Share This:
https://ntp.niehs.nih.gov/go/18437

TDMS Study 96021-01 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 06/05/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 10:51:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        31 WEEK SSAC FINAL#1                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     032299 032399                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 002    10 UG/KG                                                                      
                                       INCLUDE 003    100     UG/KG                                                                 
                                       INCLUDE 004    300     UG/KG                                                                 
                                       INCLUDE 005    1000    UG/KG                                                                 
                                       INCLUDE 006    3000    UG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 06/05/03       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 10:51:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TOXIC EQUIVALENCY FACTOR EVALUATION (                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Liver: Hepatocyte                      Hypertrophy                                                                                  
Uterus                                 Inflammation                                                                                 
===============================================================                                                                     
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (        
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|POLY-3 RATE (b)    |        3/3.07           0/0.00           0/0.00           0/0.00           0/0.00           2/2.08          | 
|POLY-3 PERCENT (g) |        97.9%            0.0%             0.0%             0.0%             0.0%             96.4%           | 
|INT SACRIFICE 1 (c)|        3/10 (30%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              ---              ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.433N         P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.354N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.367N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.353N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.432N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 
|POLY-3 RATE (b)    |        1/1.09           0/0.00           0/0.00           0/0.00           0/0.00           3/3.07          | 
|POLY-3 PERCENT (g) |        92.2%            0.0%             0.0%             0.0%             0.0%             97.9%           | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         3/10 (30%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              ---              ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.234          P=1.000N         P=1.000N         P=1.000N         P=1.000N         P=0.293         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.153         | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.166         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.152         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.228          P=1.000          P=1.000          P=1.000          P=1.000          P=0.291         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        9/9.01           10/10.00         10/10.00         9/9.01           10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        99.9%            100.0%           100.0%           99.9%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        9/10 (90%)       10/10 (100%)     10/10 (100%)     9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          211 (I)          211 (I)          211 (I)          211 (I)          211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.455          P=0.500          P=0.500          P=0.766          P=0.500          P=0.500         | 
|POLY 3             |        P=0.459          P=0.484          P=0.484          P=0.741          P=0.484          P=0.484         | 
|POLY 1.5           |        P=0.457          P=0.483          P=0.483          P=0.741          P=0.483          P=0.483         | 
|POLY 6             |        P=0.463          P=0.489          P=0.489          P=0.744          P=0.489          P=0.489         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.454          P=0.500          P=0.500          P=0.763N         P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.183          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       1/10 (10%)       4/10 (40%)       2/10 (20%)       2/10 (20%)       1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/2.08           1/1.09           4/4.06           2/2.08           2/2.08           1/1.09          | 
|POLY-3 PERCENT (g) |        96.4%            92.2%            98.6%            96.4%            96.4%            92.2%           | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       1/10 (10%)       4/10 (40%)       2/10 (20%)       2/10 (20%)       1/10 (10%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          211 (I)          211 (I)          211 (I)          211 (I)          211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.294N         P=0.500N         P=0.317          P=0.707          P=0.707          P=0.500N        | 
|POLY 3             |        P=0.209N         P=0.301N         P=0.204          P=0.544          P=0.544          P=0.301N        | 
|POLY 1.5           |        P=0.217N         P=0.319N         P=0.214          P=0.559          P=0.559          P=0.319N        | 
|POLY 6             |        P=0.208N         P=0.299N         P=0.203          P=0.543          P=0.543          P=0.299N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.292N         P=0.500N         P=0.314          P=0.709N         P=0.709N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.392N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       1/10 (10%)       0/10 (0%)        7/10 (70%)       9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        1/1.09           1/1.09           0/0.09           7/7.03           9/9.01           10/10.00        | 
|POLY-3 PERCENT (g) |        92.2%            92.2%            0.0%             99.6%            99.9%            100.0%          | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       1/10 (10%)       0/10 (0%)        7/10 (70%)       9/10 (90%)       10/10 (100%)    | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          211 (I)          ---              211 (I)          211 (I)          211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.766          P=0.500N         P=0.013 *        P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.531          P=0.161N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.553          P=0.189N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.529          P=0.159N         P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        P<0.001 **       (e)              (e)              P=0.011 *        P<0.001 **       (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.763N         P=0.500N         P=0.010 *        P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/10 (70%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         7/10 (70%)      | 
|POLY-3 RATE (b)    |        7/7.03           0/0.00           0/0.00           0/0.00           0/0.00           7/7.03          | 
|POLY-3 PERCENT (g) |        99.6%            0.0%             0.0%             0.0%             0.0%             99.6%           | 
|INT SACRIFICE 1 (c)|        7/10 (70%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         7/10 (70%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              ---              ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.624          P=1.000N         P=1.000          P=1.000N         P=1.000          P=0.683         | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.629N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.633         | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.631N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.628          P=1.000          P=1.000          P=1.000          P=1.000          P=0.686N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Spleen                                                                                                                           | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         0/0.00           0/0.00           0/0.00           0/0.00           10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           0.0%             0.0%             0.0%             0.0%             100.0%          | 
|INT SACRIFICE 1 (c)|        10/10 (100%)     0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         10/10 (100%)    | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              ---              ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|POLY-3 RATE (b)    |        1/1.09           2/2.08           0/0.09           1/1.09           0/0.09           0/0.09          | 
|POLY-3 PERCENT (g) |        92.2%            96.4%            0.0%             92.2%            0.0%             0.0%            | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        0/10 (0%)       | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          211 (I)          ---              211 (I)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.218N         P=0.500          P=0.500N         P=0.766          P=0.500N         P=0.500N        | 
|POLY 3             |        P=0.105N         P=0.301          P=0.161N         P=0.531          P=0.161N         P=0.161N        | 
|POLY 1.5           |        P=0.112N         P=0.319          P=0.189N         P=0.553          P=0.189N         P=0.189N        | 
|POLY 6             |        P=0.104N         P=0.299          P=0.159N         P=0.529          P=0.159N         P=0.159N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.216N         P=0.500          P=0.500N         P=0.763N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.331N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       1/10 (10%)       1/10 (10%)       2/10 (20%)       0/10 (0%)        1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/2.08           1/1.09           1/1.09           2/2.08           0/0.09           1/1.09          | 
|POLY-3 PERCENT (g) |        96.4%            92.2%            92.2%            96.4%            0.0%             92.2%           | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       1/10 (10%)       1/10 (10%)       2/10 (20%)       0/10 (0%)        1/10 (10%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          211 (I)          211 (I)          211 (I)          ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.436N         P=0.500N         P=0.500N         P=0.707          P=0.234N         P=0.500N        | 
|POLY 3             |        P=0.318N         P=0.301N         P=0.301N         P=0.544          P=0.068N         P=0.301N        | 
|POLY 1.5           |        P=0.327N         P=0.319N         P=0.319N         P=0.559          P=0.079N         P=0.319N        | 
|POLY 6             |        P=0.317N         P=0.299N         P=0.299N         P=0.543          P=0.067N         P=0.299N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.435N         P=0.500N         P=0.500N         P=0.709N         P=0.237N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.131N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         3/10 (30%)      | 
|POLY-3 RATE (b)    |        1/1.09           0/0.00           0/0.00           1/1.00           0/0.00           3/3.07          | 
|POLY-3 PERCENT (g) |        92.2%            0.0%             0.0%             100.0%           0.0%             97.9%           | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         3/10 (30%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              211 (I)          ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.357          P=1.000N         P=1.000N         P=0.205          P=1.000N         P=0.293         | 
|POLY 3             |        (e)              (e)              (e)              P=0.009 **       (e)              P=0.153         | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.020 *        (e)              P=0.166         | 
|POLY 6             |        (e)              (e)              (e)              P=0.008 **       (e)              P=0.152         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.354          P=1.000          P=1.000          P=0.182          P=1.000          P=0.291         | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/05/03                           EXPERIMENT: 96021 TEST: 01                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -       TOXIC EQUIVALENCY FACTOR EVALUATION (         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        7/10 (70%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         5/10 (50%)      | 
|POLY-3 RATE (b)    |        7/7.03           0/0.00           0/0.00           1/1.00           0/0.00           5/5.05          | 
|POLY-3 PERCENT (g) |        99.6%            0.0%             0.0%             100.0%           0.0%             99.1%           | 
|INT SACRIFICE 1 (c)|        7/10 (70%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         5/10 (50%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              211 (I)          ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.234N         P=1.000N         P=1.000N         P=0.695          P=1.000N         P=0.328N        | 
|POLY 3             |        (e)              (e)              (e)              P=0.674          (e)              P=0.265N        | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.675          (e)              P=0.271N        | 
|POLY 6             |        (e)              (e)              (e)              P=0.677          (e)              P=0.266N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P=0.324N        | 
|COCH-ARM / FISHERS |        P=0.229N         P=1.000          P=1.000          P=0.727          P=1.000          P=0.325N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 UG/KG          10 UG/KG         100              300              1000             3000            | 
|                   |                                          UG/KG            UG/KG            UG/KG            UG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/2.08           0/0.00           0/0.00           1/1.00           0/0.00           1/1.09          | 
|POLY-3 PERCENT (g) |        96.4%            0.0%             0.0%             100.0%           0.0%             92.2%           | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       0/0 (0%)         0/0 (0%)         1/1 (100%)       0/0 (0%)         1/10 (10%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        211 (I)          ---              ---              211 (I)          ---              211 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.296N         P=1.000N         P=1.000          P=0.305          P=1.000          P=0.500N        | 
|POLY 3             |        (e)              (e)              (e)              P=0.105          (e)              P=0.301N        | 
|POLY 1.5           |        (e)              (e)              (e)              P=0.142          (e)              P=0.319N        | 
|POLY 6             |        (e)              (e)              (e)              P=0.102          (e)              P=0.299N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.291N         P=1.000          P=1.000          P=0.273          P=1.000          P=0.500N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).