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TDMS Study 96022-02 Pathology Tables

                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                     DATE: 06/10/04       
EXPERIMENT: 96022 TEST: 02                                                                                     TIME: 09:49:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96022       
PATHOLOGIST: MISSING                                                                                           CAS: TEFPCBMIX       
Rats(SD)                                                                                                                            
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Brain                                                                              
                                                 Clitoral/Preputial Gland                                                           
                                                 Heart                                                                              
                                                 Islets, Pancreatic                                                                 
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Lung                                                                               
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Thymus                                                                             
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                        TEF EVALUATION (PCB MIXTURE;PCB 126/PCB 118)                     DATE: 06/10/04       
EXPERIMENT: 96022 TEST: 02                                                                                     TIME: 09:49:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96022       
PATHOLOGIST: MISSING                                                                                           CAS: TEFPCBMIX       
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF      TEF EVALUATION (PCB MIXTURE;PCB 126/P                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Liver                                  Cholangiocarcinoma                                                                           
                                       Hepatocellular Adenoma                                                                       
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma                                           
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                          
Lung                                   Cystic Keratinizing Epithelioma                                                              
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
Uterus                                 Polyp Stromal                                                                                
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 1       
                     Statistical Analysis of Primary Tumors in Rats(SD)        -       TEF EVALUATION (PCB MIXTURE;PCB 126/P        
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cholangiocarcinoma                                                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              19/50 (38%)                                       12/65 (18%)                  | 
|POLY-3 RATE (b)    |                              19/25.19                                          12/17.30                     | 
|POLY-3 PERCENT (g) |                              75.4%                                             69.4%                        | 
|TERMINAL (d)       |                              8/10 (80%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              303                                               294                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P=0.516N                     | 
|POLY 1.5           |                                                                                P=0.091N                     | 
|POLY 6             |                                                                                P=0.551                      | 
|LOGISTIC REGRESSION|                                                                                P=0.102                      | 
|COCH-ARM / FISHERS |                                                                                P=0.017N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Adenoma                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         5/65 (8%)                    | 
|POLY-3 RATE (b)    |                              1/21.77                                           5/13.16                      | 
|POLY-3 PERCENT (g) |                              4.6%                                              38.0%                        | 
|TERMINAL (d)       |                              0/10 (0%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              451                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.025 *                    | 
|POLY 3             |                                                                                P=0.038 *                    | 
|POLY 1.5           |                                                                                P=0.072                      | 
|POLY 6             |                                                                                P=0.027 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.156                      | 
|COCH-ARM / FISHERS |                                                                                P=0.176                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 2       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         5/65 (8%)                    | 
|POLY-3 RATE (b)    |                              1/21.77                                           5/13.16                      | 
|POLY-3 PERCENT (g) |                              4.6%                                              38.0%                        | 
|TERMINAL (d)       |                              0/10 (0%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              451                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.025 *                    | 
|POLY 3             |                                                                                P=0.038 *                    | 
|POLY 1.5           |                                                                                P=0.072                      | 
|POLY 6             |                                                                                P=0.027 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.156                      | 
|COCH-ARM / FISHERS |                                                                                P=0.176                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           | 
|     or Hepatoblastoma                                                                                                           | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/50 (2%)                                         5/65 (8%)                    | 
|POLY-3 RATE (b)    |                              1/21.77                                           5/13.16                      | 
|POLY-3 PERCENT (g) |                              4.6%                                              38.0%                        | 
|TERMINAL (d)       |                              0/10 (0%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              451                                               245                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.025 *                    | 
|POLY 3             |                                                                                P=0.038 *                    | 
|POLY 1.5           |                                                                                P=0.072                      | 
|POLY 6             |                                                                                P=0.027 *                    | 
|LOGISTIC REGRESSION|                                                                                P=0.156                      | 
|COCH-ARM / FISHERS |                                                                                P=0.176                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 3       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Lung                                                                                                                             | 
|     Cystic Keratinizing Epithelioma                                                                                             | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/50 (24%)                                       41/66 (62%)                  | 
|POLY-3 RATE (b)    |                              12/28.23                                          41/42.27                     | 
|POLY-3 PERCENT (g) |                              42.5%                                             97.0%                        | 
|TERMINAL (d)       |                              3/10 (30%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              240                                               260                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P<0.001 **                   | 
|POLY 1.5           |                                                                                P<0.001 **                   | 
|POLY 6             |                                                                                P<0.001 **                   | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P<0.001 **                   | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/50 (24%)                                       6/66 (9%)                    | 
|POLY-3 RATE (b)    |                              12/23.70                                          6/14.33                      | 
|POLY-3 PERCENT (g) |                              50.6%                                             41.9%                        | 
|TERMINAL (d)       |                              5/10 (50%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              504                                               222                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.032 *                    | 
|POLY 3             |                                                                                P=0.491N                     | 
|POLY 1.5           |                                                                                P=0.124N                     | 
|POLY 6             |                                                                                P=0.607                      | 
|LOGISTIC REGRESSION|                                                                                P=0.611N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.027N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 4       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/50 (24%)                                       6/66 (9%)                    | 
|POLY-3 RATE (b)    |                              12/23.70                                          6/14.33                      | 
|POLY-3 PERCENT (g) |                              50.6%                                             41.9%                        | 
|TERMINAL (d)       |                              5/10 (50%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              504                                               222                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.032 *                    | 
|POLY 3             |                                                                                P=0.491N                     | 
|POLY 1.5           |                                                                                P=0.124N                     | 
|POLY 6             |                                                                                P=0.607                      | 
|LOGISTIC REGRESSION|                                                                                P=0.611N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.027N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              13/50 (26%)                                       6/66 (9%)                    | 
|POLY-3 RATE (b)    |                              13/24.67                                          6/14.33                      | 
|POLY-3 PERCENT (g) |                              52.7%                                             41.9%                        | 
|TERMINAL (d)       |                              5/10 (50%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              209                                               222                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.089                      | 
|POLY 3             |                                                                                P=0.445N                     | 
|POLY 1.5           |                                                                                P=0.091N                     | 
|POLY 6             |                                                                                P=0.652                      | 
|LOGISTIC REGRESSION|                                                                                P=0.364N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.015N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 5       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/49 (8%)                                         1/66 (2%)                    | 
|POLY-3 RATE (b)    |                              4/20.74                                           1/9.62                       | 
|POLY-3 PERCENT (g) |                              19.3%                                             10.4%                        | 
|TERMINAL (d)       |                              3/9 (33%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              474                                               636                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.383                      | 
|POLY 3             |                                                                                P=0.640N                     | 
|POLY 1.5           |                                                                                P=0.264N                     | 
|POLY 6             |                                                                                P=0.978                      | 
|LOGISTIC REGRESSION|                                                                                P=0.658                      | 
|COCH-ARM / FISHERS |                                                                                P=0.104N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/49 (8%)                                         1/66 (2%)                    | 
|POLY-3 RATE (b)    |                              4/20.74                                           1/9.62                       | 
|POLY-3 PERCENT (g) |                              19.3%                                             10.4%                        | 
|TERMINAL (d)       |                              3/9 (33%)                                         0/0 (0%)                     | 
|FIRST INCIDENCE    |                              474                                               636                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.383                      | 
|POLY 3             |                                                                                P=0.640N                     | 
|POLY 1.5           |                                                                                P=0.264N                     | 
|POLY 6             |                                                                                P=0.978                      | 
|LOGISTIC REGRESSION|                                                                                P=0.658                      | 
|COCH-ARM / FISHERS |                                                                                P=0.104N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 6       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              8/50 (16%)                                        3/66 (5%)                    | 
|POLY-3 RATE (b)    |                              8/23.57                                           3/11.72                      | 
|POLY-3 PERCENT (g) |                              33.9%                                             25.6%                        | 
|TERMINAL (d)       |                              2/10 (20%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              541                                               300                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.199                      | 
|POLY 3             |                                                                                P=0.571N                     | 
|POLY 1.5           |                                                                                P=0.172N                     | 
|POLY 6             |                                                                                P=0.775                      | 
|LOGISTIC REGRESSION|                                                                                P=0.459N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.039N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              28/50 (56%)                                       45/66 (68%)                  | 
|POLY-3 RATE (b)    |                              28/33.21                                          45/45.91                     | 
|POLY-3 PERCENT (g) |                              84.3%                                             98.0%                        | 
|TERMINAL (d)       |                              9/10 (90%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              240                                               222                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P=0.006 **                   | 
|POLY 1.5           |                                                                                P=0.011 *                    | 
|POLY 6             |                                                                                P=0.013 *                    | 
|LOGISTIC REGRESSION|                                                                                P<0.001 **                   | 
|COCH-ARM / FISHERS |                                                                                P=0.125                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/10/04                           EXPERIMENT: 96022 TEST: 02                                            Page 7       
                     Statistical Analysis of Primary Tumors in Rats(SD)       -       TEF EVALUATION (PCB MIXTURE;PCB 126/P         
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              20/50 (40%)                                       14/66 (21%)                  | 
|POLY-3 RATE (b)    |                              20/26.17                                          14/18.90                     | 
|POLY-3 PERCENT (g) |                              76.4%                                             74.1%                        | 
|TERMINAL (d)       |                              8/10 (80%)                                        0/0 (0%)                     | 
|FIRST INCIDENCE    |                              209                                               294                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P=0.635N                     | 
|POLY 1.5           |                                                                                P=0.141N                     | 
|POLY 6             |                                                                                P=0.442                      | 
|LOGISTIC REGRESSION|                                                                                P=0.158                      | 
|COCH-ARM / FISHERS |                                                                                P=0.023N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              4000 NG/                                          4000 NG/                     | 
|                   |                              500UG ST                                          500 UG                       | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              36/50 (72%)                                       45/66 (68%)                  | 
|POLY-3 RATE (b)    |                              36/36.81                                          45/45.91                     | 
|POLY-3 PERCENT (g) |                              97.8%                                             98.0%                        | 
|TERMINAL (d)       |                              10/10 (100%)                                      0/0 (0%)                     | 
|FIRST INCIDENCE    |                              209                                               222                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P<0.001 **                   | 
|POLY 3             |                                                                                P=0.961                      | 
|POLY 1.5           |                                                                                P=0.690N                     | 
|POLY 6             |                                                                                P=1.000                      | 
|LOGISTIC REGRESSION|                                                                                P=0.353                      | 
|COCH-ARM / FISHERS |                                                                                P=0.407N                     | 
|ORDER RESTRICTED   |                                                                                (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).