National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/17045

TDMS Study 96021-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:07:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                    FINAL#4 RATS CTRL VS TREATED                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 002    10 UG/KG                                                                      
                                       INCLUDE 003    100     UG/KG                                                                 
                                       INCLUDE 004    300     UG/KG                                                                 
                                       INCLUDE 005    1000    UG/KG                                                                 
                                       INCLUDE 006    3000    UG/KG                                                                 
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:07:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
Rats(SPRAGUE-DAWLEY)                                                                                                                
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Bone Marrow                                                                        
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 12/15/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 11:07:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Uterus                                 Polyp Stromal                                                                                
Vagina                                 Schwannoma Malignant                                                                         
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -       TOXIC EQUIVALENCY FACTOR EVALUATION (                 
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/54 (2%)        4/53 (8%)        4/53 (8%)        2/53 (4%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        2/39.13          1/31.01          4/41.12          4/36.33          2/38.33          3/33.81         | 
|POLY-3 PERCENT (g) |        5.1%             3.2%             9.7%             11.0%            5.2%             8.9%            | 
|TERMINAL (d)       |        1/24 (4%)        1/16 (6%)        4/28 (14%)       4/21 (19%)       2/20 (10%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        701              731 (T)          731 (T)          731 (T)          731 (T)          586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.467          P=0.635N         P=0.412          P=0.276          P=0.641          P=0.421         | 
|POLY 3             |        P=0.486          P=0.580N         P=0.359          P=0.301          P=0.688          P=0.433         | 
|POLY 1.5           |        P=0.490          P=0.551N         P=0.351          P=0.309          P=0.691          P=0.449         | 
|POLY 6             |        P=0.486          P=0.607N         P=0.374          P=0.296          P=0.682          P=0.426         | 
|LOGISTIC REGRESSION|        P=0.447          P=0.629N         P=0.409          P=0.287          P=0.676          P=0.425         | 
|COCH-ARM / FISHERS |        P=0.489          P=0.493N         P=0.339          P=0.339          P=0.691N         P=0.482         | 
|ORDER RESTRICTED   |        P=0.414          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/53 (6%)        2/54 (4%)        4/53 (8%)        4/53 (8%)        2/53 (4%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        3/39.55          2/31.01          4/41.12          4/36.33          2/38.33          3/33.81         | 
|POLY-3 PERCENT (g) |        7.6%             6.5%             9.7%             11.0%            5.2%             8.9%            | 
|TERMINAL (d)       |        1/24 (4%)        2/16 (13%)       4/28 (14%)       4/21 (19%)       2/20 (10%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        608              731 (T)          731 (T)          731 (T)          731 (T)          586             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.589N         P=0.664N         P=0.573          P=0.434          P=0.553N         P=0.569         | 
|POLY 3             |        P=0.572N         P=0.609N         P=0.521          P=0.453          P=0.514N         P=0.589         | 
|POLY 1.5           |        P=0.565N         P=0.569N         P=0.514          P=0.464          P=0.506N         P=0.608         | 
|POLY 6             |        P=0.578N         P=0.647N         P=0.534          P=0.443          P=0.527N         P=0.578         | 
|LOGISTIC REGRESSION|        P=0.579          P=0.638N         P=0.551          P=0.457          P=0.514N         P=0.597         | 
|COCH-ARM / FISHERS |        P=0.563N         P=0.491N         P=0.500          P=0.500          P=0.500N         P=0.642         | 
|ORDER RESTRICTED   |        P=0.686N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangioma                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          0/36.33          2/38.45          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              702              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.616          (e)              (e)              (e)              P=0.224          (e)             | 
|POLY 3             |        P=0.568          (e)              (e)              (e)              P=0.233          (e)             | 
|POLY 1.5           |        P=0.587          (e)              (e)              (e)              P=0.236          (e)             | 
|POLY 6             |        P=0.552          (e)              (e)              (e)              P=0.230          (e)             | 
|LOGISTIC REGRESSION|        P=0.605          (e)              (e)              (e)              P=0.226          (e)             | 
|COCH-ARM / FISHERS |        P=0.615          (e)              (e)              (e)              P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.187          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Alveolar/Bronchiolar Adenoma                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/52 (2%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        1/38.91          0/31.01          0/41.12          0/36.33          2/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             0.0%             0.0%             5.2%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        2/20 (10%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        701              ---              ---              ---              731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.687N         P=0.573N         P=0.465N         P=0.524N         P=0.453          P=0.533N        | 
|POLY 3             |        P=0.693N         P=0.545N         P=0.489N         P=0.514N         P=0.495          P=0.532N        | 
|POLY 1.5           |        P=0.685N         P=0.527N         P=0.492N         P=0.510N         P=0.501          P=0.522N        | 
|POLY 6             |        P=0.700          P=0.561N         P=0.483N         P=0.516N         P=0.487          P=0.540N        | 
|LOGISTIC REGRESSION|        P=0.697N         P=0.561N         P=0.485N         P=0.514N         P=0.481          P=0.536N        | 
|COCH-ARM / FISHERS |        P=0.677N         P=0.491N         P=0.495N         P=0.495N         P=0.507          P=0.505N        | 
|ORDER RESTRICTED   |        P=0.319N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        1/53 (2%)        1/53 (2%)        3/53 (6%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        2/39.01          0/31.01          1/41.12          1/36.33          3/38.33          2/33.52         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             2.4%             2.8%             7.8%             6.0%            | 
|TERMINAL (d)       |        2/24 (8%)        0/16 (0%)        1/28 (4%)        1/21 (5%)        3/20 (15%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        731 (T)          ---              731 (T)          731 (T)          731 (T)          612             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.253          P=0.330N         P=0.446N         P=0.547N         P=0.415          P=0.636         | 
|POLY 3             |        P=0.255          P=0.291N         P=0.482N         P=0.525N         P=0.492          P=0.639         | 
|POLY 1.5           |        P=0.262          P=0.271N         P=0.489N         P=0.520N         P=0.497          P=0.653         | 
|POLY 6             |        P=0.250          P=0.310N         P=0.469N         P=0.527N         P=0.485          P=0.633         | 
|LOGISTIC REGRESSION|        P=0.236          (e)              P=0.446N         P=0.547N         P=0.415          P=0.628         | 
|COCH-ARM / FISHERS |        P=0.268          P=0.243N         P=0.500N         P=0.500N         P=0.500          P=0.676         | 
|ORDER RESTRICTED   |        P=0.330          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/53 (15%)       6/54 (11%)       7/53 (13%)       5/53 (9%)        6/53 (11%)       2/51 (4%)       | 
|POLY-3 RATE (b)    |        8/39.57          6/34.92          7/44.00          5/38.04          6/39.84          2/34.52         | 
|POLY-3 PERCENT (g) |        20.2%            17.2%            15.9%            13.1%            15.1%            5.8%            | 
|TERMINAL (d)       |        6/24 (25%)       1/16 (6%)        2/28 (7%)        1/21 (5%)        4/20 (20%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        608              250              443              263              452              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.072N         P=0.602          P=0.416N         P=0.353N         P=0.486N         P=0.083N        | 
|POLY 3             |        P=0.072N         P=0.485N         P=0.410N         P=0.297N         P=0.378N         P=0.068N        | 
|POLY 1.5           |        P=0.063N         P=0.448N         P=0.446N         P=0.298N         P=0.379N         P=0.061N        | 
|POLY 6             |        P=0.082N         P=0.514N         P=0.363N         P=0.290N         P=0.384N         P=0.071N        | 
|LOGISTIC REGRESSION|        P=0.054N         P=0.368N         P=0.493N         P=0.310N         P=0.398N         P=0.060N        | 
|COCH-ARM / FISHERS |        P=0.058N         P=0.373N         P=0.500N         P=0.278N         P=0.388N         P=0.053N        | 
|ORDER RESTRICTED   |        P=0.066N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/53 (17%)       6/54 (11%)       8/53 (15%)       5/53 (9%)        7/53 (13%)       3/51 (6%)       | 
|POLY-3 RATE (b)    |        9/39.57          6/34.92          8/44.00          5/38.04          7/39.84          3/34.52         | 
|POLY-3 PERCENT (g) |        22.8%            17.2%            18.2%            13.1%            17.6%            8.7%            | 
|TERMINAL (d)       |        7/24 (29%)       1/16 (6%)        3/28 (11%)       1/21 (5%)        5/20 (25%)       1/21 (5%)       | 
|FIRST INCIDENCE    |        608              250              443              263              452              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.116N         P=0.531N         P=0.404N         P=0.265N         P=0.506N         P=0.106N        | 
|POLY 3             |        P=0.118N         P=0.378N         P=0.403N         P=0.208N         P=0.383N         P=0.090N        | 
|POLY 1.5           |        P=0.105N         P=0.344N         P=0.442N         P=0.210N         P=0.384N         P=0.081N        | 
|POLY 6             |        P=0.134N         P=0.405N         P=0.351N         P=0.201N         P=0.389N         P=0.095N        | 
|LOGISTIC REGRESSION|        P=0.094N         P=0.290N         P=0.483N         P=0.225N         P=0.408N         P=0.087N        | 
|COCH-ARM / FISHERS |        P=0.097N         P=0.276N         P=0.500N         P=0.195N         P=0.393N         P=0.070N        | 
|ORDER RESTRICTED   |        P=0.086N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        41/53 (77%)      34/54 (63%)      36/53 (68%)      35/53 (66%)      39/53 (74%)      32/51 (63%)     | 
|POLY-3 RATE (b)    |        41/49.26         34/43.20         36/47.95         35/46.05         39/49.19         32/44.62        | 
|POLY-3 PERCENT (g) |        83.2%            78.7%            75.1%            76.0%            79.3%            71.7%           | 
|TERMINAL (d)       |        19/24 (79%)      13/16 (81%)      22/28 (79%)      14/21 (67%)      13/20 (65%)      13/21 (62%)     | 
|FIRST INCIDENCE    |        399              310              418              269              341              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.459N         P=0.291          P=0.103N         P=0.422N         P=0.481          P=0.393N        | 
|POLY 3             |        P=0.190N         P=0.377N         P=0.214N         P=0.255N         P=0.399N         P=0.123N        | 
|POLY 1.5           |        P=0.208N         P=0.237N         P=0.188N         P=0.230N         P=0.393N         P=0.103N        | 
|POLY 6             |        P=0.182N         P=0.513N         P=0.262N         P=0.266N         P=0.398N         P=0.148N        | 
|LOGISTIC REGRESSION|        P=0.295N         P=0.206N         P=0.166N         P=0.192N         P=0.413N         P=0.095N        | 
|COCH-ARM / FISHERS |        P=0.266N         P=0.078N         P=0.192N         P=0.140N         P=0.411N         P=0.078N        | 
|ORDER RESTRICTED   |        P=0.128N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 5       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        41/53 (77%)      34/54 (63%)      36/53 (68%)      36/53 (68%)      41/53 (77%)      33/51 (65%)     | 
|POLY-3 RATE (b)    |        41/49.26         34/43.20         36/47.95         36/46.05         41/49.19         33/44.62        | 
|POLY-3 PERCENT (g) |        83.2%            78.7%            75.1%            78.2%            83.4%            74.0%           | 
|TERMINAL (d)       |        19/24 (79%)      13/16 (81%)      22/28 (79%)      15/21 (71%)      15/20 (75%)      14/21 (67%)     | 
|FIRST INCIDENCE    |        399              310              418              269              341              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.527          P=0.291          P=0.103N         P=0.480N         P=0.366          P=0.452N        | 
|POLY 3             |        P=0.294N         P=0.377N         P=0.214N         P=0.349N         P=0.607          P=0.184N        | 
|POLY 1.5           |        P=0.310N         P=0.237N         P=0.188N         P=0.313N         P=0.599N         P=0.154N        | 
|POLY 6             |        P=0.291N         P=0.513N         P=0.262N         P=0.368N         P=0.609          P=0.222N        | 
|LOGISTIC REGRESSION|        P=0.401N         P=0.206N         P=0.166N         P=0.262N         P=0.590          P=0.141N        | 
|COCH-ARM / FISHERS |        P=0.363N         P=0.078N         P=0.192N         P=0.192N         P=0.592N         P=0.114N        | 
|ORDER RESTRICTED   |        P=0.206N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        43/53 (81%)      37/54 (69%)      40/53 (75%)      38/53 (72%)      42/53 (79%)      34/51 (67%)     | 
|POLY-3 RATE (b)    |        43/49.39         37/45.93         40/50.65         38/47.11         42/49.93         34/45.62        | 
|POLY-3 PERCENT (g) |        87.1%            80.6%            79.0%            80.7%            84.1%            74.5%           | 
|TERMINAL (d)       |        20/24 (83%)      13/16 (81%)      22/28 (79%)      15/21 (71%)      15/20 (75%)      14/21 (67%)     | 
|FIRST INCIDENCE    |        399              250              418              263              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.408N         P=0.230          P=0.173N         P=0.492N         P=0.414          P=0.409N        | 
|POLY 3             |        P=0.158N         P=0.260N         P=0.195N         P=0.268N         P=0.445N         P=0.081N        | 
|POLY 1.5           |        P=0.147N         P=0.184N         P=0.223N         P=0.252N         P=0.453N         P=0.069N        | 
|POLY 6             |        P=0.176N         P=0.357N         P=0.185N         P=0.277N         P=0.437N         P=0.103N        | 
|LOGISTIC REGRESSION|        P=0.199N         P=0.186N         P=0.308N         P=0.247N         P=0.502N         P=0.080N        | 
|COCH-ARM / FISHERS |        P=0.187N         P=0.100N         P=0.319N         P=0.180N         P=0.500N         P=0.072N        | 
|ORDER RESTRICTED   |        P=0.077N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 6       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.41          0/41.12          1/36.33          0/38.33          1/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             0.0%             2.8%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              616              ---              731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.591          P=0.177          (e)              P=0.473          (e)              P=0.473         | 
|POLY 3             |        P=0.545          P=0.192          (e)              P=0.486          (e)              P=0.467         | 
|POLY 1.5           |        P=0.566          P=0.207          (e)              P=0.488          (e)              P=0.476         | 
|POLY 6             |        P=0.524          P=0.180          (e)              P=0.485          (e)              P=0.461         | 
|LOGISTIC REGRESSION|        P=0.588          P=0.188          (e)              P=0.473          (e)              P=0.473         | 
|COCH-ARM / FISHERS |        P=0.604          P=0.252          (e)              P=0.500          (e)              P=0.490         | 
|ORDER RESTRICTED   |        P=0.309          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.41          0/41.12          1/36.33          0/38.33          1/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             0.0%             2.8%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              616              ---              731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.591          P=0.177          (e)              P=0.473          (e)              P=0.473         | 
|POLY 3             |        P=0.545          P=0.192          (e)              P=0.486          (e)              P=0.467         | 
|POLY 1.5           |        P=0.566          P=0.207          (e)              P=0.488          (e)              P=0.476         | 
|POLY 6             |        P=0.524          P=0.180          (e)              P=0.485          (e)              P=0.461         | 
|LOGISTIC REGRESSION|        P=0.588          P=0.188          (e)              P=0.473          (e)              P=0.473         | 
|COCH-ARM / FISHERS |        P=0.604          P=0.252          (e)              P=0.500          (e)              P=0.490         | 
|ORDER RESTRICTED   |        P=0.309          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 7       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        0/53 (0%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.41          0/41.12          1/36.33          0/38.33          1/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             0.0%             2.8%             0.0%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        ---              616              ---              731 (T)          ---              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.591          P=0.177          (e)              P=0.473          (e)              P=0.473         | 
|POLY 3             |        P=0.545          P=0.192          (e)              P=0.486          (e)              P=0.467         | 
|POLY 1.5           |        P=0.566          P=0.207          (e)              P=0.488          (e)              P=0.476         | 
|POLY 6             |        P=0.524          P=0.180          (e)              P=0.485          (e)              P=0.461         | 
|LOGISTIC REGRESSION|        P=0.588          P=0.188          (e)              P=0.473          (e)              P=0.473         | 
|COCH-ARM / FISHERS |        P=0.604          P=0.252          (e)              P=0.500          (e)              P=0.490         | 
|ORDER RESTRICTED   |        P=0.309          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Parathyroid Gland                                                                                                                | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/49 (0%)        0/46 (0%)        0/50 (0%)        0/47 (0%)        2/46 (4%)        0/48 (0%)       | 
|POLY-3 RATE (b)    |        0/36.68          0/27.75          0/38.12          0/32.21          2/33.00          0/30.97         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             6.1%             0.0%            | 
|TERMINAL (d)       |        0/23 (0%)        0/15 (0%)        0/25 (0%)        0/18 (0%)        1/16 (6%)        0/20 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              579              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.609          (e)              (e)              (e)              P=0.200          (e)             | 
|POLY 3             |        P=0.565          (e)              (e)              (e)              P=0.213          (e)             | 
|POLY 1.5           |        P=0.586          (e)              (e)              (e)              P=0.218          (e)             | 
|POLY 6             |        P=0.551          (e)              (e)              (e)              P=0.206          (e)             | 
|LOGISTIC REGRESSION|        P=0.614          (e)              (e)              (e)              P=0.220          (e)             | 
|COCH-ARM / FISHERS |        P=0.621          (e)              (e)              (e)              P=0.232          (e)             | 
|ORDER RESTRICTED   |        P=0.165          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 8       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      19/54 (35%)      19/53 (36%)      19/53 (36%)      24/53 (45%)      11/50 (22%)     | 
|POLY-3 RATE (b)    |        18/41.75         19/34.40         19/42.89         19/39.93         24/41.43         11/34.40        | 
|POLY-3 PERCENT (g) |        43.1%            55.2%            44.3%            47.6%            57.9%            32.0%           | 
|TERMINAL (d)       |        10/24 (42%)      10/16 (63%)      13/28 (46%)      9/21 (43%)       12/20 (60%)      7/21 (33%)      | 
|FIRST INCIDENCE    |        211              502              429              443              579              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.114N         P=0.101          P=0.440N         P=0.376          P=0.099          P=0.217N        | 
|POLY 3             |        P=0.120N         P=0.195          P=0.545          P=0.425          P=0.116          P=0.218N        | 
|POLY 1.5           |        P=0.096N         P=0.287          P=0.524          P=0.422          P=0.129          P=0.184N        | 
|POLY 6             |        P=0.159N         P=0.142          P=0.579          P=0.450          P=0.109          P=0.255N        | 
|LOGISTIC REGRESSION|        P=0.095N         P=0.175          P=0.574          P=0.406          P=0.128          P=0.204N        | 
|COCH-ARM / FISHERS |        P=0.081N         P=0.528          P=0.500          P=0.500          P=0.160          P=0.129N        | 
|ORDER RESTRICTED   |        P=0.095N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      19/54 (35%)      19/53 (36%)      19/53 (36%)      24/53 (45%)      12/50 (24%)     | 
|POLY-3 RATE (b)    |        18/41.75         19/34.40         19/42.89         19/39.93         24/41.43         12/34.62        | 
|POLY-3 PERCENT (g) |        43.1%            55.2%            44.3%            47.6%            57.9%            34.7%           | 
|TERMINAL (d)       |        10/24 (42%)      10/16 (63%)      13/28 (46%)      9/21 (43%)       12/20 (60%)      7/21 (33%)      | 
|FIRST INCIDENCE    |        211              502              429              443              579              486             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.171N         P=0.101          P=0.440N         P=0.376          P=0.099          P=0.294N        | 
|POLY 3             |        P=0.182N         P=0.195          P=0.545          P=0.425          P=0.116          P=0.298N        | 
|POLY 1.5           |        P=0.151N         P=0.287          P=0.524          P=0.422          P=0.129          P=0.257N        | 
|POLY 6             |        P=0.226N         P=0.142          P=0.579          P=0.450          P=0.109          P=0.336N        | 
|LOGISTIC REGRESSION|        P=0.152N         P=0.175          P=0.574          P=0.406          P=0.128          P=0.283N        | 
|COCH-ARM / FISHERS |        P=0.127N         P=0.528          P=0.500          P=0.500          P=0.160          P=0.185N        | 
|ORDER RESTRICTED   |        P=0.158N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 9       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor                                                                       | 
|     (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        1/51 (2%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.14          0/41.12          1/36.33          2/39.53          1/33.89         | 
|POLY-3 PERCENT (g) |        0.0%             6.4%             0.0%             2.8%             5.1%             3.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        0/28 (0%)        1/21 (5%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              696              ---              731 (T)          479              443             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.479          P=0.158          (e)              P=0.473          P=0.239          P=0.482         | 
|POLY 3             |        P=0.436          P=0.190          (e)              P=0.486          P=0.239          P=0.472         | 
|POLY 1.5           |        P=0.459          P=0.207          (e)              P=0.488          P=0.239          P=0.479         | 
|POLY 6             |        P=0.415          P=0.177          (e)              P=0.485          P=0.240          P=0.468         | 
|LOGISTIC REGRESSION|        P=0.500          P=0.164          (e)              P=0.473          P=0.224          P=0.576         | 
|COCH-ARM / FISHERS |        P=0.499          P=0.252          (e)              P=0.500          P=0.248          P=0.490         | 
|ORDER RESTRICTED   |        P=0.255          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        2/53 (4%)        1/53 (2%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          2/41.59          1/36.49          1/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             2.7%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        0/21 (0%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              591              691              731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.449N         (e)              P=0.257          P=0.485          P=0.464          (e)             | 
|POLY 3             |        P=0.420N         (e)              P=0.251          P=0.487          P=0.497          (e)             | 
|POLY 1.5           |        P=0.421N         (e)              P=0.246          P=0.489          P=0.499          (e)             | 
|POLY 6             |        P=0.418N         (e)              P=0.261          P=0.487          P=0.494          (e)             | 
|LOGISTIC REGRESSION|        P=0.443N         (e)              P=0.240          P=0.486          P=0.464          (e)             | 
|COCH-ARM / FISHERS |        P=0.429N         (e)              P=0.248          P=0.500          P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.365          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 10      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        3/53 (6%)        1/53 (2%)        3/53 (6%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/32.88          3/41.86          1/36.49          3/39.06          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.1%             7.2%             2.7%             7.7%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        0/21 (0%)        1/20 (5%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              261              591              691              510              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.294N         P=0.235          P=0.144          P=0.485          P=0.111          (e)             | 
|POLY 3             |        P=0.312N         P=0.201          P=0.131          P=0.487          P=0.118          (e)             | 
|POLY 1.5           |        P=0.298N         P=0.214          P=0.126          P=0.489          P=0.119          (e)             | 
|POLY 6             |        P=0.325N         P=0.189          P=0.140          P=0.487          P=0.116          (e)             | 
|LOGISTIC REGRESSION|        P=0.270N         P=0.492          P=0.122          P=0.486          P=0.120          (e)             | 
|COCH-ARM / FISHERS |        P=0.277N         P=0.252          P=0.121          P=0.500          P=0.121          (e)             | 
|ORDER RESTRICTED   |        P=0.266          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        2/53 (4%)        0/53 (0%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/32.88          2/41.39          0/36.33          2/39.06          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.1%             4.8%             0.0%             5.1%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        1/28 (4%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              261              656              ---              510              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.344N         P=0.235          P=0.277          (e)              P=0.235          (e)             | 
|POLY 3             |        P=0.370N         P=0.201          P=0.250          (e)              P=0.237          (e)             | 
|POLY 1.5           |        P=0.356N         P=0.214          P=0.245          (e)              P=0.238          (e)             | 
|POLY 6             |        P=0.382N         P=0.189          P=0.260          (e)              P=0.236          (e)             | 
|LOGISTIC REGRESSION|        P=0.323N         P=0.492          P=0.250          (e)              P=0.238          (e)             | 
|COCH-ARM / FISHERS |        P=0.335N         P=0.252          P=0.248          (e)              P=0.248          (e)             | 
|ORDER RESTRICTED   |        P=0.328N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 11      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        16/51 (31%)      13/52 (25%)      17/53 (32%)      12/53 (23%)      22/53 (42%)      7/51 (14%)      | 
|POLY-3 RATE (b)    |        16/39.99         13/32.09         17/43.11         12/38.16         22/40.39         7/33.34         | 
|POLY-3 PERCENT (g) |        40.0%            40.5%            39.4%            31.5%            54.5%            21.0%           | 
|TERMINAL (d)       |        10/24 (42%)      10/16 (63%)      11/28 (39%)      7/21 (33%)       15/20 (75%)      6/21 (29%)      | 
|FIRST INCIDENCE    |        555              438              443              528              555              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.075N         P=0.378          P=0.478N         P=0.373N         P=0.063          P=0.069N        | 
|POLY 3             |        P=0.090N         P=0.581          P=0.569N         P=0.285N         P=0.129          P=0.062N        | 
|POLY 1.5           |        P=0.065N         P=0.500N         P=0.583N         P=0.271N         P=0.157          P=0.045N*       | 
|POLY 6             |        P=0.131N         P=0.470          P=0.545N         P=0.297N         P=0.099          P=0.085N        | 
|LOGISTIC REGRESSION|        P=0.070N         P=0.510          P=0.562N         P=0.296N         P=0.121          P=0.064N        | 
|COCH-ARM / FISHERS |        P=0.049N*        P=0.309N         P=0.553          P=0.217N         P=0.192          P=0.028N*       | 
|ORDER RESTRICTED   |        P=0.051N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/51 (4%)        2/52 (4%)        1/53 (2%)        1/53 (2%)        2/53 (4%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/38.11          2/30.30          1/41.12          1/36.64          2/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        5.3%             6.6%             2.4%             2.7%             5.2%             0.0%            | 
|TERMINAL (d)       |        2/24 (8%)        2/16 (13%)       1/28 (4%)        0/21 (0%)        2/20 (10%)       0/21 (0%)       | 
|FIRST INCIDENCE    |        731 (T)          731 (T)          731 (T)          647              731 (T)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.223N         P=0.542          P=0.446N         P=0.527N         P=0.630          P=0.267N        | 
|POLY 3             |        P=0.238N         P=0.609          P=0.473N         P=0.514N         P=0.693N         P=0.269N        | 
|POLY 1.5           |        P=0.226N         P=0.641          P=0.478N         P=0.509N         P=0.686N         P=0.258N        | 
|POLY 6             |        P=0.253N         P=0.579          P=0.464N         P=0.515N         P=0.690          P=0.278N        | 
|LOGISTIC REGRESSION|        P=0.225N         P=0.542          P=0.446N         P=0.521N         P=0.630          (e)             | 
|COCH-ARM / FISHERS |        P=0.209N         P=0.684N         P=0.485N         P=0.485N         P=0.676N         P=0.248N        | 
|ORDER RESTRICTED   |        P=0.169N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 12      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/51 (35%)      15/52 (29%)      18/53 (34%)      13/53 (25%)      23/53 (43%)      7/51 (14%)      | 
|POLY-3 RATE (b)    |        18/39.99         15/32.09         18/43.11         13/38.46         23/40.39         7/33.34         | 
|POLY-3 PERCENT (g) |        45.0%            46.8%            41.8%            33.8%            57.0%            21.0%           | 
|TERMINAL (d)       |        12/24 (50%)      12/16 (75%)      12/28 (43%)      7/21 (33%)       16/20 (80%)      6/21 (29%)      | 
|FIRST INCIDENCE    |        555              438              443              528              555              668             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.032N*        P=0.308          P=0.382N         P=0.309N         P=0.081          P=0.028N*       | 
|POLY 3             |        P=0.038N*        P=0.538          P=0.468N         P=0.209N         P=0.185          P=0.023N*       | 
|POLY 1.5           |        P=0.027N*        P=0.526N         P=0.487N         P=0.203N         P=0.219          P=0.016N*       | 
|POLY 6             |        P=0.060N         P=0.408          P=0.437N         P=0.208N         P=0.146          P=0.033N*       | 
|LOGISTIC REGRESSION|        P=0.028N*        P=0.435          P=0.460N         P=0.233N         P=0.167          P=0.026N*       | 
|COCH-ARM / FISHERS |        P=0.021N*        P=0.312N         P=0.525N         P=0.162N         P=0.260          P=0.010N*       | 
|ORDER RESTRICTED   |        P=0.018N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        2/53 (4%)        0/53 (0%)        1/53 (2%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.14          2/41.96          0/36.33          1/38.34          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             4.8%             0.0%             2.6%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              696              527              ---              729              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.399N         P=0.423          P=0.262          (e)              P=0.473          (e)             | 
|POLY 3             |        P=0.384N         P=0.455          P=0.253          (e)              P=0.497          (e)             | 
|POLY 1.5           |        P=0.379N         P=0.472          P=0.247          (e)              P=0.499          (e)             | 
|POLY 6             |        P=0.388N         P=0.442          P=0.265          (e)              P=0.494          (e)             | 
|LOGISTIC REGRESSION|        P=0.382N         P=0.442          P=0.220          (e)              P=0.482          (e)             | 
|COCH-ARM / FISHERS |        P=0.376N         P=0.505          P=0.248          (e)              P=0.500          (e)             | 
|ORDER RESTRICTED   |        P=0.365N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 13      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Leiomyosarcoma                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/54 (0%)        0/53 (0%)        3/53 (6%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          0/31.01          0/41.12          3/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             8.3%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        3/21 (14%)       0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              ---              731 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.450N         (e)              (e)              P=0.096          (e)              (e)             | 
|POLY 3             |        P=0.454N         (e)              (e)              P=0.105          (e)              (e)             | 
|POLY 1.5           |        P=0.451N         (e)              (e)              P=0.108          (e)              (e)             | 
|POLY 6             |        P=0.460N         (e)              (e)              P=0.103          (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              P=0.096          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.444N         (e)              (e)              P=0.121          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.276          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/53 (13%)       9/54 (17%)       4/53 (8%)        6/53 (11%)       3/53 (6%)        2/51 (4%)       | 
|POLY-3 RATE (b)    |        7/39.74          9/32.68          4/41.73          6/37.10          3/39.40          2/33.11         | 
|POLY-3 PERCENT (g) |        17.6%            27.5%            9.6%             16.2%            7.6%             6.0%            | 
|TERMINAL (d)       |        4/24 (17%)       5/16 (31%)       3/28 (11%)       3/21 (14%)       1/20 (5%)        2/21 (10%)      | 
|FIRST INCIDENCE    |        590              590              530              647              467              731 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.047N*        P=0.148          P=0.201N         P=0.578N         P=0.209N         P=0.129N        | 
|POLY 3             |        P=0.051N         P=0.232          P=0.230N         P=0.554N         P=0.156N         P=0.126N        | 
|POLY 1.5           |        P=0.044N*        P=0.285          P=0.242N         P=0.545N         P=0.156N         P=0.112N        | 
|POLY 6             |        P=0.060N         P=0.197          P=0.213N         P=0.556N         P=0.159N         P=0.140N        | 
|LOGISTIC REGRESSION|        P=0.041N*        P=0.189          P=0.226N         P=0.558N         P=0.163N         P=0.129N        | 
|COCH-ARM / FISHERS |        P=0.037N*        P=0.409          P=0.263N         P=0.500N         P=0.160N         P=0.090N        | 
|ORDER RESTRICTED   |        P=0.035N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 14      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/54 (2%)        2/53 (4%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          1/31.22          2/41.12          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             3.2%             4.9%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        2/28 (7%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              675              731 (T)          ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.312N         P=0.433          P=0.272          (e)              (e)              (e)             | 
|POLY 3             |        P=0.297N         P=0.456          P=0.249          (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.297N         P=0.472          P=0.244          (e)              (e)              (e)             | 
|POLY 6             |        P=0.296N         P=0.443          P=0.256          (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.312N         P=0.455          P=0.272          (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.302N         P=0.505          P=0.248          (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.296N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Fibrosarcoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        2/54 (4%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        0/39.01          2/31.96          0/41.12          0/36.33          0/38.33          0/33.11         | 
|POLY-3 PERCENT (g) |        0.0%             6.3%             0.0%             0.0%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/24 (0%)        1/16 (6%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        ---              261              ---              ---              ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.392N         P=0.196          (e)              (e)              (e)              (e)             | 
|POLY 3             |        P=0.441N         P=0.195          (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        P=0.422N         P=0.210          (e)              (e)              (e)              (e)             | 
|POLY 6             |        P=0.460N         P=0.183          (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        P=0.380N         P=0.323          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.390N         P=0.252          (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.182N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 15      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Vagina                                                                                                                           | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        0/53 (0%)        3/51 (6%)       | 
|POLY-3 RATE (b)    |        1/39.14          0/31.01          0/41.12          0/36.33          0/38.33          3/34.55         | 
|POLY-3 PERCENT (g) |        2.6%             0.0%             0.0%             0.0%             0.0%             8.7%            | 
|TERMINAL (d)       |        0/24 (0%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        1/21 (5%)       | 
|FIRST INCIDENCE    |        696              ---              ---              ---              ---              442             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.006 **       P=0.577N         P=0.467N         P=0.539N         P=0.507N         P=0.253         | 
|POLY 3             |        P=0.007 **       P=0.546N         P=0.490N         P=0.515N         P=0.504N         P=0.260         | 
|POLY 1.5           |        P=0.007 **       P=0.529N         P=0.494N         P=0.512N         P=0.502N         P=0.270         | 
|POLY 6             |        P=0.007 **       P=0.561N         P=0.484N         P=0.517N         P=0.508N         P=0.255         | 
|LOGISTIC REGRESSION|        P=0.008 **       P=0.558N         P=0.487N         P=0.515N         P=0.505N         P=0.311         | 
|COCH-ARM / FISHERS |        P=0.007 **       P=0.495N         P=0.500N         P=0.500N         P=0.500N         P=0.294         | 
|ORDER RESTRICTED   |        P=0.006 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/54 (0%)        0/53 (0%)        0/53 (0%)        3/53 (6%)        0/51 (0%)       | 
|POLY-3 RATE (b)    |        2/39.53          0/31.01          0/41.12          0/36.33          3/39.68          0/33.11         | 
|POLY-3 PERCENT (g) |        5.1%             0.0%             0.0%             0.0%             7.6%             0.0%            | 
|TERMINAL (d)       |        1/24 (4%)        0/16 (0%)        0/28 (0%)        0/21 (0%)        0/20 (0%)        0/21 (0%)       | 
|FIRST INCIDENCE    |        571              ---              ---              ---              497              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.583N         P=0.318N         P=0.228N         P=0.269N         P=0.472          P=0.282N        | 
|POLY 3             |        P=0.591N         P=0.295N         P=0.228N         P=0.256N         P=0.502          P=0.278N        | 
|POLY 1.5           |        P=0.580N         P=0.272N         P=0.231N         P=0.252N         P=0.502          P=0.266N        | 
|POLY 6             |        P=0.603N         P=0.316N         P=0.222N         P=0.259N         P=0.500          P=0.287N        | 
|LOGISTIC REGRESSION|        P=0.567N         P=0.265N         P=0.237N         P=0.245N         P=0.500          P=0.258N        | 
|COCH-ARM / FISHERS |        P=0.569N         P=0.243N         P=0.248N         P=0.248N         P=0.500          P=0.257N        | 
|ORDER RESTRICTED   |        P=0.125N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 16      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        50/53 (94%)      41/54 (76%)      45/53 (85%)      46/53 (87%)      49/53 (92%)      40/51 (78%)     | 
|POLY-3 RATE (b)    |        50/51.13         41/44.71         45/50.28         46/48.45         49/50.80         40/45.55        | 
|POLY-3 PERCENT (g) |        97.8%            91.7%            89.5%            94.9%            96.5%            87.8%           | 
|TERMINAL (d)       |        24/24 (100%)     16/16 (100%)     25/28 (89%)      19/21 (91%)      19/20 (95%)      18/21 (86%)     | 
|FIRST INCIDENCE    |        211              310              418              269              341              360             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.477N         P=0.260          P=0.086N         P=0.530          P=0.377          P=0.414N        | 
|POLY 3             |        P=0.118N         P=0.114N         P=0.063N         P=0.396N         P=0.598N         P=0.034N*       | 
|POLY 1.5           |        P=0.125N         P=0.042N*        P=0.073N         P=0.384N         P=0.566N         P=0.028N*       | 
|POLY 6             |        P=0.134N         P=0.236N         P=0.065N         P=0.316N         P=0.586N         P=0.048N*       | 
|LOGISTIC REGRESSION|        P=0.212N         P=0.081N         P=0.076N         P=0.337N         P=0.483N         P=0.038N*       | 
|COCH-ARM / FISHERS |        P=0.183N         P=0.007N**       P=0.101N         P=0.160N         P=0.500N         P=0.017N*       | 
|ORDER RESTRICTED   |        P=0.015N*        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        12/53 (23%)      20/54 (37%)      16/53 (30%)      14/53 (26%)      14/53 (26%)      12/51 (24%)     | 
|POLY-3 RATE (b)    |        12/41.43         20/40.62         16/44.73         14/39.78         14/41.91         12/38.88        | 
|POLY-3 PERCENT (g) |        29.0%            49.2%            35.8%            35.2%            33.4%            30.9%           | 
|TERMINAL (d)       |        7/24 (29%)       6/16 (38%)       7/28 (25%)       6/21 (29%)       6/20 (30%)       3/21 (14%)      | 
|FIRST INCIDENCE    |        442              250              443              222              452              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.299N         P=0.015 *        P=0.388          P=0.318          P=0.312          P=0.421         | 
|POLY 3             |        P=0.248N         P=0.042 *        P=0.327          P=0.356          P=0.419          P=0.523         | 
|POLY 1.5           |        P=0.237N         P=0.052          P=0.296          P=0.367          P=0.420          P=0.532         | 
|POLY 6             |        P=0.254N         P=0.036 *        P=0.380          P=0.354          P=0.410          P=0.535         | 
|LOGISTIC REGRESSION|        P=0.221N         P=0.111          P=0.269          P=0.376          P=0.407          P=0.587N        | 
|COCH-ARM / FISHERS |        P=0.230N         P=0.078          P=0.255          P=0.411          P=0.411          P=0.549         | 
|ORDER RESTRICTED   |        P=0.402N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  12/15/03                           EXPERIMENT: 96021 TEST: 01                                            Page 17      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -       TOXIC EQUIVALENCY FACTOR EVALUATION (                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        52/53 (98%)      51/54 (94%)      49/53 (92%)      48/53 (91%)      51/53 (96%)      48/51 (94%)     | 
|POLY-3 RATE (b)    |        52/52.21         51/51.54         49/51.80         48/50.38         51/52.14         48/50.33        | 
|POLY-3 PERCENT (g) |        99.6%            99.0%            94.6%            95.3%            97.8%            95.4%           | 
|TERMINAL (d)       |        24/24 (100%)     16/16 (100%)     26/28 (93%)      19/21 (91%)      19/20 (95%)      19/21 (91%)     | 
|FIRST INCIDENCE    |        211              250              418              222              341              79              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.366          P=0.042 *        P=0.146N         P=0.521          P=0.380          P=0.335         | 
|POLY 3             |        P=0.327N         P=0.936N         P=0.146N         P=0.201N         P=0.527N         P=0.211N        | 
|POLY 1.5           |        P=0.400N         P=0.621N         P=0.145N         P=0.181N         P=0.528N         P=0.229N        | 
|POLY 6             |        P=0.284N         P=1.000N         P=0.181N         P=0.219N         P=0.510N         P=0.216N        | 
|LOGISTIC REGRESSION|        P=0.561          P=0.615N         P=0.154N         P=0.184N         P=0.478N         P=0.306N        | 
|COCH-ARM / FISHERS |        P=0.591          P=0.316N         P=0.181N         P=0.103N         P=0.500N         P=0.294N        | 
|ORDER RESTRICTED   |        P=0.145N         (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).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.