 PERCENT (g) |        2.4%             0.0%             2.7%             0.0%             5.5%             10.9%           | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        0/25 (0%)        2/20 (10%)       3/23 (13%)      | 
|FIRST INCIDENCE    |        678              ---              728 (T)          ---              728 (T)          689             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.007 **       P=0.546N         P=0.726          P=0.554N         P=0.417          P=0.149         | 
|POLY 3             |        P=0.006 **       P=0.519N         P=0.730          P=0.520N         P=0.448          P=0.140         | 
|POLY 1.5           |        P=0.007 **       P=0.512N         P=0.738          P=0.512N         P=0.462          P=0.154         | 
|POLY 6             |        P=0.006 **       P=0.528N         P=0.724          P=0.530N         P=0.439          P=0.127         | 
|LOGISTIC REGRESSION|        P=0.005 **       P=0.514N         P=0.730          P=0.515N         P=0.441          P=0.127         | 
|COCH-ARM / FISHERS |        P=0.008 **       P=0.500N         P=0.752N         P=0.505N         P=0.500          P=0.181         | 
|ORDER RESTRICTED   |        P=0.011 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        2/53 (4%)        0/53 (0%)        1/53 (2%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        1/41.78          1/38.07          2/36.67          0/38.22          1/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             5.5%             0.0%             2.8%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        2/24 (8%)        0/25 (0%)        1/20 (5%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        728 (T)          728 (T)          728 (T)          ---              728 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.254N         P=0.734          P=0.486          P=0.500N         P=0.712          P=0.517N        | 
|POLY 3             |        P=0.261N         P=0.740          P=0.455          P=0.518N         P=0.728          P=0.526N        | 
|POLY 1.5           |        P=0.255N         P=0.748          P=0.466          P=0.509N         P=0.737          P=0.517N        | 
|POLY 6             |        P=0.266N         P=0.731          P=0.446          P=0.527N         P=0.723          P=0.535N        | 
|LOGISTIC REGRESSION|        P=0.254N         P=0.734          P=0.486          (e)              P=0.712          (e)             | 
|COCH-ARM / FISHERS |        P=0.239N         P=0.752N         P=0.500          P=0.500N         P=0.752N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.263N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/53 (9%)        12/53 (23%)      13/53 (25%)      2/53 (4%)        5/53 (9%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        5/42.44          12/40.22         13/40.44         2/38.22          5/37.02          3/38.06         | 
|POLY-3 PERCENT (g) |        11.8%            29.8%            32.2%            5.2%             13.5%            7.9%            | 
|TERMINAL (d)       |        3/25 (12%)       6/22 (27%)       7/24 (29%)       2/25 (8%)        4/20 (20%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        619              420              219              728 (T)          348              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.026N*        P=0.034 *        P=0.028 *        P=0.247N         P=0.505          P=0.430N        | 
|POLY 3             |        P=0.021N*        P=0.036 *        P=0.021 *        P=0.259N         P=0.543          P=0.417N        | 
|POLY 1.5           |        P=0.019N*        P=0.042 *        P=0.024 *        P=0.238N         P=0.568          P=0.395N        | 
|POLY 6             |        P=0.024N*        P=0.030 *        P=0.018 *        P=0.286N         P=0.524          P=0.440N        | 
|LOGISTIC REGRESSION|        P=0.018N*        P=0.040 *        P=0.035 *        P=0.267N         P=0.567          P=0.362N        | 
|COCH-ARM / FISHERS |        P=0.016N*        P=0.055          P=0.034 *        P=0.219N         P=0.629N         P=0.358N        | 
|ORDER RESTRICTED   |        P=0.028N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/53 (11%)       13/53 (25%)      14/53 (26%)      2/53 (4%)        6/53 (11%)       3/53 (6%)       | 
|POLY-3 RATE (b)    |        6/42.44          13/40.22         14/40.44         2/38.22          6/37.02          3/38.06         | 
|POLY-3 PERCENT (g) |        14.1%            32.3%            34.6%            5.2%             16.2%            7.9%            | 
|TERMINAL (d)       |        4/25 (16%)       7/22 (32%)       8/24 (33%)       2/25 (8%)        5/20 (25%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        619              420              219              728 (T)          348              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.016N*        P=0.037 *        P=0.031 *        P=0.155N         P=0.477          P=0.310N        | 
|POLY 3             |        P=0.012N*        P=0.040 *        P=0.024 *        P=0.167N         P=0.522          P=0.297N        | 
|POLY 1.5           |        P=0.011N*        P=0.048 *        P=0.027 *        P=0.150N         P=0.551          P=0.276N        | 
|POLY 6             |        P=0.014N*        P=0.034 *        P=0.021 *        P=0.190N         P=0.501          P=0.318N        | 
|LOGISTIC REGRESSION|        P=0.011N*        P=0.042 *        P=0.037 *        P=0.177N         P=0.535          P=0.258N        | 
|COCH-ARM / FISHERS |        P=0.010N*        P=0.064          P=0.040 *        P=0.135N         P=0.620N         P=0.244N        | 
|ORDER RESTRICTED   |        P=0.014N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      35/53 (66%)      30/53 (57%)      29/53 (55%)      34/53 (64%)      30/53 (57%)     | 
|POLY-3 RATE (b)    |        34/49.74         35/46.94         30/42.83         29/46.77         34/45.32         30/43.49        | 
|POLY-3 PERCENT (g) |        68.4%            74.6%            70.0%            62.0%            75.0%            69.0%           | 
|TERMINAL (d)       |        14/25 (56%)      13/22 (59%)      15/24 (63%)      11/25 (44%)      13/20 (65%)      15/23 (65%)     | 
|FIRST INCIDENCE    |        289              289              393              302              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.513          P=0.263          P=0.530N         P=0.428N         P=0.226          P=0.549         | 
|POLY 3             |        P=0.536          P=0.321          P=0.521          P=0.325N         P=0.307          P=0.565         | 
|POLY 1.5           |        P=0.447N         P=0.387          P=0.565N         P=0.271N         P=0.367          P=0.490N        | 
|POLY 6             |        P=0.436          P=0.277          P=0.467          P=0.383N         P=0.283          P=0.448         | 
|LOGISTIC REGRESSION|        P=0.366N         P=0.487          P=0.406N         P=0.199N         P=0.503          P=0.348N        | 
|COCH-ARM / FISHERS |        P=0.301N         P=0.500          P=0.276N         P=0.214N         P=0.580N         P=0.276N        | 
|ORDER RESTRICTED   |        P=0.616          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        35/53 (66%)      36/53 (68%)      30/53 (57%)      29/53 (55%)      35/53 (66%)      30/53 (57%)     | 
|POLY-3 RATE (b)    |        35/49.74         36/46.94         30/42.83         29/46.77         35/45.32         30/43.49        | 
|POLY-3 PERCENT (g) |        70.4%            76.7%            70.0%            62.0%            77.2%            69.0%           | 
|TERMINAL (d)       |        15/25 (60%)      14/22 (64%)      15/24 (63%)      11/25 (44%)      14/20 (70%)      15/23 (65%)     | 
|FIRST INCIDENCE    |        289              289              393              302              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.502N         P=0.257          P=0.473N         P=0.374N         P=0.215          P=0.512N        | 
|POLY 3             |        P=0.482N         P=0.312          P=0.579N         P=0.251N         P=0.294          P=0.533N        | 
|POLY 1.5           |        P=0.386N         P=0.381          P=0.482N         P=0.204N         P=0.357          P=0.406N        | 
|POLY 6             |        P=0.500          P=0.265          P=0.555          P=0.302N         P=0.268          P=0.537         | 
|LOGISTIC REGRESSION|        P=0.319N         P=0.475          P=0.336N         P=0.151N         P=0.482          P=0.282N        | 
|COCH-ARM / FISHERS |        P=0.254N         P=0.500          P=0.213N         P=0.160N         P=0.581N         P=0.213N        | 
|ORDER RESTRICTED   |        P=0.561N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        38/53 (72%)      40/53 (75%)      37/53 (70%)      31/53 (58%)      38/53 (72%)      31/53 (58%)     | 
|POLY-3 RATE (b)    |        38/50.41         40/48.33         37/46.22         31/46.77         38/46.22         31/44.27        | 
|POLY-3 PERCENT (g) |        75.4%            82.8%            80.1%            66.3%            82.2%            70.0%           | 
|TERMINAL (d)       |        16/25 (64%)      16/22 (73%)      18/24 (75%)      13/25 (52%)      16/20 (80%)      15/23 (65%)     | 
|FIRST INCIDENCE    |        289              289              219              302              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300N         P=0.205          P=0.393          P=0.337N         P=0.199          P=0.417N        | 
|POLY 3             |        P=0.209N         P=0.249          P=0.376          P=0.215N         P=0.278          P=0.357N        | 
|POLY 1.5           |        P=0.138N         P=0.310          P=0.453          P=0.157N         P=0.352          P=0.244N        | 
|POLY 6             |        P=0.314N         P=0.201          P=0.316          P=0.293N         P=0.229          P=0.495N        | 
|LOGISTIC REGRESSION|        P=0.086N         P=0.392          P=0.581          P=0.110N         P=0.477          P=0.152N        | 
|COCH-ARM / FISHERS |        P=0.065N         P=0.413          P=0.500N         P=0.111N         P=0.585N         P=0.111N        | 
|ORDER RESTRICTED   |        P=0.228N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/41.78          2/38.16          1/37.31          0/38.22          1/36.17          3/36.83         | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             2.7%             0.0%             2.8%             8.1%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        728 (T)          706              517              ---              717              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.150          P=0.448          P=0.746          P=0.500N         P=0.722          P=0.264         | 
|POLY 3             |        P=0.149          P=0.468          P=0.735          P=0.518N         P=0.728          P=0.261         | 
|POLY 1.5           |        P=0.155          P=0.481          P=0.741          P=0.509N         P=0.737          P=0.277         | 
|POLY 6             |        P=0.143          P=0.455          P=0.732          P=0.527N         P=0.724          P=0.247         | 
|LOGISTIC REGRESSION|        P=0.145          P=0.437          P=0.762N         (e)              P=0.725          P=0.240         | 
|COCH-ARM / FISHERS |        P=0.167          P=0.500          P=0.752N         P=0.500N         P=0.752N         P=0.309         | 
|ORDER RESTRICTED   |        P=0.134          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/41.78          2/38.16          1/37.31          0/38.22          1/36.17          3/36.83         | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             2.7%             0.0%             2.8%             8.1%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        728 (T)          706              517              ---              717              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.150          P=0.448          P=0.746          P=0.500N         P=0.722          P=0.264         | 
|POLY 3             |        P=0.149          P=0.468          P=0.735          P=0.518N         P=0.728          P=0.261         | 
|POLY 1.5           |        P=0.155          P=0.481          P=0.741          P=0.509N         P=0.737          P=0.277         | 
|POLY 6             |        P=0.143          P=0.455          P=0.732          P=0.527N         P=0.724          P=0.247         | 
|LOGISTIC REGRESSION|        P=0.145          P=0.437          P=0.762N         (e)              P=0.725          P=0.240         | 
|COCH-ARM / FISHERS |        P=0.167          P=0.500          P=0.752N         P=0.500N         P=0.752N         P=0.309         | 
|ORDER RESTRICTED   |        P=0.134          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        3/53 (6%)       | 
|POLY-3 RATE (b)    |        1/41.78          2/38.16          1/37.31          0/38.22          1/36.17          3/36.83         | 
|POLY-3 PERCENT (g) |        2.4%             5.2%             2.7%             0.0%             2.8%             8.1%            | 
|TERMINAL (d)       |        1/25 (4%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        2/23 (9%)       | 
|FIRST INCIDENCE    |        728 (T)          706              517              ---              717              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.150          P=0.448          P=0.746          P=0.500N         P=0.722          P=0.264         | 
|POLY 3             |        P=0.149          P=0.468          P=0.735          P=0.518N         P=0.728          P=0.261         | 
|POLY 1.5           |        P=0.155          P=0.481          P=0.741          P=0.509N         P=0.737          P=0.277         | 
|POLY 6             |        P=0.143          P=0.455          P=0.732          P=0.527N         P=0.724          P=0.247         | 
|LOGISTIC REGRESSION|        P=0.145          P=0.437          P=0.762N         (e)              P=0.725          P=0.240         | 
|COCH-ARM / FISHERS |        P=0.167          P=0.500          P=0.752N         P=0.500N         P=0.752N         P=0.309         | 
|ORDER RESTRICTED   |        P=0.134          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Granulosa Cell Tumor: Benign, Malignant, NOS                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/53 (4%)        1/53 (2%)        0/52 (0%)        0/52 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          2/38.36          1/36.67          0/37.91          0/35.44          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             5.2%             2.7%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        1/24 (4%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              651              728 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.230N         P=0.208          P=0.492          (e)              (e)              (e)             | 
|POLY 3             |        P=0.238N         P=0.218          P=0.474          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.231N         P=0.226          P=0.480          (e)              (e)              (e)             | 
|POLY 6             |        P=0.243N         P=0.211          P=0.469          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.229N         P=0.216          P=0.492          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.215N         P=0.248          P=0.500          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.279N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/52 (0%)        2/52 (4%)        0/52 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          0/38.07          0/36.67          0/37.91          2/35.44          0/36.44         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.6%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        2/20 (10%)       0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              728 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.448          (e)              (e)              (e)              P=0.190          (e)             | 
|POLY 3             |        P=0.442          (e)              (e)              (e)              P=0.202          (e)             | 
|POLY 1.5           |        P=0.452          (e)              (e)              (e)              P=0.210          (e)             | 
|POLY 6             |        P=0.426          (e)              (e)              (e)              P=0.198          (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P=0.190          (e)             | 
|COCH-ARM / FISHERS |        P=0.458          (e)              (e)              (e)              P=0.243          (e)             | 
|ORDER RESTRICTED   |        P=0.152          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        2/51 (4%)        0/44 (0%)        0/51 (0%)        0/49 (0%)        0/49 (0%)       | 
|POLY-3 RATE (b)    |        0/38.63          2/37.50          0/31.58          0/37.26          0/34.13          0/33.79         | 
|POLY-3 PERCENT (g) |        0.0%             5.3%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/21 (5%)        0/22 (0%)        0/25 (0%)        0/19 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              503              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.300N         P=0.218          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.299N         P=0.230          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.293N         P=0.237          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.306N         P=0.222          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.284N         P=0.254          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.287N         P=0.258          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.209N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      21/53 (40%)      23/53 (43%)      23/53 (43%)      21/53 (40%)      16/53 (30%)     | 
|POLY-3 RATE (b)    |        15/43.22         21/40.29         23/40.24         23/41.13         21/40.54         16/39.31        | 
|POLY-3 PERCENT (g) |        34.7%            52.1%            57.2%            55.9%            51.8%            40.7%           | 
|TERMINAL (d)       |        8/25 (32%)       12/22 (55%)      13/24 (54%)      16/25 (64%)      8/20 (40%)       8/23 (35%)      | 
|FIRST INCIDENCE    |        603              600              420              470              420              549             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.420N         P=0.070          P=0.046 *        P=0.052          P=0.061          P=0.332         | 
|POLY 3             |        P=0.344N         P=0.075          P=0.027 *        P=0.034 *        P=0.081          P=0.367         | 
|POLY 1.5           |        P=0.313N         P=0.100          P=0.034 *        P=0.050          P=0.090          P=0.411         | 
|POLY 6             |        P=0.360N         P=0.058          P=0.027 *        P=0.022 *        P=0.089          P=0.335         | 
|LOGISTIC REGRESSION|        P=0.383N         P=0.057          P=0.022 *        P=0.024 *        P=0.064          P=0.317         | 
|COCH-ARM / FISHERS |        P=0.255N         P=0.153          P=0.078          P=0.078          P=0.153          P=0.500         | 
|ORDER RESTRICTED   |        P=0.085          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      22/53 (42%)      23/53 (43%)      23/53 (43%)      21/53 (40%)      16/53 (30%)     | 
|POLY-3 RATE (b)    |        15/43.22         22/40.53         23/40.24         23/41.13         21/40.54         16/39.31        | 
|POLY-3 PERCENT (g) |        34.7%            54.3%            57.2%            55.9%            51.8%            40.7%           | 
|TERMINAL (d)       |        8/25 (32%)       12/22 (55%)      13/24 (54%)      16/25 (64%)      8/20 (40%)       8/23 (35%)      | 
|FIRST INCIDENCE    |        603              600              420              470              420              549             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.390N         P=0.049 *        P=0.046 *        P=0.052          P=0.061          P=0.332         | 
|POLY 3             |        P=0.311N         P=0.050          P=0.027 *        P=0.034 *        P=0.081          P=0.367         | 
|POLY 1.5           |        P=0.281N         P=0.068          P=0.034 *        P=0.050          P=0.090          P=0.411         | 
|POLY 6             |        P=0.329N         P=0.038 *        P=0.027 *        P=0.022 *        P=0.089          P=0.335         | 
|LOGISTIC REGRESSION|        P=0.348N         P=0.037 *        P=0.022 *        P=0.024 *        P=0.064          P=0.317         | 
|COCH-ARM / FISHERS |        P=0.227N         P=0.111          P=0.078          P=0.078          P=0.153          P=0.500         | 
|ORDER RESTRICTED   |        P=0.077          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        2/53 (4%)        1/53 (2%)        0/53 (0%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        0/41.78          1/38.37          2/36.87          1/38.22          0/36.13          2/37.38         | 
|POLY-3 PERCENT (g) |        0.0%             2.6%             5.4%             2.6%             0.0%             5.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        1/24 (4%)        1/25 (4%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        ---              647              675              728 (T)          ---              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.305          P=0.473          P=0.215          P=0.500          (e)              P=0.228         | 
|POLY 3             |        P=0.296          P=0.483          P=0.210          P=0.482          (e)              P=0.213         | 
|POLY 1.5           |        P=0.306          P=0.490          P=0.216          P=0.491          (e)              P=0.221         | 
|POLY 6             |        P=0.288          P=0.476          P=0.206          P=0.473          (e)              P=0.205         | 
|LOGISTIC REGRESSION|        P=0.317          P=0.498          P=0.206          P=0.500          (e)              P=0.259         | 
|COCH-ARM / FISHERS |        P=0.330          P=0.500          P=0.248          P=0.500          (e)              P=0.248         | 
|ORDER RESTRICTED   |        P=0.105          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign,                                                                     | 
|     malignant or NOS)                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        0/41.78          2/38.22          0/36.67          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        0.0%             5.2%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/25 (0%)        1/22 (5%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        ---              689              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.299N         P=0.211          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.304N         P=0.217          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.297N         P=0.225          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.309N         P=0.209          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.303N         P=0.206          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.288N         P=0.248          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.197N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        13/53 (25%)      10/53 (19%)      9/51 (18%)       9/53 (17%)       6/51 (12%)       7/51 (14%)      | 
|POLY-3 RATE (b)    |        13/43.49         10/39.80         9/36.75          9/38.42          6/35.57          7/36.03         | 
|POLY-3 PERCENT (g) |        29.9%            25.1%            24.5%            23.4%            16.9%            19.4%           | 
|TERMINAL (d)       |        8/25 (32%)       5/22 (23%)       6/24 (25%)       8/25 (32%)       4/20 (20%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        500              530              570              675              642              570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.137N         P=0.475N         P=0.316N         P=0.269N         P=0.152N         P=0.178N        | 
|POLY 3             |        P=0.149N         P=0.404N         P=0.386N         P=0.340N         P=0.138N         P=0.207N        | 
|POLY 1.5           |        P=0.133N         P=0.370N         P=0.359N         P=0.288N         P=0.116N         P=0.174N        | 
|POLY 6             |        P=0.163N         P=0.437N         P=0.398N         P=0.406N         P=0.152N         P=0.238N        | 
|LOGISTIC REGRESSION|        P=0.154N         P=0.392N         P=0.369N         P=0.342N         P=0.126N         P=0.197N        | 
|COCH-ARM / FISHERS |        P=0.108N         P=0.319N         P=0.269N         P=0.237N         P=0.076N         P=0.125N        | 
|ORDER RESTRICTED   |        P=0.179N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        2/53 (4%)        2/51 (4%)        2/53 (4%)        0/51 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        2/41.78          2/38.36          2/36.00          2/38.22          0/35.23          1/35.09         | 
|POLY-3 PERCENT (g) |        4.8%             5.2%             5.6%             5.2%             0.0%             2.9%            | 
|TERMINAL (d)       |        2/25 (8%)        1/22 (5%)        1/24 (4%)        2/25 (8%)        0/20 (0%)        1/23 (4%)       | 
|FIRST INCIDENCE    |        728 (T)          651              636              728 (T)          ---              728 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.263N         P=0.644          P=0.665          P=0.697          P=0.288N         P=0.529N        | 
|POLY 3             |        P=0.271N         P=0.664          P=0.640          P=0.662          P=0.276N         P=0.561N        | 
|POLY 1.5           |        P=0.263N         P=0.675          P=0.647          P=0.677          P=0.268N         P=0.544N        | 
|POLY 6             |        P=0.276N         P=0.652          P=0.638          P=0.645          P=0.281N         P=0.575N        | 
|LOGISTIC REGRESSION|        P=0.274N         P=0.644          P=0.634          P=0.697          (e)              P=0.529N        | 
|COCH-ARM / FISHERS |        P=0.245N         P=0.691N         P=0.676          P=0.691N         P=0.257N         P=0.515N        | 
|ORDER RESTRICTED   |        P=0.363N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        15/53 (28%)      12/53 (23%)      10/51 (20%)      10/53 (19%)      6/51 (12%)       7/51 (14%)      | 
|POLY-3 RATE (b)    |        15/43.49         12/40.09         10/36.75         10/38.42         6/35.57          7/36.03         | 
|POLY-3 PERCENT (g) |        34.5%            29.9%            27.2%            26.0%            16.9%            19.4%           | 
|TERMINAL (d)       |        10/25 (40%)      6/22 (27%)       7/24 (29%)       9/25 (36%)       4/20 (20%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        500              530              570              675              642              570             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.052N         P=0.500N         P=0.249N         P=0.201N         P=0.075N         P=0.087N        | 
|POLY 3             |        P=0.055N         P=0.415N         P=0.322N         P=0.275N         P=0.063N         P=0.104N        | 
|POLY 1.5           |        P=0.048N*        P=0.381N         P=0.295N         P=0.226N         P=0.051N         P=0.083N        | 
|POLY 6             |        P=0.062N         P=0.445N         P=0.332N         P=0.341N         P=0.070N         P=0.123N        | 
|LOGISTIC REGRESSION|        P=0.059N         P=0.421N         P=0.313N         P=0.287N         P=0.059N         P=0.105N        | 
|COCH-ARM / FISHERS |        P=0.038N*        P=0.328N         P=0.210N         P=0.180N         P=0.031N*        P=0.056N        | 
|ORDER RESTRICTED   |        P=0.069N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)       | 
|POLY-3 RATE (b)    |        2/41.97          0/38.07          0/36.67          0/38.22          0/36.13          0/36.61         | 
|POLY-3 PERCENT (g) |        4.8%             0.0%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        1/25 (4%)        0/22 (0%)        0/24 (0%)        0/25 (0%)        0/20 (0%)        0/23 (0%)       | 
|FIRST INCIDENCE    |        678              ---              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.262N         P=0.280N         P=0.274N         P=0.269N         P=0.295N         P=0.275N        | 
|POLY 3             |        P=0.225N         P=0.259N         P=0.268N         P=0.258N         P=0.272N         P=0.268N        | 
|POLY 1.5           |        P=0.234N         P=0.250N         P=0.260N         P=0.248N         P=0.262N         P=0.257N        | 
|POLY 6             |        P=0.215N         P=0.270N         P=0.275N         P=0.270N         P=0.278N         P=0.280N        | 
|LOGISTIC REGRESSION|        P=0.261N         P=0.265N         P=0.270N         P=0.265N         P=0.273N         P=0.274N        | 
|COCH-ARM / FISHERS |        P=0.248N         P=0.248N         P=0.248N         P=0.248N         P=0.248N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.013N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        5/53 (9%)        2/53 (4%)       | 
|POLY-3 RATE (b)    |        1/41.97          1/38.16          0/36.67          1/38.22          5/36.27          2/36.98         | 
|POLY-3 PERCENT (g) |        2.4%             2.6%             0.0%             2.6%             13.8%            5.4%            | 
|TERMINAL (d)       |        0/25 (0%)        0/22 (0%)        0/24 (0%)        1/25 (4%)        2/20 (10%)       1/23 (4%)       | 
|FIRST INCIDENCE    |        678              706              ---              728 (T)          707              624             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.107          P=0.713          P=0.554N         P=0.731          P=0.071          P=0.438         | 
|POLY 3             |        P=0.103          P=0.740          P=0.527N         P=0.740          P=0.070          P=0.456         | 
|POLY 1.5           |        P=0.110          P=0.748          P=0.520N         P=0.750          P=0.078          P=0.472         | 
|POLY 6             |        P=0.096          P=0.730          P=0.532N         P=0.728          P=0.065          P=0.441         | 
|LOGISTIC REGRESSION|        P=0.097          P=0.741          P=0.521N         P=0.735          P=0.067          P=0.464         | 
|COCH-ARM / FISHERS |        P=0.121          P=0.752N         P=0.500N         P=0.752N         P=0.103          P=0.500         | 
|ORDER RESTRICTED   |        P=0.062          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/53 (17%)       3/53 (6%)        6/53 (11%)       5/53 (9%)        7/53 (13%)       4/53 (8%)       | 
|POLY-3 RATE (b)    |        9/43.07          3/38.73          6/36.87          5/38.22          7/36.66          4/37.55         | 
|POLY-3 PERCENT (g) |        20.9%            7.8%             16.3%            13.1%            19.1%            10.7%           | 
|TERMINAL (d)       |        4/25 (16%)       1/22 (5%)        5/24 (21%)       5/25 (20%)       3/20 (15%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        588              547              675              728 (T)          667              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.370N         P=0.118N         P=0.376N         P=0.243N         P=0.561N         P=0.196N        | 
|POLY 3             |        P=0.343N         P=0.084N         P=0.405N         P=0.261N         P=0.532N         P=0.172N        | 
|POLY 1.5           |        P=0.329N         P=0.073N         P=0.370N         P=0.227N         P=0.491N         P=0.149N        | 
|POLY 6             |        P=0.354N         P=0.099N         P=0.441N         P=0.311N         P=0.561N         P=0.198N        | 
|LOGISTIC REGRESSION|        P=0.374N         P=0.079N         P=0.395N         P=0.267N         P=0.522N         P=0.158N        | 
|COCH-ARM / FISHERS |        P=0.305N         P=0.061N         P=0.289N         P=0.195N         P=0.393N         P=0.118N        | 
|ORDER RESTRICTED   |        P=0.155N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Sarcoma Stromal or Polyp Stromal                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/53 (17%)       4/53 (8%)        6/53 (11%)       5/53 (9%)        7/53 (13%)       4/53 (8%)       | 
|POLY-3 RATE (b)    |        9/43.07          4/39.40          6/36.87          5/38.22          7/36.66          4/37.55         | 
|POLY-3 PERCENT (g) |        20.9%            10.2%            16.3%            13.1%            19.1%            10.7%           | 
|TERMINAL (d)       |        4/25 (16%)       1/22 (5%)        5/24 (21%)       5/25 (20%)       3/20 (15%)       2/23 (9%)       | 
|FIRST INCIDENCE    |        588              503              675              728 (T)          667              498             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.323N         P=0.199N         P=0.376N         P=0.243N         P=0.561N         P=0.196N        | 
|POLY 3             |        P=0.303N         P=0.149N         P=0.405N         P=0.261N         P=0.532N         P=0.172N        | 
|POLY 1.5           |        P=0.286N         P=0.135N         P=0.370N         P=0.227N         P=0.491N         P=0.149N        | 
|POLY 6             |        P=0.317N         P=0.168N         P=0.441N         P=0.311N         P=0.561N         P=0.198N        | 
|LOGISTIC REGRESSION|        P=0.320N         P=0.135N         P=0.395N         P=0.267N         P=0.522N         P=0.158N        | 
|COCH-ARM / FISHERS |        P=0.260N         P=0.118N         P=0.289N         P=0.195N         P=0.393N         P=0.118N        | 
|ORDER RESTRICTED   |        P=0.161N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        45/53 (85%)      45/53 (85%)      43/53 (81%)      42/53 (79%)      45/53 (85%)      41/53 (77%)     | 
|POLY-3 RATE (b)    |        45/50.55         45/48.80         43/45.62         42/47.71         45/46.75         41/46.25        | 
|POLY-3 PERCENT (g) |        89.0%            92.2%            94.3%            88.0%            96.3%            88.6%           | 
|TERMINAL (d)       |        21/25 (84%)      20/22 (91%)      22/24 (92%)      22/25 (88%)      19/20 (95%)      20/23 (87%)     | 
|FIRST INCIDENCE    |        289              289              393              302              321              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.473          P=0.245          P=0.409          P=0.543          P=0.152          P=0.467         | 
|POLY 3             |        P=0.472N         P=0.414          P=0.278          P=0.571N         P=0.146          P=0.613N        | 
|POLY 1.5           |        P=0.344N         P=0.497          P=0.371          P=0.431N         P=0.229          P=0.457N        | 
|POLY 6             |        P=0.552          P=0.345          P=0.279          P=0.564          P=0.131          P=0.545         | 
|LOGISTIC REGRESSION|        P=0.342N         P=0.513          P=0.455          P=0.366N         P=0.265          P=0.391N        | 
|COCH-ARM / FISHERS |        P=0.215N         P=0.607N         P=0.398N         P=0.307N         P=0.607N         P=0.229N        | 
|ORDER RESTRICTED   |        P=0.450          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            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          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      20/53 (38%)      21/53 (40%)      13/53 (25%)      16/53 (30%)      16/53 (30%)     | 
|POLY-3 RATE (b)    |        12/43.55         20/42.49         21/43.07         13/41.30         16/40.31         16/43.29        | 
|POLY-3 PERCENT (g) |        27.6%            47.1%            48.8%            31.5%            39.7%            37.0%           | 
|TERMINAL (d)       |        7/25 (28%)       8/22 (36%)       10/24 (42%)      8/25 (32%)       6/20 (30%)       5/23 (22%)      | 
|FIRST INCIDENCE    |        377              420              196              302              113              329             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.505          P=0.041 *        P=0.036 *        P=0.445          P=0.136          P=0.178         | 
|POLY 3             |        P=0.454N         P=0.044 *        P=0.030 *        P=0.437          P=0.168          P=0.236         | 
|POLY 1.5           |        P=0.460N         P=0.051          P=0.033 *        P=0.471          P=0.192          P=0.238         | 
|POLY 6             |        P=0.434N         P=0.041 *        P=0.030 *        P=0.396          P=0.154          P=0.244         | 
|LOGISTIC REGRESSION|        P=0.450N         P=0.050          P=0.046 *        P=0.473          P=0.227          P=0.281         | 
|COCH-ARM / FISHERS |        P=0.448N         P=0.069          P=0.046 *        P=0.500          P=0.255          P=0.255         | 
|ORDER RESTRICTED   |        P=0.155          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          6 NG/KG          20 NG/KG         44 NG/KG         92 NG/KG         200             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        48/53 (91%)      49/53 (92%)      49/53 (92%)      44/53 (83%)      48/53 (91%)      46/53 (87%)     | 
|POLY-3 RATE (b)    |        48/51.69         49/50.68         49/49.46         44/49.02         48/49.59         46/49.29        | 
|POLY-3 PERCENT (g) |        92.9%            96.7%            99.1%            89.8%            96.8%            93.3%           | 
|TERMINAL (d)       |        22/25 (88%)      21/22 (96%)      24/24 (100%)     22/25 (88%)      19/20 (95%)      21/23 (91%)     | 
|FIRST INCIDENCE    |        289              289              196              302              113              326             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.408          P=0.200          P=0.250          P=0.521N         P=0.152          P=0.348         | 
|POLY 3             |        P=0.415N         P=0.325          P=0.121          P=0.414N         P=0.317          P=0.626         | 
|POLY 1.5           |        P=0.352N         P=0.386          P=0.183          P=0.291N         P=0.406          P=0.601N        | 
|POLY 6             |        P=0.492N         P=0.287          P=0.103          P=0.566N         P=0.283          P=0.550         | 
|LOGISTIC REGRESSION|        P=0.342N         P=0.430          P=0.255          P=0.224N         P=0.452          P=0.512N        | 
|COCH-ARM / FISHERS |        P=0.253N         P=0.500          P=0.500          P=0.195N         P=0.629N         P=0.380N        | 
|ORDER RESTRICTED   |        P=0.422N         (e)              (e)              (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).