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TDMS Study 05077-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                           FIREMASTER FF-1 POLYBROMINATED BIPHENYL                       DATE: 09/10/94       
EXPERIMENT: 05077 TEST: 02                                                                                     TIME: 09:42:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 53634B       
PATHOLOGIST: M. RYAN                         S. EUSTIS                                                         CAS: 67774327        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                           FIREMASTER FF-1 POLYBROMINATED BIPHENYL                       DATE: 09/10/94      
EXPERIMENT: 05077 TEST: 02                                                                                     TIME: 09:42:39      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 53634B      
PATHOLOGIST: M. RYAN                         S. EUSTIS                                                         CAS: 67774327       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             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 NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                           FIREMASTER FF-1 POLYBROMINATED BIPHENYL                       DATE: 09/10/94       
EXPERIMENT: 05077 TEST: 02                                                                                     TIME: 09:42:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 53634B       
PATHOLOGIST: M. RYAN                         S. EUSTIS                                                         CAS: 67774327        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                             IN THE ANALYSIS OF THE STUDY OF FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                             Harderian Gland               Adenoma
                             Liver                         Hemangiosarcoma
                                                           Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Spleen                        Hemangiosarcoma
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                           FIREMASTER FF-1 POLYBROMINATED BIPHENYL                       DATE: 09/10/94       
EXPERIMENT: 05077 TEST: 02                                                                                     TIME: 09:42:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-82151          ROUTE: DOSED FEED                                                                  NTP C#: 53634B       
PATHOLOGIST: M. RYAN                         S. EUSTIS                                                         CAS: 67774327        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                             IN THE ANALYSIS OF THE STUDY OF FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Bone Marrow                   Hemangiosarcoma
                             Harderian Gland               Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Histiocytic Sarcoma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   1
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/88 (5%)    2/47 (4%)    4/148 (3%)   0/95 (0%)  |  1/99 (1%)    0/50 (0%)    0/148 (0%)   1/90 (1%)  |
|ADJUSTED (b)           |   6.7%         4.9%         4.0%         0.0%      |   1.2%         0.0%         0.0%         1.2%      |
|TERMINAL (d)           |  2/53 (4%)    2/41 (5%)    3/97 (3%)    0/0        |  1/84 (1%)    0/32 (0%)    0/87 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   714          727 (T)      708          ---       |   729 (T)      ---          ---          470       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.483N     P=0.490N     P=0.335N       (e)      |  P=0.352      P=0.692N     P=0.493N     P=0.460    |
|INCIDENTAL TUMOR       |  P=0.164N     P=0.663      P=0.353N     P=0.225N   |  P=0.802      P=0.692N     P=0.493N     P=0.906    |
|LOGISTIC REGRESSION    |  P=0.307N     P=0.521N     P=0.311N     P=0.760N   |  P=0.748      P=0.692N     P=0.493N     P=0.822N   |
|COCHRAN-ARMITAGE       |  P=0.038N*                                         |  P=0.560                                           |
|FISHER EXACT           |               P=0.653N     P=0.342N     P=0.052N   |               P=0.664N     P=0.401N     P=0.727    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/49 (0%)    3/148 (2%)   0/100 (0%) |  0/100 (0%)   3/50 (6%)    4/150 (3%)   0/98 (0%)  |
|ADJUSTED (b)           |   2.7%         0.0%         2.7%         0.0%      |   0.0%         8.4%         3.6%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    0/97 (0%)    0/0        |  0/84 (0%)    2/32 (6%)    1/88 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |   658          ---          604          ---       |   ---          621          640          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.711N     P=0.362N     P=0.660N     P=0.813N   |  P=0.487      P=0.020 *    P=0.103        (e)      |
|INCIDENTAL TUMOR       |  P=0.117N     P=0.778N     P=0.671N     P=0.237N   |  P=0.284N     P=0.049 *    P=0.301        (e)      |
|LOGISTIC REGRESSION    |  P=0.303N     P=0.407N     P=0.672      P=0.426N   |  P=0.354N     P=0.032 *    P=0.138        (e)      |
|COCHRAN-ARMITAGE       |  P=0.235N                                          |  P=0.231N                                          |
|FISHER EXACT           |               P=0.449N     P=0.678      P=0.249N   |               P=0.036 *    P=0.128        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   2
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/100 (5%)   5/49 (10%)   4/150 (3%)   1/100 (1%) |  4/100 (4%)   4/50 (8%)    4/150 (3%)   0/98 (0%)  |
|ADJUSTED (b)           |   7.4%        11.5%         3.9%         3.1%      |   4.7%        11.2%         4.5%         0.0%      |
|TERMINAL (d)           |  3/63 (5%)    4/42 (10%)   3/97 (3%)    0/0        |  3/84 (4%)    2/32 (6%)    4/88 (5%)    0/0        |
|FIRST INCIDENCE (DAYS) |   665          605          684          625       |   723          624          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.602N     P=0.341      P=0.251N     P=0.428    |  P=0.566N     P=0.162      P=0.614N       (e)      |
|INCIDENTAL TUMOR       |  P=0.105N     P=0.176      P=0.267N     P=0.341N   |  P=0.172N     P=0.402      P=0.510N     P=0.464N   |
|LOGISTIC REGRESSION    |  P=0.153N     P=0.221      P=0.258N     P=0.561N   |  P=0.280N     P=0.230      P=0.586N     P=1.000N   |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |  P=0.024N*                                         |
|FISHER EXACT           |               P=0.197      P=0.263N     P=0.106N   |               P=0.254      P=0.405N     P=0.063N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/99 (2%)    0/49 (0%)    1/150 (1%)   0/96 (0%)  |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/90 (0%)  |
|ADJUSTED (b)           |   2.8%         0.0%         1.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/62 (2%)    0/42 (0%)    1/97 (1%)    0/0        |  0/84 (0%)    0/32 (0%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   655          ---          727 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.590N     P=0.353N     P=0.351N     P=0.826N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.395N     P=0.501N     P=0.358N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.350N     P=0.401N     P=0.356N     P=0.490N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.228N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.446N     P=0.348N     P=0.256N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   3
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   1/49 (2%)    0/150 (0%)   0/100 (0%) |  1/100 (1%)   0/50 (0%)    2/150 (1%)   0/98 (0%)  |
|ADJUSTED (b)           |   1.6%         2.4%         0.0%         0.0%      |   1.2%         0.0%         2.3%         0.0%      |
|TERMINAL (d)           |  1/63 (2%)    1/42 (2%)    0/97 (0%)    0/0        |  1/84 (1%)    0/32 (0%)    2/88 (2%)    0/0        |
|FIRST INCIDENCE (DAYS) |   727 (T)      727 (T)      ---          ---       |   729 (T)      ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.632N     P=0.668      P=0.414N       (e)      |  P=0.706      P=0.692N     P=0.516        (e)      |
|INCIDENTAL TUMOR       |  P=0.632N     P=0.668      P=0.414N       (e)      |  P=0.706      P=0.692N     P=0.516        (e)      |
|LOGISTIC REGRESSION    |  P=0.632N     P=0.668      P=0.414N       (e)      |  P=0.706      P=0.692N     P=0.516        (e)      |
|COCHRAN-ARMITAGE       |  P=0.260N                                          |  P=0.407N                                          |
|FISHER EXACT           |               P=0.551      P=0.400N     P=0.500N   |               P=0.667N     P=0.649      P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/100 (8%)   3/48 (6%)   10/148 (7%)   0/100 (0%) |  0/100 (0%)   1/50 (2%)    5/150 (3%)   0/95 (0%)  |
|ADJUSTED (b)           |  11.8%         6.9%         8.9%         0.0%      |   0.0%         3.1%         4.6%         0.0%      |
|TERMINAL (d)           |  5/63 (8%)    2/42 (5%)    4/97 (4%)    0/0        |  0/84 (0%)    1/32 (3%)    2/88 (2%)    0/0        |
|FIRST INCIDENCE (DAYS) |   658          605          561          ---       |   ---          729 (T)      624          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.335N     P=0.311N     P=0.416N     P=0.836N   |  P=0.209      P=0.308      P=0.059        (e)      |
|INCIDENTAL TUMOR       |  P=0.006N**   P=0.554N     P=0.396N     P=0.118N   |  P=0.709N     P=0.308      P=0.166        (e)      |
|LOGISTIC REGRESSION    |  P=0.021N*    P=0.442N     P=0.450N     P=0.253N   |  P=0.717N     P=0.308      P=0.088        (e)      |
|COCHRAN-ARMITAGE       |  P=0.006N**                                        |  P=0.422N                                          |
|FISHER EXACT           |               P=0.496N     P=0.447N     P=0.003N** |               P=0.333      P=0.076        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   4
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/100 (40%) 30/48 (63%) 142/148 (96%) 90/100 (90%)| 23/100 (23%)  6/50 (12%) 124/150 (83%) 87/95 (92%) |
|ADJUSTED (b)           |  53.9%        66.6%        99.3%       100.0%      |  26.4%        17.5%        93.1%       100.0%      |
|TERMINAL (d)           | 30/63 (48%)  27/42 (64%)  96/97 (99%)   0/0        | 20/84 (24%)   5/32 (16%)  79/88 (90%)   0/0        |
|FIRST INCIDENCE (DAYS) |   531          307          391          314       |   620          621          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.250      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.231N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.040 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.098N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.016 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.128N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.008 **   P<0.001 **   P<0.001 ** |               P=0.080N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/100 (25%)  8/48 (17%) 101/148 (68%) 71/100 (71%)|  5/100 (5%)   2/50 (4%)   92/150 (61%) 64/95 (67%) |
|ADJUSTED (b)           |  32.6%        19.0%        80.5%       100.0%      |   5.9%         5.3%        70.8%        97.1%      |
|TERMINAL (d)           | 14/63 (22%)   8/42 (19%)  73/97 (75%)   0/0        |  4/84 (5%)    1/32 (3%)   51/88 (58%)   0/0        |
|FIRST INCIDENCE (DAYS) |   447          727 (T)      391          314       |   708          621          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.051N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.662      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.263N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.467N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.162N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.581N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.177N     P<0.001 **   P<0.001 ** |               P=0.571N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   5
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 56/100 (56%) 31/48 (65%) 142/148 (96%) 98/100 (98%)| 26/100 (26%)  8/50 (16%) 136/150 (91%) 94/95 (99%) |
|ADJUSTED (b)           |  68.5%        68.8%        99.3%       100.0%      |  29.8%        22.4%        97.1%       100.0%      |
|TERMINAL (d)           | 38/63 (60%)  28/42 (67%)  96/97 (99%)   0/0        | 23/84 (27%)   6/32 (19%)  84/88 (95%)   0/0        |
|FIRST INCIDENCE (DAYS) |   447          307          391          314       |   620          621          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.232N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.327N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.307      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.133N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.261      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.179N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.208      P<0.001 **   P<0.001 ** |               P=0.119N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 56/100 (56%) 31/48 (65%) 142/148 (96%) 98/100 (98%)| 26/100 (26%)  8/50 (16%) 136/150 (91%) 94/95 (99%) |
|ADJUSTED (b)           |  68.5%        68.8%        99.3%       100.0%      |  29.8%        22.4%        97.1%       100.0%      |
|TERMINAL (d)           | 38/63 (60%)  28/42 (67%)  96/97 (99%)   0/0        | 23/84 (27%)   6/32 (19%)  84/88 (95%)   0/0        |
|FIRST INCIDENCE (DAYS) |   447          307          391          314       |   620          621          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.232N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.327N     P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.307      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.133N     P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.261      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.179N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.208      P<0.001 **   P<0.001 ** |               P=0.119N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   6
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   0/48 (0%)    2/148 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/95 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         1.7%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/63 (2%)    0/42 (0%)    1/97 (1%)    0/0        |  0/84 (0%)    0/32 (0%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   678          ---          421          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546N     P=0.350N     P=0.535N     P=0.898N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.173N     P=0.503N     P=0.638N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.182N     P=0.400N     P=0.537N     P=0.597N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.230N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.455N     P=0.531N     P=0.249N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/100 (21%) 11/49 (22%)  32/150 (21%)  4/96 (4%)  |  2/100 (2%)   2/50 (4%)    6/150 (4%)   2/90 (2%)  |
|ADJUSTED (b)           |  29.9%        25.0%        30.7%         6.3%      |   2.3%         5.9%         6.2%        15.4%      |
|TERMINAL (d)           | 16/63 (25%)   9/42 (21%)  27/97 (28%)   0/0        |  1/84 (1%)    1/32 (3%)    4/88 (5%)    0/0        |
|FIRST INCIDENCE (DAYS) |   531          662          475          440       |   708          692          651          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.118      P=0.344N     P=0.547N     P=0.287    |  P=0.006 **   P=0.336      P=0.181      P=0.040 *  |
|INCIDENTAL TUMOR       |  P=0.085N     P=0.553      P=0.498      P=0.036N*  |  P=0.441      P=0.594      P=0.407      P=0.620N   |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.563      P=0.551      P=0.011N*  |  P=0.361      P=0.614      P=0.278      P=0.594    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.523N                                          |
|FISHER EXACT           |               P=0.498      P=0.540      P<0.001N** |               P=0.407      P=0.312      P=0.649    |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   7
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/100 (7%)   1/49 (2%)    1/150 (1%)   2/96 (2%)  |  2/100 (2%)   3/50 (6%)    2/150 (1%)   0/90 (0%)  |
|ADJUSTED (b)           |  10.4%         2.4%         1.0%        35.7%      |   2.2%         8.4%         2.1%         0.0%      |
|TERMINAL (d)           |  4/63 (6%)    1/42 (2%)    0/97 (0%)    0/0        |  1/84 (1%)    2/32 (6%)    1/88 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |   698          727 (T)      723          635       |   451          621          697          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.513      P=0.113N     P=0.007N**   P=0.021 *  |  P=0.436N     P=0.159      P=0.631N     P=0.535N   |
|INCIDENTAL TUMOR       |  P=0.182N     P=0.252N     P=0.008N**   P=0.378N   |  P=0.051N     P=0.207      P=0.576N     P=0.116N   |
|LOGISTIC REGRESSION    |  P=0.467N     P=0.147N     P=0.007N**   P=0.539    |  P=0.058N     P=0.268      P=0.508N     P=0.089N   |
|COCHRAN-ARMITAGE       |  P=0.121N                                          |  P=0.089N                                          |
|FISHER EXACT           |               P=0.195N     P=0.008N**   P=0.095N   |               P=0.207      P=0.525N     P=0.276N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/100 (28%) 12/49 (24%)  33/150 (22%)  6/96 (6%)  |  4/100 (4%)   5/50 (10%)   8/150 (5%)   2/90 (2%)  |
|ADJUSTED (b)           |  38.6%        27.3%        31.4%        39.8%      |   4.5%        14.0%         8.2%        15.4%      |
|TERMINAL (d)           | 20/63 (32%)  10/42 (24%)  27/97 (28%)   0/0        |  2/84 (2%)    3/32 (9%)    5/88 (6%)    0/0        |
|FIRST INCIDENCE (DAYS) |   531          662          475          440       |   451          621          651          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.094      P=0.125N     P=0.149N     P=0.049 *  |  P=0.075      P=0.080      P=0.257      P=0.241    |
|INCIDENTAL TUMOR       |  P=0.031N*    P=0.405N     P=0.200N     P=0.027N*  |  P=0.271N     P=0.208      P=0.509      P=0.186N   |
|LOGISTIC REGRESSION    |  P=0.023N*    P=0.319N     P=0.162N     P=0.021N*  |  P=0.329N     P=0.159      P=0.439      P=0.350N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.160N                                          |
|FISHER EXACT           |               P=0.402N     P=0.176N     P<0.001N** |               P=0.138      P=0.436      P=0.392N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   8
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/49 (0%)    0/150 (0%)   0/100 (0%) |  0/100 (0%)   2/50 (4%)    1/150 (1%)   0/98 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         5.5%         1.1%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    0/97 (0%)    0/0        |  0/84 (0%)    1/32 (3%)    1/88 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          640          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.860      P=0.078      P=0.509        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.452N     P=0.185      P=0.509        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.585N     P=0.109      P=0.509        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.329N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.110      P=0.600        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/96 (2%)    0/48 (0%)    1/146 (1%)   0/91 (0%)  |
|ADJUSTED (b)           |                                                    |   2.4%         0.0%         1.2%         0.0%      |
|TERMINAL (d)           |                                                    |  2/83 (2%)    0/32 (0%)    1/86 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.763N     P=0.464N     P=0.488N       (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.763N     P=0.464N     P=0.488N       (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.763N     P=0.464N     P=0.488N       (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.232N                                          |
|FISHER EXACT           |                                                    |               P=0.443N     P=0.347N     P=0.262N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE   9
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/96 (1%)    1/48 (2%)    2/146 (1%)   0/91 (0%)  |
|ADJUSTED (b)           |                                                    |   1.2%         3.1%         1.9%         0.0%      |
|TERMINAL (d)           |                                                    |  1/83 (1%)    1/32 (3%)    1/86 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      563          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.785      P=0.536      P=0.558        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.503N     P=0.536      P=0.679        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.428N     P=0.536      P=0.669        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.287N                                          |
|FISHER EXACT           |                                                    |               P=0.557      P=0.653      P=0.513N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/88 (0%)    0/45 (0%)    1/131 (1%)   0/75 (0%)  | 11/95 (12%)  10/49 (20%)  24/139 (17%)  0/74 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.1%         0.0%      |  13.4%        30.0%        25.2%         0.0%      |
|TERMINAL (d)           |  0/55 (0%)    0/40 (0%)    1/87 (1%)    0/0        | 11/82 (13%)   9/32 (28%)  16/83 (19%)   0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          727 (T)      ---       |   729 (T)      677          653          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.887        (e)        P=0.591        (e)      |  P=0.069      P=0.029 *    P=0.023 *      (e)      |
|INCIDENTAL TUMOR       |  P=0.887        (e)        P=0.591        (e)      |  P=0.508      P=0.039 *    P=0.122        (e)      |
|LOGISTIC REGRESSION    |  P=0.887        (e)        P=0.591        (e)      |  P=0.566      P=0.043 *    P=0.070        (e)      |
|COCHRAN-ARMITAGE       |  P=0.797N                                          |  P=0.002N**                                        |
|FISHER EXACT           |                 (e)        P=0.598        (e)      |               P=0.121      P=0.156      P=0.001N** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  10
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/49 (0%)    3/150 (2%)   0/100 (0%) |  1/100 (1%)   2/50 (4%)    0/150 (0%)   0/98 (0%)  |
|ADJUSTED (b)           |   1.2%         0.0%         3.0%         0.0%      |   1.1%         6.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    2/97 (2%)    0/0        |  0/84 (0%)    2/32 (6%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   652          ---          709          ---       |   612          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.623      P=0.622N     P=0.472      P=0.817N   |  P=0.481N     P=0.214      P=0.417N     P=0.837N   |
|INCIDENTAL TUMOR       |  P=0.588N     P=0.916N     P=0.454      P=0.500N   |  P=0.196N     P=0.347      P=0.205N     P=0.134N   |
|LOGISTIC REGRESSION    |  P=0.674N     P=0.643N     P=0.461      P=0.602N   |  P=0.203N     P=0.275      P=0.385N     P=0.492N   |
|COCHRAN-ARMITAGE       |  P=0.385N                                          |  P=0.170N                                          |
|FISHER EXACT           |               P=0.671N     P=0.475      P=0.500N   |               P=0.258      P=0.400N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/49 (0%)    2/150 (1%)   0/100 (0%) |  0/100 (0%)   1/50 (2%)    3/150 (2%)   0/98 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.7%         0.0%      |   0.0%         2.3%         3.1%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    0/97 (0%)    0/0        |  0/84 (0%)    0/32 (0%)    2/88 (2%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          631          ---       |   ---          621          654          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.643        (e)        P=0.342        (e)      |  P=0.463      P=0.360      P=0.148        (e)      |
|INCIDENTAL TUMOR       |  P=0.439N       (e)        P=0.374        (e)      |  P=0.626N     P=0.612      P=0.222        (e)      |
|LOGISTIC REGRESSION    |  P=0.760N       (e)        P=0.332        (e)      |  P=0.663N     P=0.417      P=0.198        (e)      |
|COCHRAN-ARMITAGE       |  P=0.662N                                          |  P=0.445N                                          |
|FISHER EXACT           |                 (e)        P=0.359        (e)      |               P=0.333      P=0.214        (e)      |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  11
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/49 (0%)    5/150 (3%)   0/100 (0%) |  1/100 (1%)   2/50 (4%)    0/150 (0%)   0/98 (0%)  |
|ADJUSTED (b)           |   1.2%         0.0%         4.6%         0.0%      |   1.1%         6.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    2/97 (2%)    0/0        |  0/84 (0%)    2/32 (6%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   652          ---          607          ---       |   612          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442      P=0.622N     P=0.236      P=0.817N   |  P=0.481N     P=0.214      P=0.417N     P=0.837N   |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.916N     P=0.240      P=0.500N   |  P=0.196N     P=0.347      P=0.205N     P=0.134N   |
|LOGISTIC REGRESSION    |  P=0.550N     P=0.643N     P=0.224      P=0.602N   |  P=0.203N     P=0.275      P=0.385N     P=0.492N   |
|COCHRAN-ARMITAGE       |  P=0.360N                                          |  P=0.170N                                          |
|FISHER EXACT           |               P=0.671N     P=0.230      P=0.500N   |               P=0.258      P=0.400N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/49 (0%)    5/150 (3%)   0/100 (0%) |  1/100 (1%)   2/50 (4%)    0/150 (0%)   0/98 (0%)  |
|ADJUSTED (b)           |   1.2%         0.0%         4.6%         0.0%      |   1.1%         6.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    2/97 (2%)    0/0        |  0/84 (0%)    2/32 (6%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   652          ---          607          ---       |   612          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442      P=0.622N     P=0.236      P=0.817N   |  P=0.481N     P=0.214      P=0.417N     P=0.837N   |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.916N     P=0.240      P=0.500N   |  P=0.196N     P=0.347      P=0.205N     P=0.134N   |
|LOGISTIC REGRESSION    |  P=0.550N     P=0.643N     P=0.224      P=0.602N   |  P=0.203N     P=0.275      P=0.385N     P=0.492N   |
|COCHRAN-ARMITAGE       |  P=0.360N                                          |  P=0.170N                                          |
|FISHER EXACT           |               P=0.671N     P=0.230      P=0.500N   |               P=0.258      P=0.400N     P=0.505N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  12
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/49 (0%)    2/150 (1%)   0/100 (0%) |  0/100 (0%)   0/50 (0%)    0/150 (0%)   0/98 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.7%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    0/97 (0%)    0/0        |  0/84 (0%)    0/32 (0%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          607          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.662        (e)        P=0.337        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.439N       (e)        P=0.374        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.695N       (e)        P=0.335        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.662N                                          |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.359        (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/100 (5%)   5/47 (11%)   5/147 (3%)   2/97 (2%)  |  2/98 (2%)    2/50 (4%)    7/150 (5%)   0/91 (0%)  |
|ADJUSTED (b)           |   7.1%        11.8%         4.6%         5.8%      |   2.4%         6.3%         6.7%         0.0%      |
|TERMINAL (d)           |  1/63 (2%)    4/41 (10%)   1/97 (1%)    0/0        |  2/84 (2%)    2/32 (6%)    3/88 (3%)    0/0        |
|FIRST INCIDENCE (DAYS) |   658          605          604          587       |   729 (T)      729 (T)      640          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.380      P=0.332      P=0.351N     P=0.153    |  P=0.266      P=0.327      P=0.129        (e)      |
|INCIDENTAL TUMOR       |  P=0.045N*    P=0.065      P=0.383N     P=0.147N   |  P=0.564N     P=0.327      P=0.367        (e)      |
|LOGISTIC REGRESSION    |  P=0.082N     P=0.197      P=0.381N     P=0.623N   |  P=0.649N     P=0.327      P=0.225        (e)      |
|COCHRAN-ARMITAGE       |  P=0.089N                                          |  P=0.149N                                          |
|FISHER EXACT           |               P=0.178      P=0.377N     P=0.235N   |               P=0.415      P=0.236      P=0.268N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  13
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/100 (1%)   0/49 (0%)    0/150 (0%)   1/100 (1%) |  3/100 (3%)   2/50 (4%)    2/150 (1%)   1/98 (1%)  |
|ADJUSTED (b)           |   1.6%         0.0%         0.0%        10.0%      |   3.6%         6.3%         2.1%        10.0%      |
|TERMINAL (d)           |  1/63 (2%)    0/42 (0%)    0/97 (0%)    0/0        |  3/84 (4%)    2/32 (6%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |   727 (T)      ---          ---          676       |   729 (T)      729 (T)      715          634       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.157      P=0.581N     P=0.414N     P=0.118    |  P=0.334      P=0.451      P=0.471N     P=0.093    |
|INCIDENTAL TUMOR       |  P=0.438      P=0.581N     P=0.414N     P=0.500    |  P=0.568N     P=0.451      P=0.204N     P=0.866    |
|LOGISTIC REGRESSION    |  P=0.391      P=0.581N     P=0.414N     P=0.414    |  P=0.628      P=0.451      P=0.412N     P=0.577    |
|COCHRAN-ARMITAGE       |  P=0.582                                           |  P=0.203N                                          |
|FISHER EXACT           |               P=0.671N     P=0.400N     P=0.751N   |               P=0.541      P=0.316N     P=0.318N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/99 (1%)    0/47 (0%)    5/145 (3%)   3/91 (3%)  |  3/99 (3%)    1/50 (2%)    4/150 (3%)   0/87 (0%)  |
|ADJUSTED (b)           |   1.6%         0.0%         4.9%        11.4%      |   3.5%         3.1%         4.5%         0.0%      |
|TERMINAL (d)           |  1/62 (2%)    0/41 (0%)    4/96 (4%)    0/0        |  2/84 (2%)    1/32 (3%)    4/88 (5%)    0/0        |
|FIRST INCIDENCE (DAYS) |   727 (T)      ---          548          526       |   708          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.582N     P=0.236      P=0.013 *  |  P=0.660      P=0.670N     P=0.528        (e)      |
|INCIDENTAL TUMOR       |  P=0.135      P=0.582N     P=0.253      P=0.287    |  P=0.738N     P=0.539N     P=0.642      P=0.464N   |
|LOGISTIC REGRESSION    |  P=0.116      P=0.582N     P=0.217      P=0.179    |  P=0.733      P=0.624N     P=0.597      P=0.930N   |
|COCHRAN-ARMITAGE       |  P=0.198                                           |  P=0.126N                                          |
|FISHER EXACT           |               P=0.678N     P=0.221      P=0.279    |               P=0.589N     P=0.577N     P=0.149N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  14
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/100 (1%)   2/50 (4%)    0/150 (0%)   0/98 (0%)  |
|ADJUSTED (b)           |                                                    |   1.2%         6.3%         0.0%         0.0%      |
|TERMINAL (d)           |                                                    |  1/84 (1%)    2/32 (6%)    0/88 (0%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.581N     P=0.190      P=0.491N       (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.581N     P=0.190      P=0.491N       (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.581N     P=0.190      P=0.491N       (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.170N                                          |
|FISHER EXACT           |                                                    |               P=0.258      P=0.400N     P=0.505N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/100 (2%)   3/50 (6%)    1/150 (1%)   0/98 (0%)  |
|ADJUSTED (b)           |                                                    |   2.4%         8.4%         1.1%         0.0%      |
|TERMINAL (d)           |                                                    |  2/84 (2%)    2/32 (6%)    1/88 (1%)    0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      621          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.451N     P=0.143      P=0.484N       (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.205N     P=0.225      P=0.484N       (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.209N     P=0.196      P=0.484N       (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.071N                                          |
|FISHER EXACT           |                                                    |               P=0.207      P=0.351N     P=0.254N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  15
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/100 (0%)   0/49 (0%)    1/150 (1%)   0/100 (0%) |  1/100 (1%)   1/50 (2%)    2/150 (1%)   1/98 (1%)  |
|ADJUSTED (b)           |   0.0%         0.0%         1.0%         0.0%      |   1.2%         3.1%         2.3%         1.3%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    1/97 (1%)    0/0        |  1/84 (1%)    1/32 (3%)    2/88 (2%)    0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          727 (T)      ---       |   729 (T)      729 (T)      729 (T)      477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.885        (e)        P=0.586        (e)      |  P=0.176      P=0.533      P=0.516      P=0.454    |
|INCIDENTAL TUMOR       |  P=0.885        (e)        P=0.586        (e)      |  P=0.533      P=0.533      P=0.516      P=0.900    |
|LOGISTIC REGRESSION    |  P=0.885        (e)        P=0.586        (e)      |  P=0.620      P=0.533      P=0.516      P=0.827N   |
|COCHRAN-ARMITAGE       |  P=0.770N                                          |  P=0.584N                                          |
|FISHER EXACT           |                 (e)        P=0.600        (e)      |               P=0.557      P=0.649      P=0.746    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/100 (11%)  7/49 (14%)  15/150 (10%)  2/100 (2%) |  2/100 (2%)   4/50 (8%)   11/150 (7%)   0/98 (0%)  |
|ADJUSTED (b)           |  15.7%        16.2%        13.0%         5.8%      |   2.4%        11.4%        10.4%         0.0%      |
|TERMINAL (d)           |  6/63 (10%)   6/42 (14%)   5/97 (5%)    0/0        |  2/84 (2%)    3/32 (9%)    5/88 (6%)    0/0        |
|FIRST INCIDENCE (DAYS) |   655          605          561          587       |   729 (T)      621          624          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.464      P=0.595N     P=0.450N     P=0.234    |  P=0.139      P=0.050      P=0.025 *      (e)      |
|INCIDENTAL TUMOR       |  P=0.005N**   P=0.285      P=0.429N     P=0.081N   |  P=0.345N     P=0.087      P=0.127        (e)      |
|LOGISTIC REGRESSION    |  P=0.009N**   P=0.431      P=0.512N     P=0.290N   |  P=0.447N     P=0.079      P=0.058        (e)      |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |  P=0.080N                                          |
|FISHER EXACT           |               P=0.370      P=0.479N     P=0.009N** |               P=0.096      P=0.053      P=0.254N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  16
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/100 (11%)  7/49 (14%)  16/150 (11%)  2/100 (2%) |  3/100 (3%)   5/50 (10%)  13/150 (9%)   1/98 (1%)  |
|ADJUSTED (b)           |  15.7%        16.2%        14.0%         5.8%      |   3.6%        14.5%        12.5%         1.3%      |
|TERMINAL (d)           |  6/63 (10%)   6/42 (14%)   6/97 (6%)    0/0        |  3/84 (4%)    4/32 (13%)   7/88 (8%)    0/0        |
|FIRST INCIDENCE (DAYS) |   655          605          561          587       |   729 (T)      621          624          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.414      P=0.595N     P=0.514N     P=0.234    |  P=0.034 *    P=0.036 *    P=0.022 *    P=0.454    |
|INCIDENTAL TUMOR       |  P=0.006N**   P=0.285      P=0.498N     P=0.081N   |  P=0.467N     P=0.061      P=0.102      P=0.900    |
|LOGISTIC REGRESSION    |  P=0.011N*    P=0.431      P=0.577N     P=0.290N   |  P=0.513N     P=0.061      P=0.059      P=0.675N   |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |  P=0.091N                                          |
|FISHER EXACT           |               P=0.370      P=0.545N     P=0.009N** |               P=0.082      P=0.059      P=0.318N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/100 (2%)   1/49 (2%)    2/150 (1%)   0/100 (0%) |  2/100 (2%)   3/50 (6%)    4/150 (3%)   0/98 (0%)  |
|ADJUSTED (b)           |   2.5%         2.3%         1.9%         0.0%      |   2.3%         7.8%         4.0%         0.0%      |
|TERMINAL (d)           |  0/63 (0%)    0/42 (0%)    1/97 (1%)    0/0        |  1/84 (1%)    1/32 (3%)    2/88 (2%)    0/0        |
|FIRST INCIDENCE (DAYS) |   624          662          702          ---       |   575          490          630          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.507N     P=0.702N     P=0.530N     P=0.581N   |  P=0.608N     P=0.165      P=0.425      P=0.736N   |
|INCIDENTAL TUMOR       |  P=0.101N     P=0.440      P=0.510N     P=0.094N   |  P=0.041N*    P=0.310      P=0.662N     P=0.134N   |
|LOGISTIC REGRESSION    |  P=0.180N     P=0.728      P=0.541N     P=0.268N   |  P=0.064N     P=0.281      P=0.550      P=0.282N   |
|COCHRAN-ARMITAGE       |  P=0.158N                                          |  P=0.090N                                          |
|FISHER EXACT           |               P=0.701      P=0.525N     P=0.249N   |               P=0.207      P=0.544      P=0.254N   |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  17
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 21/100 (21%)  8/49 (16%)  18/150 (12%)  2/100 (2%) | 15/100 (15%) 16/50 (32%)  17/150 (11%)  0/98 (0%)  |
|ADJUSTED (b)           |  26.7%        17.7%        15.3%        12.2%      |  16.7%        37.3%        15.1%         0.0%      |
|TERMINAL (d)           |  9/63 (14%)   5/42 (12%)   6/97 (6%)    0/0        | 10/84 (12%)   6/32 (19%)   6/88 (7%)    0/0        |
|FIRST INCIDENCE (DAYS) |   554          597          548          461       |   492          490          546          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.186N     P=0.159N     P=0.042N*    P=0.536N   |  P=0.141N     P=0.004 **   P=0.524N     P=0.378N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.533      P=0.020N*    P<0.001N** |  P<0.001N**   P=0.058      P=0.059N     P<0.001N** |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.574      P=0.045N*    P=0.002N** |  P<0.001N**   P=0.019 *    P=0.228N     P=0.003N** |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.329N     P=0.042N*    P<0.001N** |               P=0.015 *    P=0.254N     P<0.001N** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/100 (19%)  7/49 (14%)  16/150 (11%)  2/100 (2%) | 13/100 (13%) 13/50 (26%)  13/150 (9%)   0/98 (0%)  |
|ADJUSTED (b)           |  24.9%        15.8%        13.6%        12.2%      |  14.7%        31.6%        11.4%         0.0%      |
|TERMINAL (d)           |  9/63 (14%)   5/42 (12%)   5/97 (5%)    0/0        |  9/84 (11%)   5/32 (16%)   4/88 (5%)    0/0        |
|FIRST INCIDENCE (DAYS) |   554          597          548          461       |   492          512          546          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.238N     P=0.151N     P=0.047N*    P=0.659    |  P=0.141N     P=0.013 *    P=0.411N     P=0.513N   |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.551N     P=0.026N*    P<0.001N** |  P<0.001N**   P=0.127      P=0.046N*    P=0.007N** |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.501N     P=0.053N     P=0.007N** |  P<0.001N**   P=0.043 *    P=0.167N     P=0.020N*  |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.320N     P=0.048N*    P<0.001N** |               P=0.042 *    P=0.187N     P<0.001N** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  18
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 58/100 (58%) 37/49 (76%) 143/150 (95%) 90/100 (90%)| 44/100 (44%) 22/50 (44%) 128/150 (85%) 87/98 (89%) |
|ADJUSTED (b)           |  72.0%        80.4%       100.0%       100.0%      |  49.4%        58.9%        94.0%       100.0%      |
|TERMINAL (d)           | 41/63 (65%)  33/42 (79%)  97/97 (100%)  0/0        | 39/84 (46%)  17/32 (53%)  80/88 (91%)   0/0        |
|FIRST INCIDENCE (DAYS) |   531          307          391          314       |   548          621          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.544N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.141      P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.068      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.499      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.042 *    P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.386      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.027 *    P<0.001 **   P<0.001 ** |               P=0.570N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 53/100 (53%) 20/49 (41%) 116/150 (77%) 72/100 (72%)| 26/100 (26%) 26/50 (52%) 108/150 (72%) 64/98 (65%) |
|ADJUSTED (b)           |  61.2%        43.5%        85.2%       100.0%      |  28.1%        56.3%        77.0%        97.1%      |
|TERMINAL (d)           | 30/63 (48%)  16/42 (38%)  77/97 (79%)   0/0        | 18/84 (21%)  12/32 (38%)  56/88 (64%)   0/0        |
|FIRST INCIDENCE (DAYS) |   447          597          391          314       |   451          490          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.016N*    P=0.004 **   P<0.001 ** |  P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.284N     P<0.001 **   P=0.071    |  P<0.001 **   P=0.013 *    P<0.001 **   P=0.089    |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.235N     P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.005 **   P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.110N     P<0.001 **   P=0.004 ** |               P=0.002 **   P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/10/94                     EXPERIMENT: 05077 TEST: 02                                                 PAGE  19
                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- FIREMASTER FF-1 POLYBROMINATED BIPHEN
 
                                                 MALE TERMINAL SACRIFICE AT 104 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        3 PPM        10 PPM       30 PPM    |   0 PPM        3 PPM        10 PPM       30 PPM    |
|                       |   10-0         1-1          10-3         10-10     |   10-0         1-1          10-3         10-10     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 84/100 (84%) 42/49 (86%) 144/150 (96%) 98/100 (98%)| 60/100 (60%) 36/50 (72%) 145/150 (97%) 94/98 (96%) |
|ADJUSTED (b)           |  90.3%        89.4%       100.0%       100.0%      |  63.8%        78.1%        98.6%       100.0%      |
|TERMINAL (d)           | 54/63 (86%)  37/42 (88%)  97/97 (100%)  0/0        | 50/84 (60%)  22/32 (69%)  86/88 (98%)   0/0        |
|FIRST INCIDENCE (DAYS) |   447          307          391          314       |   451          490          435          291       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.027N*    P=0.123      P<0.001 ** |  P<0.001 **   P=0.006 **   P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.459      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.160      P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.531      P<0.001 **   P<0.001 ** |  P<0.001 **   P=0.077      P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.496      P=0.001 **   P<0.001 ** |               P=0.103      P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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. 
 (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).

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