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TDMS Study 96020-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                      TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153)                   DATE: 03/03/04       
EXPERIMENT: 96020 TEST: 01                                                                                     TIME: 13:56:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96020       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFBINARYMIX    
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                                                       53 WEEK SSAC FINAL #1                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     091699 091799                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG /  0 UG                                                                  
                                       INCLUDE 004    300 NG /100 UG                                                                
                                       INCLUDE 005    300 NG /300 UG                                                                
                                       INCLUDE 006    300 NG /3000 UG                                                               
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                      TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153)                   DATE: 03/03/04       
EXPERIMENT: 96020 TEST: 01                                                                                     TIME: 13:56:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96020       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFBINARYMIX    
Rats(SPRAGUE-DAWLEY)                                                                                                                
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                      TEF EVALUATION (BINARY MIXTURE; PCB 126/PCB 153)                   DATE: 03/03/04       
EXPERIMENT: 96020 TEST: 01                                                                                     TIME: 13:56:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96020       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFBINARYMIX    
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF    TEF EVALUATION (BINARY MIXTURE; PCB 126                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Mammary Gland                          Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma or Adenoma                                                                         
===============================================================                                                                     
                                                                                                                                   
       Date:  03/03/04                           EXPERIMENT: 96020 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -     TEF EVALUATION (BINARY MIXTURE; PCB 126                 
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/13 (0%)                2/10 (20%)               3/13 (23%)               1/9 (11%)       | 
|POLY-3 RATE (b)    |                  0/0.64                   2/2.39                   3/3.49                   1/1.39          | 
|POLY-3 PERCENT (g) |                  0.0%                     83.6%                    85.9%                    71.8%           | 
|INT SACRIFICE 1 (c)|                  0/13 (0%)                2/10 (20%)               3/13 (23.1%)             1/9 (11.1%)     | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      366 (I)                  366 (I)                  366 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.674N                 P=0.179                  P=0.114                  P=0.427         | 
|POLY 3             |                  P=0.511N                 P=0.047 *                P=0.031 *                P=0.125         | 
|POLY 1.5           |                  P=0.542N                 P=0.065                  P=0.042 *                P=0.172         | 
|POLY 6             |                  P=0.501N                 P=0.043 *                P=0.029 *                P=0.113         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.676N                 P=0.178                  P=0.110                  P=0.409         | 
|ORDER RESTRICTED   |                  P=0.101                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/13 (0%)                2/10 (20%)               3/13 (23%)               1/9 (11%)       | 
|POLY-3 RATE (b)    |                  0/0.64                   2/2.39                   3/3.49                   1/1.39          | 
|POLY-3 PERCENT (g) |                  0.0%                     83.6%                    85.9%                    71.8%           | 
|INT SACRIFICE 1 (c)|                  0/13 (0%)                2/10 (20%)               3/13 (23.1%)             1/9 (11.1%)     | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      366 (I)                  366 (I)                  366 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.674N                 P=0.179                  P=0.114                  P=0.427         | 
|POLY 3             |                  P=0.511N                 P=0.047 *                P=0.031 *                P=0.125         | 
|POLY 1.5           |                  P=0.542N                 P=0.065                  P=0.042 *                P=0.172         | 
|POLY 6             |                  P=0.501N                 P=0.043 *                P=0.029 *                P=0.113         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.676N                 P=0.178                  P=0.110                  P=0.409         | 
|ORDER RESTRICTED   |                  P=0.101                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/03/04                           EXPERIMENT: 96020 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -     TEF EVALUATION (BINARY MIXTURE; PCB 126                  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  0/13 (0%)                2/10 (20%)               4/13 (31%)               1/9 (11%)       | 
|POLY-3 RATE (b)    |                  0/0.64                   2/2.39                   4/4.44                   1/1.39          | 
|POLY-3 PERCENT (g) |                  0.0%                     83.6%                    90.0%                    71.8%           | 
|INT SACRIFICE 1 (c)|                  0/13 (0%)                2/10 (20%)               4/13 (30.8%)             1/9 (11.1%)     | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  ---                      366 (I)                  366 (I)                  366 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.610N                 P=0.179                  P=0.055                  P=0.427         | 
|POLY 3             |                  P=0.452N                 P=0.047 *                P=0.011 *                P=0.125         | 
|POLY 1.5           |                  P=0.483N                 P=0.065                  P=0.016 *                P=0.172         | 
|POLY 6             |                  P=0.443N                 P=0.043 *                P=0.011 *                P=0.113         | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.611N                 P=0.178                  P=0.048 *                P=0.409         | 
|ORDER RESTRICTED   |                  P=0.070                  (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/8 (25%)                0/10 (0%)                1/8 (13%)                0/9 (0%)        | 
|POLY-3 RATE (b)    |                  2/2.30                   0/0.49                   1/1.34                   0/0.44          | 
|POLY-3 PERCENT (g) |                  87.1%                    0.0%                     74.4%                    0.0%            | 
|INT SACRIFICE 1 (c)|                  2/8 (25%)                0/10 (0%)                1/8 (12.5%)              0/9 (0%)        | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  366 (I)                  ---                      366 (I)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.326N                 P=0.185N                 P=0.500N                 P=0.207N        | 
|POLY 3             |                  P=0.137N                 P=0.047N*                P=0.314N                 P=0.057N        | 
|POLY 1.5           |                  P=0.166N                 P=0.066N                 P=0.348N                 P=0.078N        | 
|POLY 6             |                  P=0.133N                 P=0.043N*                P=0.304N                 P=0.052N        | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.323N                 P=0.183N                 P=0.500N                 P=0.206N        | 
|ORDER RESTRICTED   |                  P=0.170N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/03/04                           EXPERIMENT: 96020 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -     TEF EVALUATION (BINARY MIXTURE; PCB 126                  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/8 (25%)                0/10 (0%)                1/8 (13%)                0/9 (0%)        | 
|POLY-3 RATE (b)    |                  2/2.30                   0/0.49                   1/1.34                   0/0.44          | 
|POLY-3 PERCENT (g) |                  87.1%                    0.0%                     74.4%                    0.0%            | 
|INT SACRIFICE 1 (c)|                  2/8 (25%)                0/10 (0%)                1/8 (12.5%)              0/9 (0%)        | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  366 (I)                  ---                      366 (I)                  ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.326N                 P=0.185N                 P=0.500N                 P=0.207N        | 
|POLY 3             |                  P=0.137N                 P=0.047N*                P=0.314N                 P=0.057N        | 
|POLY 1.5           |                  P=0.166N                 P=0.066N                 P=0.348N                 P=0.078N        | 
|POLY 6             |                  P=0.133N                 P=0.043N*                P=0.304N                 P=0.052N        | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.323N                 P=0.183N                 P=0.500N                 P=0.206N        | 
|ORDER RESTRICTED   |                  P=0.170N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/13 (15%)               2/10 (20%)               3/13 (23%)               1/9 (11%)       | 
|POLY-3 RATE (b)    |                  2/2.54                   2/2.39                   3/3.49                   1/1.39          | 
|POLY-3 PERCENT (g) |                  78.7%                    83.6%                    85.9%                    71.8%           | 
|INT SACRIFICE 1 (c)|                  2/13 (15.4%)             2/10 (20%)               3/13 (23.1%)             1/9 (11.1%)     | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  366 (I)                  366 (I)                  366 (I)                  366 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.470N                 P=0.602                  P=0.500                  P=0.632N        | 
|POLY 3             |                  P=0.330N                 P=0.436                  P=0.354                  P=0.431N        | 
|POLY 1.5           |                  P=0.355N                 P=0.466                  P=0.381                  P=0.468N        | 
|POLY 6             |                  P=0.323N                 P=0.428                  P=0.347                  P=0.422N        | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.470N                 P=0.596                  P=0.500                  P=0.642N        | 
|ORDER RESTRICTED   |                  P=0.506N                 (e)                      (e)                      (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  03/03/04                           EXPERIMENT: 96020 TEST: 01                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -     TEF EVALUATION (BINARY MIXTURE; PCB 126                  
                                         Terminal Sacrifice at 143 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                  0 NG /                   300 NG /                 300 NG /                 300 NG /        | 
|                   |                  0 UG                     100 UG                   300 UG                   3000 UG         | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                  #                        #                        #                        #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                  2/13 (15%)               2/10 (20%)               4/13 (31%)               1/9 (11%)       | 
|POLY-3 RATE (b)    |                  2/2.54                   2/2.39                   4/4.44                   1/1.39          | 
|POLY-3 PERCENT (g) |                  78.7%                    83.6%                    90.0%                    71.8%           | 
|INT SACRIFICE 1 (c)|                  2/13 (15.4%)             2/10 (20%)               4/13 (30.8%)             1/9 (11.1%)     | 
|TERMINAL (d)       |                  0/0 (0%)                 0/0 (0%)                 0/0 (0%)                 0/0 (0%)        | 
|FIRST INCIDENCE    |                  366 (I)                  366 (I)                  366 (I)                  366 (I)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                  P=0.420N                 P=0.602                  P=0.324                  P=0.632N        | 
|POLY 3             |                  P=0.290N                 P=0.436                  P=0.211                  P=0.431N        | 
|POLY 1.5           |                  P=0.314N                 P=0.466                  P=0.231                  P=0.468N        | 
|POLY 6             |                  P=0.284N                 P=0.428                  P=0.205                  P=0.422N        | 
|LOGISTIC REGRESSION|                  (e)                      (e)                      (e)                      (e)             | 
|COCH-ARM / FISHERS |                  P=0.419N                 P=0.596                  P=0.322                  P=0.642N        | 
|ORDER RESTRICTED   |                  P=0.442N                 (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).