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TDMS Study 96007-03 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:01:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            31 WEEK SSAC                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     123098 123198                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 002    3 NG/KG                                                                       
                                       INCLUDE 003    10 NG/KG                                                                      
                                       INCLUDE 004    22 NG/KG                                                                      
                                       INCLUDE 005    46 NG/KG                                                                      
                                       INCLUDE 006    100     NG/KG                                                                 
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 11/25/02       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 12:01:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION                                                                        
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Cortex                         Hypertrophy                                                                                  
Liver                                  Fatty Change Diffuse                                                                         
                                       Mixed Cell Focus                                                                             
                                       Pigmentation                                                                                 
                                       Toxic Hepatopathy                                                                            
Liver: Hepatocyte                      Hypertrophy                                                                                  
                                       Multinucleated                                                                               
Pancreas: Acinus                       Vacuolization Cytoplasmic                                                                    
Thymus                                 Atrophy                                                                                      
Thyroid Gland: Follicular Cell         Hypertrophy                                                                                  
Uterus                                 Metaplasia                                                                                   
Uterus: Endometrium                    Hyperplasia Cystic                                                                           
===============================================================                                                                     
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION         
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Cortex                                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       3/10 (30%)       3/10 (30%)       3/10 (30%)       3/10 (30%)      | 
|POLY-3 RATE (b)    |        0/0.10           2/2.08           3/3.07           3/3.07           3/3.07           3/3.07          | 
|POLY-3 PERCENT (g) |        0.0%             96.3%            97.8%            97.8%            97.8%            97.8%           | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        2/10 (20%)       3/10 (30%)       3/10 (30%)       3/10 (30%)       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    |        ---              213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.215          P=0.234          P=0.111          P=0.111          P=0.111          P=0.111         | 
|POLY 3             |        P=0.173          P=0.068          P=0.025 *        P=0.025 *        P=0.025 *        P=0.025 *       | 
|POLY 1.5           |        P=0.177          P=0.079          P=0.030 *        P=0.030 *        P=0.030 *        P=0.030 *       | 
|POLY 6             |        P=0.174          P=0.067          P=0.025 *        P=0.025 *        P=0.025 *        P=0.025 *       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.213          P=0.237          P=0.105          P=0.105          P=0.105          P=0.105         | 
|ORDER RESTRICTED   |        P=0.064          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Fatty Change Diffuse                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)      | 
|POLY-3 RATE (b)    |        0/0.10           0/0.10           0/0.10           0/0.10           0/0.10           6/6.04          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             99.4%           | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        6/10 (60%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.009 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.005 **      | 
|ORDER RESTRICTED   |        P=0.082          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Inflammation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        9/9.01           9/9.01           10/10.00         10/10.00         10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        99.9%            99.9%            100.0%           100.0%           100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        9/10 (90%)       9/10 (90%)       10/10 (100%)     10/10 (100%)     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    |        213 (I)          213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.267          P=0.766          P=0.500          P=0.500          P=0.500          P=0.500         | 
|POLY 3             |        P=0.271          P=0.741          P=0.484          P=0.484          P=0.484          P=0.484         | 
|POLY 1.5           |        P=0.270          P=0.741          P=0.483          P=0.483          P=0.483          P=0.483         | 
|POLY 6             |        P=0.274          P=0.744          P=0.489          P=0.489          P=0.489          P=0.489         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.265          P=0.763N         P=0.500          P=0.500          P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.183          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Mixed Cell Focus                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        3/10 (30%)       7/10 (70%)       4/10 (40%)       2/10 (20%)       4/10 (40%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        3/3.07           7/7.03           4/4.06           2/2.08           4/4.06           10/10.00        | 
|POLY-3 PERCENT (g) |        97.8%            99.6%            98.6%            96.3%            98.6%            100.0%          | 
|INT SACRIFICE 1 (c)|        3/10 (30%)       7/10 (70%)       4/10 (40%)       2/10 (20%)       4/10 (40%)       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    |        213 (I)          213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.004 **       P=0.095          P=0.500          P=0.500N         P=0.500          P=0.003 **      | 
|POLY 3             |        P<0.001 **       P=0.047 *        P=0.385          P=0.354N         P=0.385          P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.050          P=0.395          P=0.368N         P=0.395          P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.047 *        P=0.385          P=0.353N         P=0.385          P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              P=0.090          (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.004 **       P=0.089          P=0.500          P=0.500N         P=0.500          P=0.002 **      | 
|ORDER RESTRICTED   |        P=0.010 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Pigmentation                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       8/10 (80%)       9/10 (90%)       10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/0.10           1/1.09           8/8.02           9/9.01           10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             92.0%            99.8%            99.9%            100.0%           100.0%          | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        1/10 (10%)       8/10 (80%)       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    |        ---              213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.161          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 1.5           |        P<0.001 **       P=0.189          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001N**      | 
|POLY 6             |        P<0.001 **       P=0.159          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001N**      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500          P<0.001 **       P<0.001 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Toxic Hepatopathy                                                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/0.10           0/0.10           0/0.10           0/0.10           0/0.10           10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             100.0%          | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (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    |        ---              ---              ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 4       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        2/10 (20%)       3/10 (30%)       6/10 (60%)       9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/0.10           2/2.08           3/3.07           6/6.04           9/9.01           10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             96.3%            97.8%            99.4%            99.9%            100.0%          | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        2/10 (20%)       3/10 (30%)       6/10 (60%)       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    |        ---              213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.234          P=0.111          P=0.009 **       P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.068          P=0.025 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.079          P=0.030 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.067          P=0.025 *        P<0.001 **       P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.237          P=0.105          P=0.005 **       P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver: Hepatocyte                                                                                                                | 
|     Multinucleated                                                                                                              | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)       9/10 (90%)      | 
|POLY-3 RATE (b)    |        0/0.10           0/0.10           0/0.10           0/0.10           5/5.05           9/9.01          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             99.0%            99.9%           | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)       9/10 (90%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P=0.022 *        P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P=0.002 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P=0.016 *        P<0.001 **      | 
|ORDER RESTRICTED   |        P=0.002 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 5       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Infiltration Cellular Histiocyte                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       3/10 (30%)       1/10 (10%)       1/10 (10%)       0/10 (0%)        1/10 (10%)      | 
|POLY-3 RATE (b)    |        2/2.08           3/3.07           1/1.09           1/1.09           0/0.10           1/1.09          | 
|POLY-3 PERCENT (g) |        96.3%            97.8%            92.0%            92.0%            0.0%             92.0%           | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       3/10 (30%)       1/10 (10%)       1/10 (10%)       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    |        213 (I)          213 (I)          213 (I)          213 (I)          ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.213N         P=0.500          P=0.500N         P=0.500N         P=0.234N         P=0.500N        | 
|POLY 3             |        P=0.151N         P=0.354          P=0.301N         P=0.301N         P=0.068N         P=0.301N        | 
|POLY 1.5           |        P=0.155N         P=0.368          P=0.320N         P=0.320N         P=0.079N         P=0.320N        | 
|POLY 6             |        P=0.150N         P=0.353          P=0.299N         P=0.299N         P=0.067N         P=0.299N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.211N         P=0.500          P=0.500N         P=0.500N         P=0.237N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.078N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Ovary                                                                                                                            | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         7/10 (70%)      | 
|POLY-3 RATE (b)    |        9/9.01           0/0.00           0/0.00           0/0.00           0/0.00           7/7.03          | 
|POLY-3 PERCENT (g) |        99.9%            0.0%             0.0%             0.0%             0.0%             99.6%           | 
|INT SACRIFICE 1 (c)|        9/10 (90%)       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    |        213 (I)          ---              ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.213N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.293N        | 
|POLY 3             |        (e)              (e)              (e)              (e)              (e)              P=0.254N        | 
|POLY 1.5           |        (e)              (e)              (e)              (e)              (e)              P=0.257N        | 
|POLY 6             |        (e)              (e)              (e)              (e)              (e)              P=0.255N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.207N         P=1.000          P=1.000          P=1.000          P=1.000          P=0.291N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 6       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        1/10 (10%)       0/10 (0%)       | 
|POLY-3 RATE (b)    |        2/2.08           0/0.10           1/1.09           0/0.10           1/1.09           0/0.10          | 
|POLY-3 PERCENT (g) |        96.3%            0.0%             92.0%            0.0%             92.0%            0.0%            | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       0/10 (0%)        1/10 (10%)       0/10 (0%)        1/10 (10%)       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    |        213 (I)          ---              213 (I)          ---              213 (I)          ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.289N         P=0.234N         P=0.500N         P=0.234N         P=0.500N         P=0.234N        | 
|POLY 3             |        P=0.176N         P=0.068N         P=0.301N         P=0.068N         P=0.301N         P=0.068N        | 
|POLY 1.5           |        P=0.178N         P=0.079N         P=0.320N         P=0.079N         P=0.320N         P=0.079N        | 
|POLY 6             |        P=0.176N         P=0.067N         P=0.299N         P=0.067N         P=0.299N         P=0.067N        | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.287N         P=0.237N         P=0.500N         P=0.237N         P=0.500N         P=0.237N        | 
|ORDER RESTRICTED   |        P=0.322N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas: Acinus                                                                                                                 | 
|     Vacuolization Cytoplasmic                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        5/10 (50%)      | 
|POLY-3 RATE (b)    |        0/0.10           0/0.10           0/0.10           0/0.10           0/0.10           5/5.05          | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             0.0%             99.0%           | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (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    |        ---              ---              ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.022 *       | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.002 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              (e)              P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              (e)              P=0.016 *       | 
|ORDER RESTRICTED   |        P=0.151          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 7       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/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    |        213 (I)          ---              ---              ---              ---              213 (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 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thymus                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        2/10 (20%)       1/10 (10%)       5/10 (50%)       6/10 (60%)       7/10 (70%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        2/2.08           1/1.09           5/5.05           6/6.04           7/7.03           10/10.00        | 
|POLY-3 PERCENT (g) |        96.3%            92.0%            99.0%            99.4%            99.6%            100.0%          | 
|INT SACRIFICE 1 (c)|        2/10 (20%)       1/10 (10%)       5/10 (50%)       6/10 (60%)       7/10 (70%)       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    |        213 (I)          213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       P=0.500N         P=0.180          P=0.091          P=0.040 *        P<0.001 **      | 
|POLY 3             |        P<0.001 **       P=0.301N         P=0.099          P=0.038 *        P=0.010 *        P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       P=0.320N         P=0.106          P=0.041 *        P=0.011 *        P<0.001 **      | 
|POLY 6             |        P<0.001 **       P=0.299N         P=0.099          P=0.038 *        P=0.010 *        P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P<0.001 **       P=0.500N         P=0.175          P=0.085          P=0.035 *        P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 8       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: Follicular Cell                                                                                                   | 
|     Hypertrophy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        3/10 (30%)       3/10 (30%)       3/10 (30%)       4/10 (40%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        0/0.10           3/3.07           3/3.07           3/3.07           4/4.06           6/6.04          | 
|POLY-3 PERCENT (g) |        0.0%             97.8%            97.8%            97.8%            98.6%            99.4%           | 
|INT SACRIFICE 1 (c)|        0/10 (0%)        3/10 (30%)       3/10 (30%)       3/10 (30%)       4/10 (40%)       6/10 (60%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        ---              213 (I)          213 (I)          213 (I)          213 (I)          213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.011 *        P=0.111          P=0.111          P=0.111          P=0.051          P=0.009 **      | 
|POLY 3             |        P=0.007 **       P=0.025 *        P=0.025 *        P=0.025 *        P=0.007 **       P<0.001 **      | 
|POLY 1.5           |        P=0.007 **       P=0.030 *        P=0.030 *        P=0.030 *        P=0.009 **       P<0.001 **      | 
|POLY 6             |        P=0.007 **       P=0.025 *        P=0.025 *        P=0.025 *        P=0.007 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.011 *        P=0.105          P=0.105          P=0.105          P=0.043 *        P=0.005 **      | 
|ORDER RESTRICTED   |        P=0.016 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Metaplasia                                                                                                                  | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        8/10 (80%)       0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|POLY-3 RATE (b)    |        8/8.02           0/0.01           0/0.00           0/0.00           0/0.00           4/4.06          | 
|POLY-3 PERCENT (g) |        99.8%            0.0%             0.0%             0.0%             0.0%             98.6%           | 
|INT SACRIFICE 1 (c)|        8/10 (80%)       0/1 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         4/10 (40%)      | 
|TERMINAL (d)       |        0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)         0/0 (0%)        | 
|FIRST INCIDENCE    |        213 (I)          ---              ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.103N         P=0.305N         P=1.000N         P=1.000N         P=1.000N         P=0.091N        | 
|POLY 3             |        (e)              P=0.036N*        (e)              (e)              (e)              P=0.048N*       | 
|POLY 1.5           |        (e)              P=0.046N*        (e)              (e)              (e)              P=0.051N        | 
|POLY 6             |        (e)              P=0.035N*        (e)              (e)              (e)              P=0.048N*       | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.098N         P=0.273N         P=1.000          P=1.000          P=1.000          P=0.085N        | 
|ORDER RESTRICTED   |        (e)              (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  11/25/02                           EXPERIMENT: 96007 TEST: 03                                            Page 9       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -        TOXIC EQUIVALENCY FACTOR EVALUATION          
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 NG/KG          3 NG/KG          10 NG/KG         22 NG/KG         46 NG/KG         100             | 
|                   |                                                                                             NG/KG           | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus: Endometrium                                                                                                              | 
|     Hyperplasia Cystic                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/10 (10%)       1/1 (100%)       0/0 (0%)         0/0 (0%)         0/0 (0%)         2/10 (20%)      | 
|POLY-3 RATE (b)    |        1/1.09           1/1.00           0/0.00           0/0.00           0/0.00           2/2.08          | 
|POLY-3 PERCENT (g) |        92.0%            100.0%           0.0%             0.0%             0.0%             96.3%           | 
|INT SACRIFICE 1 (c)|        1/10 (10%)       1/1 (100%)       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    |        213 (I)          213 (I)          ---              ---              ---              213 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.565          P=0.205          P=1.000N         P=1.000N         P=1.000N         P=0.500         | 
|POLY 3             |        (e)              P=0.009 **       (e)              (e)              (e)              P=0.301         | 
|POLY 1.5           |        (e)              P=0.020 *        (e)              (e)              (e)              P=0.320         | 
|POLY 6             |        (e)              P=0.008 **       (e)              (e)              (e)              P=0.299         | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.567          P=0.182          P=1.000          P=1.000          P=1.000          P=0.500         | 
|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).