National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5917

TDMS Study 96007-04 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 04/22/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 10:46:55       
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    
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        53 WEEK SSAC/FINAL#1                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     061699 061999                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    TERT.MIXCONTROL                                                               
                                       INCLUDE 002    TERT.MIXTEQ=10                                                                
                                       INCLUDE 003    TERT.MIXTEQ=22                                                                
                                       INCLUDE 004    TERT.MIXTEQ=46                                                                
                                       INCLUDE 005    TERT.MIXTEQ=100                                                               
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 04/22/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 10:46:55       
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                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Degeneration Cystic                                                                          
                                       Hypertrophy                                                                                  
Liver                                  Fatty Change Diffuse                                                                         
                                       Fatty Change Focal                                                                           
                                       Mixed Cell Focus                                                                             
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Bile Duct                       Hyperplasia                                                                                  
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Lung: Alveolar Epithelium              Metaplasia Bronchiolar                                                                       
Mammary Gland                          Cyst                                                                                         
Pancreas: Acinus                       Vacuolization Cytoplasmic                                                                    
Thymus                                 Atrophy                                                                                      
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX        
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Degeneration Cystic                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/8 (13%)        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|POLY-3 RATE (b)    |        1/1.34           0/0.39           0/0.39           0/0.39           2/2.30                           | 
|POLY-3 PERCENT (g) |        74.4%            0.0%             0.0%             0.0%             87.1%                            | 
|INT SACRIFICE 1 (c)|        1/8 (12.5%)      0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          ---              ---              ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.136          P=0.500N         P=0.500N         P=0.500N         P=0.500                          | 
|POLY 3             |        P=0.066          P=0.173N         P=0.173N         P=0.173N         P=0.314                          | 
|POLY 1.5           |        P=0.081          P=0.228N         P=0.228N         P=0.228N         P=0.348                          | 
|POLY 6             |        P=0.067          P=0.159N         P=0.159N         P=0.159N         P=0.304                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.133          P=0.500N         P=0.500N         P=0.500N         P=0.500                          | 
|ORDER RESTRICTED   |        P=0.048 *        (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                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         2/8 (25%)        1/8 (13%)        2/8 (25%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           2/2.30           1/1.34           2/2.30                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             87.1%            74.4%            87.1%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         2/8 (25%)        1/8 (12.5%)      2/8 (25%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.130          (e)              P=0.232          P=0.500          P=0.232                          | 
|POLY 3             |        P=0.081          (e)              P=0.069          P=0.173          P=0.069                          | 
|POLY 1.5           |        P=0.090          (e)              P=0.093          P=0.228          P=0.093                          | 
|POLY 6             |        P=0.079          (e)              P=0.064          P=0.159          P=0.064                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.127          (e)              P=0.233          P=0.500          P=0.233                          | 
|ORDER RESTRICTED   |        P=0.182          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/8 (38%)        7/8 (88%)        5/8 (63%)        3/8 (38%)        5/8 (63%)                        | 
|POLY-3 RATE (b)    |        3/3.25           7/7.05           5/5.15           3/3.25           5/5.15                           | 
|POLY-3 PERCENT (g) |        92.4%            99.3%            97.1%            92.4%            97.1%                            | 
|INT SACRIFICE 1 (c)|        3/8 (37.5%)      7/8 (87.5%)      5/8 (62.5%)      3/8 (37.5%)      5/8 (62.5%)                      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.592N         P=0.067          P=0.314          P=0.691          P=0.314                          | 
|POLY 3             |        P=0.565N         P=0.024 *        P=0.231          P=0.578          P=0.231                          | 
|POLY 1.5           |        P=0.570N         P=0.028 *        P=0.247          P=0.598          P=0.247                          | 
|POLY 6             |        P=0.563N         P=0.023 *        P=0.227          P=0.573          P=0.227                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.593N         P=0.059          P=0.310          P=0.696N         P=0.310                          | 
|ORDER RESTRICTED   |        P=0.216          (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                                                                                                                            | 
|     Cholangiofibrosis                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)        1/8 (13%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           2/2.30           1/1.34                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             87.1%            74.4%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)        1/8 (12.5%)                      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.167          (e)              (e)              P=0.232          P=0.500                          | 
|POLY 3             |        P=0.087          (e)              (e)              P=0.069          P=0.173                          | 
|POLY 1.5           |        P=0.097          (e)              (e)              P=0.093          P=0.228                          | 
|POLY 6             |        P=0.084          (e)              (e)              P=0.064          P=0.159                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.164          (e)              (e)              P=0.233          P=0.500                          | 
|ORDER RESTRICTED   |        P=0.257          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           0/0.39           2/2.30                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             87.1%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.020 *        (e)              (e)              (e)              P=0.232                          | 
|POLY 3             |        P=0.003 **       (e)              (e)              (e)              P=0.069                          | 
|POLY 1.5           |        P=0.006 **       (e)              (e)              (e)              P=0.093                          | 
|POLY 6             |        P=0.003 **       (e)              (e)              (e)              P=0.064                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.019 *        (e)              (e)              (e)              P=0.233                          | 
|ORDER RESTRICTED   |        P=0.216          (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                                                                                                                            | 
|     Fatty Change Focal                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         3/8 (38%)        4/8 (50%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           3/3.25           4/4.20                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             92.4%            95.3%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         3/8 (37.5%)      4/8 (50%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.107          P=0.047 *                        | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.022 *        P=0.005 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.031 *        P=0.007 **                       | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.020 *        P=0.004 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.100          P=0.038 *                        | 
|ORDER RESTRICTED   |        P=0.060          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/8 (100%)       8/8 (100%)       8/8 (100%)       8/8 (100%)       8/8 (100%)                       | 
|POLY-3 RATE (b)    |        8/8.00           8/8.00           8/8.00           8/8.00           8/8.00                           | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           100.0%           100.0%                           | 
|INT SACRIFICE 1 (c)|        8/8 (100%)       8/8 (100%)       8/8 (100%)       8/8 (100%)       8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (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                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/8 (38%)        4/8 (50%)        7/8 (88%)        6/8 (75%)        7/8 (88%)                        | 
|POLY-3 RATE (b)    |        3/3.25           4/4.20           7/7.05           6/6.10           7/7.05                           | 
|POLY-3 PERCENT (g) |        92.4%            95.3%            99.3%            98.4%            99.3%                            | 
|INT SACRIFICE 1 (c)|        3/8 (37.5%)      4/8 (50%)        7/8 (87.5%)      6/8 (75%)        7/8 (87.5%)                      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.045 *        P=0.500          P=0.067          P=0.165          P=0.067                          | 
|POLY 3             |        P=0.035 *        P=0.398          P=0.024 *        P=0.100          P=0.024 *                        | 
|POLY 1.5           |        P=0.035 *        P=0.416          P=0.028 *        P=0.111          P=0.028 *                        | 
|POLY 6             |        P=0.035 *        P=0.393          P=0.023 *        P=0.098          P=0.023 *                        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.043 *        P=0.500          P=0.059          P=0.157          P=0.059                          | 
|ORDER RESTRICTED   |        P=0.017 *        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         4/8 (50%)        8/8 (100%)       8/8 (100%)       8/8 (100%)                       | 
|POLY-3 RATE (b)    |        0/0.39           4/4.20           8/8.00           8/8.00           8/8.00                           | 
|POLY-3 PERCENT (g) |        0.0%             95.3%            100.0%           100.0%           100.0%                           | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         4/8 (50%)        8/8 (100%)       8/8 (100%)       8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.047 *        P<0.001 **       P<0.001 **       P<0.001 **                       | 
|POLY 3             |        P<0.001 **       P=0.005 **       P<0.001N**       P<0.001N**       P<0.001N**                       | 
|POLY 1.5           |        P<0.001 **       P=0.007 **       P<0.001N**       P<0.001N**       P<0.001N**                       | 
|POLY 6             |        P<0.001 **       P=0.004 **       P<0.001N**       P<0.001N**       P<0.001N**                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.038 *        P<0.001 **       P<0.001 **       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                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         3/8 (38%)        8/8 (100%)                       | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           3/3.25           8/8.00                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             92.4%            100.0%                           | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         3/8 (37.5%)      8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.107          P<0.001 **                       | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.022 *        P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.031 *        P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.020 *        P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.100          P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Bile Duct                                                                                                                 | 
|     Hyperplasia                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         0/8 (0%)         6/8 (75%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           0/0.39           6/6.10                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             98.4%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         0/8 (0%)         6/8 (75%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.006 **                       | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.003 **                       | 
|ORDER RESTRICTED   |        P=0.007 **       (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: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         5/8 (63%)        7/8 (88%)        8/8 (100%)       8/8 (100%)                       | 
|POLY-3 RATE (b)    |        0/0.39           5/5.15           7/7.05           8/8.00           8/8.00                           | 
|POLY-3 PERCENT (g) |        0.0%             97.1%            99.3%            100.0%           100.0%                           | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         5/8 (62.5%)      7/8 (87.5%)      8/8 (100%)       8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.018 *        P=0.002 **       P<0.001 **       P<0.001 **                       | 
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.013 *        P<0.001 **       P<0.001 **       P<0.001 **                       | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         3/8 (38%)        0/8 (0%)         8/8 (100%)                       | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           3/3.25           0/0.39           8/8.00                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             92.4%            0.0%             100.0%                           | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         3/8 (37.5%)      0/8 (0%)         8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              366 (I)          ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              P=0.107          (e)              P<0.001 **                       | 
|POLY 3             |        P<0.001 **       (e)              P=0.022 *        (e)              P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              P=0.031 *        (e)              P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              P=0.020 *        (e)              P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.100          (e)              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                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/8 (75%)        5/8 (63%)        5/8 (63%)        4/8 (50%)        6/8 (75%)                        | 
|POLY-3 RATE (b)    |        6/6.10           5/5.15           5/5.15           4/4.20           6/6.10                           | 
|POLY-3 PERCENT (g) |        98.4%            97.1%            97.1%            95.3%            98.4%                            | 
|INT SACRIFICE 1 (c)|        6/8 (75%)        5/8 (62.5%)      5/8 (62.5%)      4/8 (50%)        6/8 (75%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.531          P=0.500N         P=0.500N         P=0.309N         P=0.712                          | 
|POLY 3             |        P=0.512          P=0.439N         P=0.439N         P=0.243N         P=0.661                          | 
|POLY 1.5           |        P=0.515          P=0.450N         P=0.450N         P=0.255N         P=0.669                          | 
|POLY 6             |        P=0.511          P=0.437N         P=0.437N         P=0.240N         P=0.660                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.532          P=0.500N         P=0.500N         P=0.304N         P=0.715N                         | 
|ORDER RESTRICTED   |        P=0.523          (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung: Alveolar Epithelium                                                                                                        | 
|     Metaplasia Bronchiolar                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         1/8 (13%)        2/8 (25%)        4/8 (50%)        6/8 (75%)                        | 
|POLY-3 RATE (b)    |        0/0.39           1/1.34           2/2.30           4/4.20           6/6.10                           | 
|POLY-3 PERCENT (g) |        0.0%             74.4%            87.1%            95.3%            98.4%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         1/8 (12.5%)      2/8 (25%)        4/8 (50%)        6/8 (75%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P=0.232          P=0.047 *        P=0.006 **                       | 
|POLY 3             |        P<0.001 **       P=0.173          P=0.069          P=0.005 **       P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       P=0.228          P=0.093          P=0.007 **       P<0.001 **                       | 
|POLY 6             |        P<0.001 **       P=0.159          P=0.064          P=0.004 **       P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P=0.233          P=0.038 *        P=0.003 **                       | 
|ORDER RESTRICTED   |        P=0.011 *        (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                                                                                                                    | 
|     Cyst                                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/8 (38%)        0/1 (0%)         0/1 (0%)         0/1 (0%)         0/8 (0%)                         | 
|POLY-3 RATE (b)    |        3/3.25           0/0.05           0/0.05           0/0.05           0/0.39                           | 
|POLY-3 PERCENT (g) |        92.4%            0.0%             0.0%             0.0%             0.0%                             | 
|INT SACRIFICE 1 (c)|        3/8 (37.5%)      0/1 (0%)         0/1 (0%)         0/1 (0%)         0/8 (0%)                         | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          ---              ---              ---              ---                              | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.073N         P=0.638N         P=0.638N         P=0.638N         P=0.107N                         | 
|POLY 3             |        P=0.034N*        P=0.264N         P=0.264N         P=0.264N         P=0.022N*                        | 
|POLY 1.5           |        P=0.039N*        P=0.327N         P=0.327N         P=0.327N         P=0.031N*                        | 
|POLY 6             |        P=0.032N*        P=0.248N         P=0.248N         P=0.248N         P=0.020N*                        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.068N         P=0.667N         P=0.667N         P=0.667N         P=0.100N                         | 
|ORDER RESTRICTED   |        P=0.019N*        (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/8 (100%)       8/8 (100%)       8/8 (100%)       6/8 (75%)        8/8 (100%)                       | 
|POLY-3 RATE (b)    |        8/8.00           8/8.00           8/8.00           6/6.10           8/8.00                           | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           98.4%            100.0%                           | 
|INT SACRIFICE 1 (c)|        8/8 (100%)       8/8 (100%)       8/8 (100%)       6/8 (75%)        8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.550N         (e)              (e)              P=0.232N         (e)                              | 
|POLY 3             |        P=0.567N         (e)              (e)              P=0.191N         (e)                              | 
|POLY 1.5           |        P=0.564N         (e)              (e)              P=0.197N         (e)                              | 
|POLY 6             |        P=0.570N         (e)              (e)              P=0.191N         (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.551N         (e)              (e)              P=0.233N         (e)                              | 
|ORDER RESTRICTED   |        P=0.155N         (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: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)        7/8 (88%)                        | 
|POLY-3 RATE (b)    |        0/0.39           0/0.39           0/0.39           2/2.30           7/7.05                           | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             87.1%            99.3%                            | 
|INT SACRIFICE 1 (c)|        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)        7/8 (87.5%)                      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        ---              ---              ---              366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              P=0.232          P=0.002 **                       | 
|POLY 3             |        P<0.001 **       (e)              (e)              P=0.069          P<0.001 **                       | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              P=0.093          P<0.001 **                       | 
|POLY 6             |        P<0.001 **       (e)              (e)              P=0.064          P<0.001 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              P=0.233          P<0.001 **                       | 
|ORDER RESTRICTED   |        P=0.004 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 10      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/8 (100%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         8/8 (100%)                       | 
|POLY-3 RATE (b)    |        8/8.00           0/0.00           0/0.00           0/0.00           8/8.00                           | 
|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             100.0%                           | 
|INT SACRIFICE 1 (c)|        8/8 (100%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         8/8 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          ---              ---              ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)                              | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)                              | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)                              | 
|ORDER RESTRICTED   |        (e)              (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                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/8 (38%)        7/8 (88%)        8/8 (100%)       8/8 (100%)       6/6 (100%)                       | 
|POLY-3 RATE (b)    |        3/3.25           7/7.05           8/8.00           8/8.00           6/6.00                           | 
|POLY-3 PERCENT (g) |        92.4%            99.3%            100.0%           100.0%           100.0%                           | 
|INT SACRIFICE 1 (c)|        3/8 (37.5%)      7/8 (87.5%)      8/8 (100%)       8/8 (100%)       6/6 (100%)                       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.020 *        P=0.067          P=0.018 *        P=0.018 *        P=0.037 *                        | 
|POLY 3             |        P=0.004 **       P=0.024 *        P<0.001 **       P<0.001 **       P=0.005 **                       | 
|POLY 1.5           |        P=0.004 **       P=0.028 *        P<0.001 **       P<0.001 **       P=0.006 **                       | 
|POLY 6             |        P=0.004 **       P=0.023 *        P<0.001 **       P<0.001 **       P=0.005 **                       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.019 *        P=0.059          P=0.013 *        P=0.013 *        P=0.028 *                        | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 11      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      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                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/8 (25%)        2/8 (25%)        3/8 (38%)        3/8 (38%)        4/8 (50%)                        | 
|POLY-3 RATE (b)    |        2/2.30           2/2.30           3/3.25           3/3.25           4/4.20                           | 
|POLY-3 PERCENT (g) |        87.1%            87.1%            92.4%            92.4%            95.3%                            | 
|INT SACRIFICE 1 (c)|        2/8 (25%)        2/8 (25%)        3/8 (37.5%)      3/8 (37.5%)      4/8 (50%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.183          P=0.712          P=0.500          P=0.500          P=0.309                          | 
|POLY 3             |        P=0.161          P=0.562          P=0.366          P=0.366          P=0.204                          | 
|POLY 1.5           |        P=0.167          P=0.589          P=0.391          P=0.391          P=0.224                          | 
|POLY 6             |        P=0.160          P=0.555          P=0.360          P=0.360          P=0.199                          | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.180          P=0.715N         P=0.500          P=0.500          P=0.304                          | 
|ORDER RESTRICTED   |        P=0.316          (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                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/8 (100%)       8/8 (100%)       8/8 (100%)       6/8 (75%)        7/8 (88%)                        | 
|POLY-3 RATE (b)    |        8/8.00           8/8.00           8/8.00           6/6.10           7/7.05                           | 
|POLY-3 PERCENT (g) |        100.0%           100.0%           100.0%           98.4%            99.3%                            | 
|INT SACRIFICE 1 (c)|        8/8 (100%)       8/8 (100%)       8/8 (100%)       6/8 (75%)        7/8 (87.5%)                      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          366 (I)          366 (I)          366 (I)          366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.167N         (e)              (e)              P=0.232N         P=0.500N                         | 
|POLY 3             |        P=0.153N         (e)              (e)              P=0.191N         P=0.476N                         | 
|POLY 1.5           |        P=0.154N         (e)              (e)              P=0.197N         P=0.480N                         | 
|POLY 6             |        P=0.153N         (e)              (e)              P=0.191N         P=0.478N                         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.164N         (e)              (e)              P=0.233N         P=0.500N                         | 
|ORDER RESTRICTED   |        P=0.099N         (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/22/03                           EXPERIMENT: 96007 TEST: 04                                            Page 12      
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -   TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX         TERT.MIX                         | 
|                   |        CONTROL          TEQ=10           TEQ=22           TEQ=46           TEQ=100                          | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        6/8 (75%)        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|POLY-3 RATE (b)    |        6/6.10           0/0.39           0/0.39           0/0.39           2/2.30                           | 
|POLY-3 PERCENT (g) |        98.4%            0.0%             0.0%             0.0%             87.1%                            | 
|INT SACRIFICE 1 (c)|        6/8 (75%)        0/8 (0%)         0/8 (0%)         0/8 (0%)         2/8 (25%)                        | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)                         | 
|FIRST INCIDENCE    |        366 (I)          ---              ---              ---              366 (I)                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.264N         P=0.006N**       P=0.006N**       P=0.006N**       P=0.073N                         | 
|POLY 3             |        P=0.133N         P<0.001N**       P<0.001N**       P<0.001N**       P=0.024N*                        | 
|POLY 1.5           |        P=0.140N         P<0.001N**       P<0.001N**       P<0.001N**       P=0.029N*                        | 
|POLY 6             |        P=0.129N         P<0.001N**       P<0.001N**       P<0.001N**       P=0.023N*                        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)                              | 
|COCH-ARM / FISHERS |        P=0.261N         P=0.003N**       P=0.003N**       P=0.003N**       P=0.066N                         | 
|ORDER RESTRICTED   |        P<0.001N**       (e)              (e)              (e)              (e)                              | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.