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TDMS Study 96007-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 09/29/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 12:03:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007B       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFDIOXINMIX    
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#4/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 09/29/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 12:03:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007B       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFDIOXINMIX    
Rats(SPRAGUE-DAWLEY)                                                                                                                
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Nose                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Parathyroid Gland                                                                  
                                                 Pituitary Gland                                                                    
                                                 Salivary Glands                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 09/29/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 12:03:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007B       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFDIOXINMIX    
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF  TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Liver                                  Cholangiocarcinoma                                                                           
                                       Hepatocellular Adenoma                                                                       
Lung                                   Cystic Keratinizing Epithelioma                                                              
Mammary Gland                          Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
                                       Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                 
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/52 (10%)       4/53 (8%)        4/53 (8%)        4/53 (8%)        1/51 (2%)                        | 
|POLY-3 RATE (b)    |        5/35.98          4/41.21          4/42.32          4/39.85          1/32.48                          | 
|POLY-3 PERCENT (g) |        13.9%            9.7%             9.5%             10.0%            3.1%                             | 
|TERMINAL (d)       |        3/16 (19%)       1/23 (4%)        1/24 (4%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        693              456              456              669              674                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.207N         P=0.345N         P=0.305N         P=0.333N         P=0.263N                         | 
|POLY 3             |        P=0.128N         P=0.414N         P=0.398N         P=0.435N         P=0.122N                         | 
|POLY 1.5           |        P=0.107N         P=0.441N         P=0.437N         P=0.454N         P=0.112N                         | 
|POLY 6             |        P=0.161N         P=0.383N         P=0.356N         P=0.411N         P=0.143N                         | 
|LOGISTIC REGRESSION|        P=0.109N         P=0.435N         P=0.414N         P=0.403N         P=0.180N                         | 
|COCH-ARM / FISHERS |        P=0.089N         P=0.488N         P=0.488N         P=0.488N         P=0.107N                         | 
|ORDER RESTRICTED   |        P=0.118N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Heart                                                                                                                            | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/53 (0%)        1/52 (2%)        3/53 (6%)                        | 
|POLY-3 RATE (b)    |        2/36.88          0/39.99          0/41.29          1/40.10          3/34.73                          | 
|POLY-3 PERCENT (g) |        5.4%             0.0%             0.0%             2.5%             8.6%                             | 
|TERMINAL (d)       |        1/16 (6%)        0/23 (0%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        526              ---              ---              465              312                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.080          P=0.189N         P=0.180N         P=0.441N         P=0.434                          | 
|POLY 3             |        P=0.090          P=0.219N         P=0.212N         P=0.471N         P=0.472                          | 
|POLY 1.5           |        P=0.098          P=0.225N         P=0.223N         P=0.483N         P=0.486                          | 
|POLY 6             |        P=0.081          P=0.212N         P=0.201N         P=0.458N         P=0.446                          | 
|LOGISTIC REGRESSION|        P=0.166          P=0.237N         P=0.237N         P=0.546N         P=0.553                          | 
|COCH-ARM / FISHERS |        P=0.111          P=0.248N         P=0.248N         P=0.507N         P=0.500                          | 
|ORDER RESTRICTED   |        P=0.077          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Islets, Pancreatic                                                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/52 (4%)        1/53 (2%)        1/53 (2%)        1/53 (2%)        0/51 (0%)                        | 
|POLY-3 RATE (b)    |        2/36.05          1/39.99          1/41.29          1/39.44          0/32.27                          | 
|POLY-3 PERCENT (g) |        5.6%             2.5%             2.4%             2.5%             0.0%                             | 
|TERMINAL (d)       |        1/16 (6%)        1/23 (4%)        1/24 (4%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        655              729 (T)          729 (T)          729 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.270N         P=0.402N         P=0.383N         P=0.395N         P=0.348N                         | 
|POLY 3             |        P=0.207N         P=0.464N         P=0.453N         P=0.469N         P=0.261N                         | 
|POLY 1.5           |        P=0.195N         P=0.473N         P=0.470N         P=0.477N         P=0.249N                         | 
|POLY 6             |        P=0.222N         P=0.454N         P=0.435N         P=0.460N         P=0.284N                         | 
|LOGISTIC REGRESSION|        P=0.231N         P=0.445N         P=0.427N         P=0.452N         P=0.280N                         | 
|COCH-ARM / FISHERS |        P=0.182N         P=0.493N         P=0.493N         P=0.493N         P=0.252N                         | 
|ORDER RESTRICTED   |        P=0.143N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiocarcinoma                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/53 (4%)        7/53 (13%)       9/51 (18%)                       | 
|POLY-3 RATE (b)    |        0/36.25          0/39.99          2/41.51          7/40.30          9/34.61                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             17.4%            26.0%                            | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        1/24 (4%)        5/23 (22%)       1/8 (13%)                        | 
|FIRST INCIDENCE    |        ---              ---              669              521              548                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.321          P=0.025 *        P<0.001 **                       | 
|POLY 3             |        P<0.001 **       (e)              P=0.268          P=0.011 *        P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.254          P=0.009 **       P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              P=0.285          P=0.012 *        P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.276          P=0.013 *        P=0.002 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.248          P=0.006 **       P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        1/53 (2%)        1/53 (2%)        1/53 (2%)        11/51 (22%)                      | 
|POLY-3 RATE (b)    |        0/36.25          1/39.99          1/41.29          1/39.44          11/35.45                         | 
|POLY-3 PERCENT (g) |        0.0%             2.5%             2.4%             2.5%             31.0%                            | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        1/24 (4%)        1/23 (4%)        2/8 (25%)                        | 
|FIRST INCIDENCE    |        ---              729 (T)          729 (T)          729 (T)          434                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.572          P=0.581          P=0.572          P<0.001 **                       | 
|POLY 3             |        P<0.001 **       P=0.520          P=0.526          P=0.517          P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P=0.513          P=0.514          P=0.511          P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P=0.528          P=0.539          P=0.524          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       P=0.572          P=0.581          P=0.572          P<0.001 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.500          P=0.500          P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Cystic Keratinizing Epithelioma                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        0/53 (0%)        2/53 (4%)        20/53 (38%)                      | 
|POLY-3 RATE (b)    |        0/36.25          0/39.99          0/41.29          2/39.57          20/36.59                         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             5.1%             54.7%                            | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        0/24 (0%)        1/23 (4%)        5/8 (63%)                        | 
|FIRST INCIDENCE    |        ---              ---              ---              697              542                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.300          P<0.001 **                       | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.256          P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.249          P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.266          P<0.001 **                       | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.271          P<0.001 **                       | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.248          P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/53 (11%)       6/53 (11%)       3/53 (6%)        5/53 (9%)        1/53 (2%)                        | 
|POLY-3 RATE (b)    |        6/38.75          6/42.31          3/41.42          5/41.78          1/32.91                          | 
|POLY-3 PERCENT (g) |        15.5%            14.2%            7.2%             12.0%            3.0%                             | 
|TERMINAL (d)       |        2/16 (13%)       3/23 (13%)       1/24 (4%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        218              227              702              276              548                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.111N         P=0.481N         P=0.137N         P=0.388N         P=0.120N                         | 
|POLY 3             |        P=0.081N         P=0.559N         P=0.207N         P=0.446N         P=0.084N                         | 
|POLY 1.5           |        P=0.065N         P=0.579N         P=0.225N         P=0.465N         P=0.072N                         | 
|POLY 6             |        P=0.105N         P=0.535N         P=0.187N         P=0.426N         P=0.105N                         | 
|LOGISTIC REGRESSION|        P=0.033N*        P=0.535          P=0.254N         P=0.584N         P=0.049N*                        | 
|COCH-ARM / FISHERS |        P=0.046N*        P=0.620N         P=0.244N         P=0.500N         P=0.056N                         | 
|ORDER RESTRICTED   |        P=0.080N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/53 (11%)       7/53 (13%)       3/53 (6%)        5/53 (9%)        1/53 (2%)                        | 
|POLY-3 RATE (b)    |        6/38.75          7/42.36          3/41.42          5/41.78          1/32.91                          | 
|POLY-3 PERCENT (g) |        15.5%            16.5%            7.2%             12.0%            3.0%                             | 
|TERMINAL (d)       |        2/16 (13%)       3/23 (13%)       1/24 (4%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        218              227              702              276              548                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.092N         P=0.579N         P=0.137N         P=0.388N         P=0.120N                         | 
|POLY 3             |        P=0.062N         P=0.570          P=0.207N         P=0.446N         P=0.084N                         | 
|POLY 1.5           |        P=0.050N         P=0.546          P=0.225N         P=0.465N         P=0.072N                         | 
|POLY 6             |        P=0.082N         P=0.597          P=0.187N         P=0.426N         P=0.105N                         | 
|LOGISTIC REGRESSION|        P=0.026N*        P=0.423          P=0.254N         P=0.584N         P=0.049N*                        | 
|COCH-ARM / FISHERS |        P=0.035N*        P=0.500          P=0.244N         P=0.500N         P=0.056N                         | 
|ORDER RESTRICTED   |        P=0.072N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 5       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      27/53 (51%)      35/53 (66%)      28/53 (53%)      18/53 (34%)                      | 
|POLY-3 RATE (b)    |        34/45.66         27/47.68         35/48.71         28/45.80         18/36.95                         | 
|POLY-3 PERCENT (g) |        74.5%            56.6%            71.9%            61.1%            48.7%                            | 
|TERMINAL (d)       |        11/16 (69%)      8/23 (35%)       16/24 (67%)      10/23 (44%)      6/8 (75%)                        | 
|FIRST INCIDENCE    |        176              362              263              333              409                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.258N         P=0.041N*        P=0.145N         P=0.047N*        P=0.183N                         | 
|POLY 3             |        P=0.024N*        P=0.047N*        P=0.477N         P=0.115N         P=0.008N**                       | 
|POLY 1.5           |        P=0.006N**       P=0.067N         P=0.565N         P=0.129N         P=0.003N**                       | 
|POLY 6             |        P=0.089N         P=0.033N*        P=0.400N         P=0.100N         P=0.031N*                        | 
|LOGISTIC REGRESSION|        P=0.002N**       P=0.107N         P=0.561          P=0.126N         P=0.003N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.119N         P=0.500          P=0.162N         P=0.002N**                       | 
|ORDER RESTRICTED   |        P=0.011N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        34/53 (64%)      28/53 (53%)      35/53 (66%)      28/53 (53%)      18/53 (34%)                      | 
|POLY-3 RATE (b)    |        34/45.66         28/47.72         35/48.71         28/45.80         18/36.95                         | 
|POLY-3 PERCENT (g) |        74.5%            58.7%            71.9%            61.1%            48.7%                            | 
|TERMINAL (d)       |        11/16 (69%)      8/23 (35%)       16/24 (67%)      10/23 (44%)      6/8 (75%)                        | 
|FIRST INCIDENCE    |        176              362              263              333              409                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.241N         P=0.055N         P=0.145N         P=0.047N*        P=0.183N                         | 
|POLY 3             |        P=0.018N*        P=0.072N         P=0.477N         P=0.115N         P=0.008N**                       | 
|POLY 1.5           |        P=0.005N**       P=0.098N         P=0.565N         P=0.129N         P=0.003N**                       | 
|POLY 6             |        P=0.074N         P=0.051N         P=0.400N         P=0.100N         P=0.031N*                        | 
|LOGISTIC REGRESSION|        P=0.002N**       P=0.143N         P=0.561          P=0.126N         P=0.003N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.162N         P=0.500          P=0.162N         P=0.002N**                       | 
|ORDER RESTRICTED   |        P=0.011N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 6       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        37/53 (70%)      33/53 (62%)      36/53 (68%)      31/53 (58%)      19/53 (36%)                      | 
|POLY-3 RATE (b)    |        37/48.01         33/50.04         36/48.82         31/48.14         19/37.52                         | 
|POLY-3 PERCENT (g) |        77.1%            65.9%            73.7%            64.4%            50.6%                            | 
|TERMINAL (d)       |        11/16 (69%)      10/23 (44%)      16/24 (67%)      10/23 (44%)      6/8 (75%)                        | 
|FIRST INCIDENCE    |        176              227              263              276              409                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.156N         P=0.093N         P=0.092N         P=0.055N         P=0.123N                         | 
|POLY 3             |        P=0.008N**       P=0.151N         P=0.441N         P=0.116N         P=0.005N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.188N         P=0.490N         P=0.128N         P=0.002N**                       | 
|POLY 6             |        P=0.042N*        P=0.118N         P=0.394N         P=0.104N         P=0.026N*                        | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.316N         P=0.475N         P=0.168N         P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.269N         P=0.500N         P=0.156N         P<0.001N**                       | 
|ORDER RESTRICTED   |        P=0.007N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        2/53 (4%)                        | 
|POLY-3 RATE (b)    |        1/36.48          1/40.53          0/41.29          0/39.44          2/33.59                          | 
|POLY-3 PERCENT (g) |        2.7%             2.5%             0.0%             0.0%             6.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668              563              ---              ---              434                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.232          P=0.730N         P=0.454N         P=0.443N         P=0.450                          | 
|POLY 3             |        P=0.261          P=0.737N         P=0.475N         P=0.484N         P=0.471                          | 
|POLY 1.5           |        P=0.270          P=0.746N         P=0.486N         P=0.490N         P=0.484                          | 
|POLY 6             |        P=0.251          P=0.727N         P=0.464N         P=0.478N         P=0.449                          | 
|LOGISTIC REGRESSION|        P=0.318          P=0.758          P=0.485N         P=0.488N         P=0.516                          | 
|COCH-ARM / FISHERS |        P=0.283          P=0.752N         P=0.500N         P=0.500N         P=0.500                          | 
|ORDER RESTRICTED   |        P=0.155          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 7       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        2/53 (4%)                        | 
|POLY-3 RATE (b)    |        1/36.48          1/40.53          0/41.29          0/39.44          2/33.59                          | 
|POLY-3 PERCENT (g) |        2.7%             2.5%             0.0%             0.0%             6.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668              563              ---              ---              434                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.232          P=0.730N         P=0.454N         P=0.443N         P=0.450                          | 
|POLY 3             |        P=0.261          P=0.737N         P=0.475N         P=0.484N         P=0.471                          | 
|POLY 1.5           |        P=0.270          P=0.746N         P=0.486N         P=0.490N         P=0.484                          | 
|POLY 6             |        P=0.251          P=0.727N         P=0.464N         P=0.478N         P=0.449                          | 
|LOGISTIC REGRESSION|        P=0.318          P=0.758          P=0.485N         P=0.488N         P=0.516                          | 
|COCH-ARM / FISHERS |        P=0.283          P=0.752N         P=0.500N         P=0.500N         P=0.500                          | 
|ORDER RESTRICTED   |        P=0.155          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        0/53 (0%)        0/53 (0%)        2/53 (4%)                        | 
|POLY-3 RATE (b)    |        1/36.48          1/40.53          0/41.29          0/39.44          2/33.59                          | 
|POLY-3 PERCENT (g) |        2.7%             2.5%             0.0%             0.0%             6.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        668              563              ---              ---              434                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.232          P=0.730N         P=0.454N         P=0.443N         P=0.450                          | 
|POLY 3             |        P=0.261          P=0.737N         P=0.475N         P=0.484N         P=0.471                          | 
|POLY 1.5           |        P=0.270          P=0.746N         P=0.486N         P=0.490N         P=0.484                          | 
|POLY 6             |        P=0.251          P=0.727N         P=0.464N         P=0.478N         P=0.449                          | 
|LOGISTIC REGRESSION|        P=0.318          P=0.758          P=0.485N         P=0.488N         P=0.516                          | 
|COCH-ARM / FISHERS |        P=0.283          P=0.752N         P=0.500N         P=0.500N         P=0.500                          | 
|ORDER RESTRICTED   |        P=0.155          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 8       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Granulosa Cell Tumor: Benign, Malignant, NOS                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        0/52 (0%)        2/53 (4%)        1/53 (2%)        1/51 (2%)                        | 
|POLY-3 RATE (b)    |        0/35.78          0/39.75          2/41.67          1/39.44          1/32.46                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             2.5%             3.1%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        1/24 (4%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              621              729 (T)          682                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.229          (e)              P=0.297          P=0.572          P=0.443                          | 
|POLY 3             |        P=0.327          (e)              P=0.272          P=0.519          P=0.481                          | 
|POLY 1.5           |        P=0.354          (e)              P=0.258          P=0.514          P=0.490                          | 
|POLY 6             |        P=0.289          (e)              P=0.288          P=0.526          P=0.465                          | 
|LOGISTIC REGRESSION|        P=0.322          (e)              P=0.260          P=0.572          P=0.468                          | 
|COCH-ARM / FISHERS |        P=0.379          (e)              P=0.252          P=0.505          P=0.495                          | 
|ORDER RESTRICTED   |        P=0.291          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/51 (0%)                        | 
|POLY-3 RATE (b)    |        0/35.78          0/39.99          2/41.29          0/39.44          0/32.27                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        2/24 (8%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              729 (T)          ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.656N         (e)              P=0.330          (e)              (e)                              | 
|POLY 3             |        P=0.506N         (e)              P=0.270          (e)              (e)                              | 
|POLY 1.5           |        P=0.504N         (e)              P=0.257          (e)              (e)                              | 
|POLY 6             |        P=0.509N         (e)              P=0.284          (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.330          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.504N         (e)              P=0.252          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.432          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 9       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        1/53 (2%)        0/53 (0%)        2/53 (4%)        0/51 (0%)                        | 
|POLY-3 RATE (b)    |        0/35.78          1/39.99          0/41.29          2/39.44          0/32.27                          | 
|POLY-3 PERCENT (g) |        0.0%             2.5%             0.0%             5.1%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        0/24 (0%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              729 (T)          ---              729 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.573          P=0.572          (e)              P=0.320          (e)                              | 
|POLY 3             |        P=0.623          P=0.522          (e)              P=0.259          (e)                              | 
|POLY 1.5           |        P=0.662          P=0.516          (e)              P=0.253          (e)                              | 
|POLY 6             |        P=0.560          P=0.529          (e)              P=0.266          (e)                              | 
|LOGISTIC REGRESSION|        (e)              P=0.572          (e)              P=0.320          (e)                              | 
|COCH-ARM / FISHERS |        P=0.648N         P=0.505          (e)              P=0.252          (e)                              | 
|ORDER RESTRICTED   |        P=0.333          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/52 (0%)        1/53 (2%)        2/53 (4%)        2/53 (4%)        0/51 (0%)                        | 
|POLY-3 RATE (b)    |        0/35.78          1/39.99          2/41.29          2/39.44          0/32.27                          | 
|POLY-3 PERCENT (g) |        0.0%             2.5%             4.8%             5.1%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        2/24 (8%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              729 (T)          729 (T)          729 (T)          ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.633          P=0.572          P=0.330          P=0.320          (e)                              | 
|POLY 3             |        P=0.533N         P=0.522          P=0.270          P=0.259          (e)                              | 
|POLY 1.5           |        P=0.506N         P=0.516          P=0.257          P=0.253          (e)                              | 
|POLY 6             |        P=0.574N         P=0.529          P=0.284          P=0.266          (e)                              | 
|LOGISTIC REGRESSION|        (e)              P=0.572          P=0.330          P=0.320          (e)                              | 
|COCH-ARM / FISHERS |        P=0.483N         P=0.505          P=0.252          P=0.252          (e)                              | 
|ORDER RESTRICTED   |        P=0.338          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 10      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        28/53 (53%)      29/53 (55%)      22/53 (42%)      20/53 (38%)      10/53 (19%)                      | 
|POLY-3 RATE (b)    |        28/41.67         29/46.41         22/43.67         20/41.29         10/33.29                         | 
|POLY-3 PERCENT (g) |        67.2%            62.5%            50.4%            48.4%            30.0%                            | 
|TERMINAL (d)       |        11/16 (69%)      11/23 (48%)      12/24 (50%)      15/23 (65%)      4/8 (50%)                        | 
|FIRST INCIDENCE    |        416              416              592              490              633                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.026N*        P=0.239N         P=0.018N*        P=0.008N**       P=0.048N*                        | 
|POLY 3             |        P<0.001N**       P=0.401N         P=0.075N         P=0.052N         P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.500N         P=0.108N         P=0.057N         P<0.001N**                       | 
|POLY 6             |        P=0.003N**       P=0.288N         P=0.052N         P=0.056N         P=0.002N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.523N         P=0.052N         P=0.029N*        P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.500          P=0.165N         P=0.086N         P<0.001N**                       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        28/53 (53%)      29/53 (55%)      23/53 (43%)      20/53 (38%)      10/53 (19%)                      | 
|POLY-3 RATE (b)    |        28/41.67         29/46.41         23/43.77         20/41.29         10/33.29                         | 
|POLY-3 PERCENT (g) |        67.2%            62.5%            52.5%            48.4%            30.0%                            | 
|TERMINAL (d)       |        11/16 (69%)      11/23 (48%)      12/24 (50%)      15/23 (65%)      4/8 (50%)                        | 
|FIRST INCIDENCE    |        416              416              592              490              633                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.025N*        P=0.239N         P=0.026N*        P=0.008N**       P=0.048N*                        | 
|POLY 3             |        P<0.001N**       P=0.401N         P=0.110N         P=0.052N         P<0.001N**                       | 
|POLY 1.5           |        P<0.001N**       P=0.500N         P=0.151N         P=0.057N         P<0.001N**                       | 
|POLY 6             |        P=0.003N**       P=0.288N         P=0.078N         P=0.056N         P=0.002N**                       | 
|LOGISTIC REGRESSION|        P<0.001N**       P=0.523N         P=0.075N         P=0.029N*        P<0.001N**                       | 
|COCH-ARM / FISHERS |        P<0.001N**       P=0.500          P=0.218N         P=0.086N         P<0.001N**                       | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 11      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        2/53 (4%)        2/53 (4%)        3/53 (6%)        0/53 (0%)                        | 
|POLY-3 RATE (b)    |        1/36.39          2/40.22          2/42.04          3/40.39          0/32.33                          | 
|POLY-3 PERCENT (g) |        2.8%             5.0%             4.8%             7.4%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        1/24 (4%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        693              668              456              542              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.422N         P=0.588          P=0.595          P=0.371          P=0.605N                         | 
|POLY 3             |        P=0.363N         P=0.535          P=0.550          P=0.343          P=0.524N                         | 
|POLY 1.5           |        P=0.330N         P=0.522          P=0.529          P=0.328          P=0.513N                         | 
|POLY 6             |        P=0.412N         P=0.550          P=0.574          P=0.361          P=0.541N                         | 
|LOGISTIC REGRESSION|        P=0.300N         P=0.546          P=0.498          P=0.315          P=0.543N                         | 
|COCH-ARM / FISHERS |        P=0.287N         P=0.500          P=0.500          P=0.309          P=0.500N                         | 
|ORDER RESTRICTED   |        P=0.280N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        2/53 (4%)        2/53 (4%)        4/53 (8%)        0/53 (0%)                        | 
|POLY-3 RATE (b)    |        2/36.63          2/40.22          2/42.04          4/40.58          0/32.33                          | 
|POLY-3 PERCENT (g) |        5.5%             5.0%             4.8%             9.9%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        1/24 (4%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        666              668              456              542              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.362N         P=0.607N         P=0.595N         P=0.427          P=0.327N                         | 
|POLY 3             |        P=0.320N         P=0.661N         P=0.644N         P=0.384          P=0.265N                         | 
|POLY 1.5           |        P=0.281N         P=0.672N         P=0.666N         P=0.366          P=0.252N                         | 
|POLY 6             |        P=0.379N         P=0.648N         P=0.621N         P=0.407          P=0.288N                         | 
|LOGISTIC REGRESSION|        P=0.249N         P=0.655N         P=0.693N         P=0.356          P=0.271N                         | 
|COCH-ARM / FISHERS |        P=0.232N         P=0.691N         P=0.691N         P=0.339          P=0.248N                         | 
|ORDER RESTRICTED   |        P=0.226N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 12      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        17/53 (32%)      10/53 (19%)      18/51 (35%)      9/52 (17%)       5/51 (10%)                       | 
|POLY-3 RATE (b)    |        17/38.32         10/40.85         18/42.15         9/40.48          5/34.12                          | 
|POLY-3 PERCENT (g) |        44.4%            24.5%            42.7%            22.2%            14.7%                            | 
|TERMINAL (d)       |        7/16 (44%)       6/23 (26%)       10/24 (42%)      6/23 (26%)       0/8 (0%)                         | 
|FIRST INCIDENCE    |        568              627              617              548              542                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.070N         P=0.020N*        P=0.241N         P=0.012N*        P=0.067N                         | 
|POLY 3             |        P=0.005N**       P=0.045N*        P=0.531N         P=0.027N*        P=0.004N**                       | 
|POLY 1.5           |        P=0.004N**       P=0.057N         P=0.557          P=0.036N*        P=0.004N**                       | 
|POLY 6             |        P=0.009N**       P=0.037N*        P=0.433N         P=0.021N*        P=0.006N**                       | 
|LOGISTIC REGRESSION|        P=0.009N**       P=0.032N*        P=0.443N         P=0.023N*        P=0.009N**                       | 
|COCH-ARM / FISHERS |        P=0.004N**       P=0.090N         P=0.444          P=0.063N         P=0.005N**                       | 
|ORDER RESTRICTED   |        P=0.005N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        0/53 (0%)        0/51 (0%)        1/52 (2%)        1/51 (2%)                        | 
|POLY-3 RATE (b)    |        2/36.76          0/39.99          0/40.30          1/39.36          1/32.48                          | 
|POLY-3 PERCENT (g) |        5.4%             0.0%             0.0%             2.5%             3.1%                             | 
|TERMINAL (d)       |        1/16 (6%)        0/23 (0%)        0/24 (0%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        575              ---              ---              729 (T)          674                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.521          P=0.195N         P=0.181N         P=0.408N         P=0.606N                         | 
|POLY 3             |        P=0.563          P=0.218N         P=0.217N         P=0.476N         P=0.543N                         | 
|POLY 1.5           |        P=0.589          P=0.225N         P=0.229N         P=0.486N         P=0.526N                         | 
|POLY 6             |        P=0.528          P=0.211N         P=0.203N         P=0.466N         P=0.572N                         | 
|LOGISTIC REGRESSION|        P=0.596          P=0.228N         P=0.235N         P=0.475N         P=0.537N                         | 
|COCH-ARM / FISHERS |        P=0.621          P=0.248N         P=0.257N         P=0.507N         P=0.515N                         | 
|ORDER RESTRICTED   |        P=0.216N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 13      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      10/53 (19%)      18/51 (35%)      10/52 (19%)      6/51 (12%)                       | 
|POLY-3 RATE (b)    |        18/38.83         10/40.85         18/42.15         10/40.48         6/34.33                          | 
|POLY-3 PERCENT (g) |        46.4%            24.5%            42.7%            24.7%            17.5%                            | 
|TERMINAL (d)       |        7/16 (44%)       6/23 (26%)       10/24 (42%)      7/23 (30%)       0/8 (0%)                         | 
|FIRST INCIDENCE    |        568              627              617              548              542                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.115N         P=0.013N*        P=0.186N         P=0.012N*        P=0.081N                         | 
|POLY 3             |        P=0.011N*        P=0.029N*        P=0.457N         P=0.031N*        P=0.006N**                       | 
|POLY 1.5           |        P=0.008N**       P=0.037N*        P=0.540N         P=0.040N*        P=0.005N**                       | 
|POLY 6             |        P=0.018N*        P=0.025N*        P=0.370N         P=0.026N*        P=0.009N**                       | 
|LOGISTIC REGRESSION|        P=0.017N*        P=0.021N*        P=0.377N         P=0.026N*        P=0.011N*                        | 
|COCH-ARM / FISHERS |        P=0.007N**       P=0.061N         P=0.525          P=0.068N         P=0.006N**                       | 
|ORDER RESTRICTED   |        P=0.006N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/51 (4%)        0/52 (0%)        1/51 (2%)                        | 
|POLY-3 RATE (b)    |        0/36.25          0/39.99          2/40.56          0/39.36          1/32.43                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.9%             0.0%             3.1%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        1/24 (4%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              659              ---              689                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.298          (e)              P=0.317          (e)              P=0.424                          | 
|POLY 3             |        P=0.399          (e)              P=0.263          (e)              P=0.478                          | 
|POLY 1.5           |        P=0.413          (e)              P=0.247          (e)              P=0.487                          | 
|POLY 6             |        P=0.376          (e)              P=0.283          (e)              P=0.463                          | 
|LOGISTIC REGRESSION|        P=0.375          (e)              P=0.265          (e)              P=0.460                          | 
|COCH-ARM / FISHERS |        P=0.425          (e)              P=0.238          (e)              P=0.490                          | 
|ORDER RESTRICTED   |        P=0.284          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 14      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        1/53 (2%)        2/53 (4%)        2/53 (4%)        1/53 (2%)                        | 
|POLY-3 RATE (b)    |        1/36.52          1/39.99          2/41.29          2/40.11          1/32.88                          | 
|POLY-3 PERCENT (g) |        2.7%             2.5%             4.8%             5.0%             3.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        1/23 (4%)        2/24 (8%)        1/23 (4%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        658              729 (T)          729 (T)          505              562                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.465          P=0.702N         P=0.621          P=0.577          P=0.726                          | 
|POLY 3             |        P=0.549          P=0.741N         P=0.543          P=0.533          P=0.738                          | 
|POLY 1.5           |        P=0.582          P=0.748N         P=0.524          P=0.521          P=0.748                          | 
|POLY 6             |        P=0.501          P=0.733N         P=0.563          P=0.547          P=0.720                          | 
|LOGISTIC REGRESSION|        P=0.596          P=0.736N         P=0.572          P=0.501          P=0.761                          | 
|COCH-ARM / FISHERS |        P=0.601N         P=0.752N         P=0.500          P=0.500          P=0.752N                         | 
|ORDER RESTRICTED   |        P=0.608          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Leiomyoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/53 (0%)        0/53 (0%)        2/53 (4%)        0/53 (0%)        0/53 (0%)                        | 
|POLY-3 RATE (b)    |        0/36.25          0/39.99          2/41.55          0/39.44          0/32.33                          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             4.8%             0.0%             0.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        1/24 (4%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              659              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.607N         (e)              P=0.317          (e)              (e)                              | 
|POLY 3             |        P=0.503N         (e)              P=0.268          (e)              (e)                              | 
|POLY 1.5           |        P=0.502N         (e)              P=0.254          (e)              (e)                              | 
|POLY 6             |        P=0.504N         (e)              P=0.286          (e)              (e)                              | 
|LOGISTIC REGRESSION|        P=0.547N         (e)              P=0.271          (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.499N         (e)              P=0.248          (e)              (e)                              | 
|ORDER RESTRICTED   |        P=0.431          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 15      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        4/53 (8%)        1/53 (2%)        3/53 (6%)        3/53 (6%)        2/53 (4%)                        | 
|POLY-3 RATE (b)    |        4/36.88          1/39.99          3/41.39          3/39.57          2/33.09                          | 
|POLY-3 PERCENT (g) |        10.9%            2.5%             7.3%             7.6%             6.0%                             | 
|TERMINAL (d)       |        1/16 (6%)        1/23 (4%)        2/24 (8%)        2/23 (9%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        627              729 (T)          702              697              562                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.492          P=0.114N         P=0.333N         P=0.363N         P=0.489N                         | 
|POLY 3             |        P=0.512N         P=0.153N         P=0.437N         P=0.461N         P=0.387N                         | 
|POLY 1.5           |        P=0.480N         P=0.161N         P=0.464N         P=0.474N         P=0.364N                         | 
|POLY 6             |        P=0.552N         P=0.145N         P=0.408N         P=0.447N         P=0.424N                         | 
|LOGISTIC REGRESSION|        P=0.551N         P=0.142N         P=0.398N         P=0.433N         P=0.388N                         | 
|COCH-ARM / FISHERS |        P=0.431N         P=0.181N         P=0.500N         P=0.500N         P=0.339N                         | 
|ORDER RESTRICTED   |        P=0.373N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Schwannoma Malignant                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/53 (2%)        0/53 (0%)        1/53 (2%)        2/53 (4%)        1/53 (2%)                        | 
|POLY-3 RATE (b)    |        1/36.84          0/39.99          1/41.70          2/40.01          1/33.16                          | 
|POLY-3 PERCENT (g) |        2.7%             0.0%             2.4%             5.0%             3.0%                             | 
|TERMINAL (d)       |        0/16 (0%)        0/23 (0%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        540              ---              609              619              409                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.385          P=0.472N         P=0.725N         P=0.535          P=0.753                          | 
|POLY 3             |        P=0.372          P=0.484N         P=0.733N         P=0.529          P=0.738                          | 
|POLY 1.5           |        P=0.407          P=0.489N         P=0.745N         P=0.518          P=0.749                          | 
|POLY 6             |        P=0.323          P=0.477N         P=0.718N         P=0.543          P=0.719                          | 
|LOGISTIC REGRESSION|        P=0.490          P=0.533N         P=0.751          P=0.493          P=0.733N                         | 
|COCH-ARM / FISHERS |        P=0.455          P=0.500N         P=0.752N         P=0.500          P=0.752N                         | 
|ORDER RESTRICTED   |        P=0.423          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 16      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        | 
|     NOS, or Undifferentiated Cell Type                                                                                          | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/53 (4%)        1/53 (2%)        0/53 (0%)        1/53 (2%)        2/53 (4%)                        | 
|POLY-3 RATE (b)    |        2/36.91          1/39.99          0/41.29          1/39.84          2/33.40                          | 
|POLY-3 PERCENT (g) |        5.4%             2.5%             0.0%             2.5%             6.0%                             | 
|TERMINAL (d)       |        1/16 (6%)        1/23 (4%)        0/24 (0%)        0/23 (0%)        0/8 (0%)                         | 
|FIRST INCIDENCE    |        508              729 (T)          ---              616              387                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.312          P=0.406N         P=0.183N         P=0.438N         P=0.615                          | 
|POLY 3             |        P=0.379          P=0.472N         P=0.213N         P=0.473N         P=0.659                          | 
|POLY 1.5           |        P=0.399          P=0.481N         P=0.223N         P=0.483N         P=0.675                          | 
|POLY 6             |        P=0.354          P=0.461N         P=0.201N         P=0.461N         P=0.632                          | 
|LOGISTIC REGRESSION|        P=0.444          P=0.484N         P=0.240N         P=0.505N         P=0.684N                         | 
|COCH-ARM / FISHERS |        P=0.429          P=0.500N         P=0.248N         P=0.500N         P=0.691N                         | 
|ORDER RESTRICTED   |        P=0.372          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        45/53 (85%)      43/53 (81%)      46/53 (87%)      43/53 (81%)      39/53 (74%)                      | 
|POLY-3 RATE (b)    |        45/48.33         43/49.69         46/50.24         43/47.21         39/43.27                         | 
|POLY-3 PERCENT (g) |        93.1%            86.5%            91.6%            91.1%            90.1%                            | 
|TERMINAL (d)       |        14/16 (88%)      18/23 (78%)      22/24 (92%)      21/23 (91%)      8/8 (100%)                       | 
|FIRST INCIDENCE    |        176              362              263              333              409                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.037 *        P=0.082N         P=0.080N         P=0.066N         P=0.184                          | 
|POLY 3             |        P=0.550N         P=0.211N         P=0.539N         P=0.506N         P=0.433N                         | 
|POLY 1.5           |        P=0.289N         P=0.267N         P=0.645N         P=0.445N         P=0.256N                         | 
|POLY 6             |        P=0.317          P=0.182N         P=0.473N         P=0.580N         P=0.718N                         | 
|LOGISTIC REGRESSION|        P=0.174N         P=0.268N         P=0.610          P=0.230N         P=0.167N                         | 
|COCH-ARM / FISHERS |        P=0.064N         P=0.398N         P=0.500          P=0.398N         P=0.115N                         | 
|ORDER RESTRICTED   |        P=0.479N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/29/03                           EXPERIMENT: 96007 TEST: 04                                            Page 17      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX                  
                                         Terminal Sacrifice at 105 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        18/53 (34%)      14/53 (26%)      19/53 (36%)      21/53 (40%)      21/53 (40%)                      | 
|POLY-3 RATE (b)    |        18/43.25         14/45.06         19/44.70         21/45.77         21/41.51                         | 
|POLY-3 PERCENT (g) |        41.6%            31.1%            42.5%            45.9%            50.6%                            | 
|TERMINAL (d)       |        5/16 (31%)       7/23 (30%)       8/24 (33%)       9/23 (39%)       1/8 (13%)                        | 
|FIRST INCIDENCE    |        218              227              203              276              312                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.011 *        P=0.126N         P=0.307N         P=0.508N         P=0.152                          | 
|POLY 3             |        P=0.080          P=0.204N         P=0.553          P=0.423          P=0.264                          | 
|POLY 1.5           |        P=0.098          P=0.216N         P=0.524          P=0.394          P=0.289                          | 
|POLY 6             |        P=0.066          P=0.205N         P=0.585          P=0.455          P=0.233                          | 
|LOGISTIC REGRESSION|        P=0.197          P=0.354N         P=0.489          P=0.295          P=0.380                          | 
|COCH-ARM / FISHERS |        P=0.151          P=0.263N         P=0.500          P=0.344          P=0.344                          | 
|ORDER RESTRICTED   |        P=0.142          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                                | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        51/53 (96%)      46/53 (87%)      50/53 (94%)      50/53 (94%)      45/53 (85%)                      | 
|POLY-3 RATE (b)    |        51/53.00         46/51.78         50/52.00         50/51.35         45/47.10                         | 
|POLY-3 PERCENT (g) |        96.2%            88.8%            96.2%            97.4%            95.6%                            | 
|TERMINAL (d)       |        14/16 (88%)      18/23 (78%)      22/24 (92%)      22/23 (96%)      8/8 (100%)                       | 
|FIRST INCIDENCE    |        176              227              203              276              312                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.022 *        P=0.045N*        P=0.054N         P=0.094N         P=0.196                          | 
|POLY 3             |        P=0.319          P=0.136N         P=0.686N         P=0.591          P=0.649N                         | 
|POLY 1.5           |        P=0.574N         P=0.109N         P=0.684N         P=0.679          P=0.348N                         | 
|POLY 6             |        P=0.153          P=0.172N         P=0.686N         P=0.531          P=0.557                          | 
|LOGISTIC REGRESSION|        P=0.139N         P=0.105N         P=0.480N         P=0.478N         P=0.064N                         | 
|COCH-ARM / FISHERS |        P=0.081N         P=0.080N         P=0.500N         P=0.500N         P=0.046N*                        | 
|ORDER RESTRICTED   |        P=0.299          (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).