Share This:
https://ntp.niehs.nih.gov/go/2202

TDMS Study 05127-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                              BARIUM CHLORIDE DIHYDRATE                              DATE: 09/16/94       
EXPERIMENT: 05127 TEST: 01                                                                                     TIME: 19:05:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES55115            ROUTE: DOSED WATER                                                                 NTP C#: C61074       
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 10326279        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                              BARIUM CHLORIDE DIHYDRATE                              DATE: 09/16/94      
EXPERIMENT: 05127 TEST: 01                                                                                     TIME: 19:05:35      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES55115            ROUTE: DOSED WATER                                                                 NTP C#: C61074      
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 10326279       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             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
                                                    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: Mason                                              BARIUM CHLORIDE DIHYDRATE                              DATE: 09/16/94       
EXPERIMENT: 05127 TEST: 01                                                                                     TIME: 19:05:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01ES55115            ROUTE: DOSED WATER                                                                 NTP C#: C61074       
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 10326279        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                   IN THE ANALYSIS OF THE STUDY OF BARIUM CHLORIDE DIHYDRATE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Skin                          Fibroma
                             Uterus                        Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   1
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    3/59 (5%)    1/59 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.3%         0.0%         0.0%         3.0%      |   3.2%         8.3%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    1/33 (3%)  |  1/31 (3%)    3/36 (8%)    1/38 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   723          ---          ---          730 (T)   |   737 (T)      737 (T)      737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.632      P=0.428N     P=0.447N     P=0.669N   |  P=0.168N     P=0.359      P=0.716N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.515      P=0.628N     P=0.576N     P=0.700    |  P=0.168N     P=0.359      P=0.716N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.603      P=0.479N     P=0.473N     P=0.727N   |  P=0.168N     P=0.359      P=0.716N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.577                                           |  P=0.176N                                          |
|FISHER EXACT           |               P=0.496N     P=0.496N     P=0.748N   |               P=0.303      P=0.748      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/59 (19%)   9/60 (15%)  11/59 (19%)   6/60 (10%) |  2/60 (3%)    4/59 (7%)    2/59 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |  40.2%        27.0%        34.0%        18.2%      |   6.5%        10.3%         5.3%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  7/22 (32%)   7/31 (23%)   9/29 (31%)   6/33 (18%) |  2/31 (6%)    3/36 (8%)    2/38 (5%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   691          673          452 (I)      730 (T)   |   737 (T)      647          737 (T)      669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046N*    P=0.180N     P=0.347N     P=0.033N*  |  P=0.233N     P=0.413      P=0.620N     P=0.474N   |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.346N     P=0.493N     P=0.098N   |  P=0.229N     P=0.414      P=0.620N     P=0.456N   |
|LOGISTIC REGRESSION    |  P=0.117N     P=0.319N     P=0.538N     P=0.085N   |  P=0.227N     P=0.401      P=0.620N     P=0.473N   |
|COCHRAN-ARMITAGE       |  P=0.145N                                          |  P=0.241N                                          |
|FISHER EXACT           |               P=0.387N     P=0.593N     P=0.139N   |               P=0.332      P=0.684      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   2
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/59 (3%)    2/60 (3%)    2/59 (3%)    0/60 (0%)  |  0/60 (0%)    0/59 (0%)    0/59 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   6.7%         5.6%         6.9%         0.0%      |   0.0%         0.0%         0.0%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    1/31 (3%)    2/29 (7%)    0/33 (0%)  |  0/31 (0%)    0/36 (0%)    0/38 (0%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   605          653          730 (T)      ---       |   ---          ---          ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.124N     P=0.638N     P=0.618N     P=0.200N   |  P=0.186        (e)          (e)        P=0.506    |
|INCIDENTAL TUMOR       |  P=0.130N     P=0.654N     P=0.618N     P=0.130N   |  P=0.186        (e)          (e)        P=0.506    |
|LOGISTIC REGRESSION    |  P=0.156N     P=0.684N     P=0.681N     P=0.234N   |  P=0.186        (e)          (e)        P=0.506    |
|COCHRAN-ARMITAGE       |  P=0.160N                                          |  P=0.195                                           |
|FISHER EXACT           |               P=0.684N     P=0.691N     P=0.244N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/59 (22%)  11/60 (18%)  13/59 (22%)   6/60 (10%) |  2/60 (3%)    5/59 (8%)    2/59 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  45.5%        31.8%        40.6%        18.2%      |   6.5%        13.0%         5.3%         5.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  8/22 (36%)   8/31 (26%)  11/29 (38%)   6/33 (18%) |  2/31 (6%)    4/36 (11%)   2/38 (5%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   605          653          452 (I)      730 (T)   |   737 (T)      647          737 (T)      669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.014N*    P=0.181N     P=0.321N     P=0.011N*  |  P=0.355N     P=0.285      P=0.620N     P=0.671N   |
|INCIDENTAL TUMOR       |  P=0.037N*    P=0.336N     P=0.455N     P=0.028N*  |  P=0.347N     P=0.286      P=0.620N     P=0.657N   |
|LOGISTIC REGRESSION    |  P=0.048N*    P=0.347N     P=0.531N     P=0.042N*  |  P=0.344N     P=0.277      P=0.620N     P=0.665N   |
|COCHRAN-ARMITAGE       |  P=0.065N                                          |  P=0.362N                                          |
|FISHER EXACT           |               P=0.392N     P=0.588N     P=0.061N   |               P=0.213      P=0.684      P=0.691N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   3
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  2/60 (3%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         3.0%      |   5.3%         0.0%         1.9%         1.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    1/33 (3%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          730 (T)   |   652          ---          458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.227        (e)          (e)        P=0.581    |  P=0.524N     P=0.196N     P=0.479N     P=0.479N   |
|INCIDENTAL TUMOR       |  P=0.227        (e)          (e)        P=0.581    |  P=0.506N     P=0.166N     P=0.708      P=0.426N   |
|LOGISTIC REGRESSION    |  P=0.227        (e)          (e)        P=0.581    |  P=0.554N     P=0.238N     P=0.508N     P=0.533N   |
|COCHRAN-ARMITAGE       |  P=0.194                                           |  P=0.527N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.248N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    2/59 (3%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    1/59 (2%)    0/60 (0%)    2/57 (4%)  |
|ADJUSTED (b)           |   4.5%         6.7%         6.9%         0.0%      |   0.0%         2.8%         0.0%         6.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    2/30 (7%)    2/29 (7%)    0/33 (0%)  |  0/31 (0%)    1/36 (3%)    0/39 (0%)    2/30 (7%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      730 (T)      730 (T)      ---       |   ---          737 (T)      ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.201N     P=0.608      P=0.597      P=0.419N   |  P=0.129      P=0.530        (e)        P=0.231    |
|INCIDENTAL TUMOR       |  P=0.201N     P=0.608      P=0.597      P=0.419N   |  P=0.129      P=0.530        (e)        P=0.231    |
|LOGISTIC REGRESSION    |  P=0.201N     P=0.608      P=0.597      P=0.419N   |  P=0.129      P=0.530        (e)        P=0.231    |
|COCHRAN-ARMITAGE       |  P=0.279N                                          |  P=0.140                                           |
|FISHER EXACT           |               P=0.500      P=0.506      P=0.496N   |               P=0.496        (e)        P=0.235    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   4
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    1/59 (2%)    0/60 (0%)    1/60 (2%)  |  3/60 (5%)    3/59 (5%)    0/60 (0%)    1/57 (2%)  |
|ADJUSTED (b)           |   2.2%         3.3%         0.0%         3.0%      |   9.7%         7.1%         0.0%         3.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    1/30 (3%)    0/29 (0%)    1/33 (3%)  |  3/31 (10%)   1/36 (3%)    0/39 (0%)    1/30 (3%)  |
|FIRST INCIDENCE (DAYS) |   565          730 (T)      ---          730 (T)   |   737 (T)      647          ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.557N     P=0.726N     P=0.500N     P=0.722N   |  P=0.124N     P=0.572N     P=0.084N     P=0.316N   |
|INCIDENTAL TUMOR       |  P=0.501N     P=0.679N     P=0.500N     P=0.634N   |  P=0.131N     P=0.580N     P=0.084N     P=0.316N   |
|LOGISTIC REGRESSION    |  P=0.601N     P=0.762N     P=0.515N     P=0.758N   |  P=0.126N     P=0.609N     P=0.084N     P=0.316N   |
|COCHRAN-ARMITAGE       |  P=0.601N                                          |  P=0.134N                                          |
|FISHER EXACT           |               P=0.752N     P=0.496N     P=0.748N   |               P=0.652      P=0.122N     P=0.329N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/59 (3%)    3/59 (5%)    2/60 (3%)    1/60 (2%)  |  3/60 (5%)    4/59 (7%)    0/60 (0%)    3/57 (5%)  |
|ADJUSTED (b)           |   6.6%        10.0%         6.9%         3.0%      |   9.7%         9.7%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    3/30 (10%)   2/29 (7%)    1/33 (3%)  |  3/31 (10%)   2/36 (6%)    0/39 (0%)    3/30 (10%) |
|FIRST INCIDENCE (DAYS) |   565          730 (T)      730 (T)      730 (T)   |   737 (T)      647          ---          737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.207N     P=0.612      P=0.618N     P=0.412N   |  P=0.448N     P=0.598      P=0.084N     P=0.650    |
|INCIDENTAL TUMOR       |  P=0.185N     P=0.648      P=0.618N     P=0.330N   |  P=0.447N     P=0.592      P=0.084N     P=0.650    |
|LOGISTIC REGRESSION    |  P=0.281N     P=0.508      P=0.677N     P=0.493N   |  P=0.443N     P=0.570      P=0.084N     P=0.650    |
|COCHRAN-ARMITAGE       |  P=0.293N                                          |  P=0.453N                                          |
|FISHER EXACT           |               P=0.500      P=0.684N     P=0.494N   |               P=0.491      P=0.122N     P=0.636    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   5
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/55 (5%)    2/58 (3%)    5/58 (9%)    5/59 (8%)  |  0/59 (0%)    1/58 (2%)    1/59 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |  10.9%         5.9%        15.7%        14.0%      |   0.0%         2.8%         2.6%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    1/31 (3%)    4/29 (14%)   3/33 (9%)  |  0/31 (0%)    1/36 (3%)    1/39 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   708          673          591          633       |   ---          737 (T)      737 (T)      707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.281      P=0.429N     P=0.478      P=0.517    |  P=0.392      P=0.530      P=0.546      P=0.530    |
|INCIDENTAL TUMOR       |  P=0.192      P=0.639N     P=0.412      P=0.291    |  P=0.412      P=0.530      P=0.546      P=0.564    |
|LOGISTIC REGRESSION    |  P=0.203      P=0.473N     P=0.401      P=0.396    |  P=0.398      P=0.530      P=0.546      P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.207                                           |  P=0.395                                           |
|FISHER EXACT           |               P=0.475N     P=0.388      P=0.398    |               P=0.496      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/55 (4%)    0/58 (0%)    2/58 (3%)    0/59 (0%)  |  0/59 (0%)    2/58 (3%)    0/59 (0%)    0/59 (0%)  |
|ADJUSTED (b)           |   6.8%         0.0%         6.9%         0.0%      |   0.0%         5.6%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    0/31 (0%)    2/29 (7%)    0/33 (0%)  |  0/31 (0%)    2/36 (6%)    0/39 (0%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          ---          730 (T)      ---       |   ---          737 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.205N     P=0.616N     P=0.198N   |  P=0.353N     P=0.272        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.184N     P=0.135N     P=0.590N     P=0.106N   |  P=0.353N     P=0.272        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.259N     P=0.226N     P=0.668N     P=0.224N   |  P=0.353N     P=0.272        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.259N                                          |  P=0.352N                                          |
|FISHER EXACT           |               P=0.235N     P=0.671N     P=0.231N   |               P=0.244        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   6
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/55 (9%)    2/58 (3%)    6/58 (10%)   5/59 (8%)  |  0/59 (0%)    3/58 (5%)    1/59 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |  17.1%         5.9%        19.1%        14.0%      |   0.0%         8.3%         2.6%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/22 (9%)    1/31 (3%)    5/29 (17%)   3/33 (9%)  |  0/31 (0%)    3/36 (8%)    1/39 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          673          591          633       |   ---          737 (T)      737 (T)      707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.507      P=0.163N     P=0.607N     P=0.461N   |  P=0.613N     P=0.148      P=0.546      P=0.530    |
|INCIDENTAL TUMOR       |  P=0.438      P=0.237N     P=0.605      P=0.603N   |  P=0.597N     P=0.148      P=0.546      P=0.564    |
|LOGISTIC REGRESSION    |  P=0.406      P=0.195N     P=0.554      P=0.590N   |  P=0.602N     P=0.148      P=0.546      P=0.509    |
|COCHRAN-ARMITAGE       |  P=0.409                                           |  P=0.604N                                          |
|FISHER EXACT           |               P=0.198N     P=0.538      P=0.583N   |               P=0.119      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    2/60 (3%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.6%         5.6%         2.6%         3.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  0/31 (0%)    2/36 (6%)    1/39 (3%)    1/32 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   645          737 (T)      737 (T)      737 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.510N     P=0.556      P=0.729N     P=0.746N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.502N     P=0.571      P=0.657      P=0.722N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.501N     P=0.537      P=0.754N     P=0.752N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.512N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.752N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   7
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  1/60 (2%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.3%         5.3%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  0/31 (0%)    1/36 (3%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   589          713          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.161N     P=0.548      P=0.500N     P=0.491N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.192N     P=0.292      P=0.669N     P=0.612N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.165N     P=0.515      P=0.505N     P=0.518N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.168N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.4%         5.3%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  1/31 (3%)    1/36 (3%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   589          713          668          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.113N     P=0.641N     P=0.455N     P=0.231N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.135N     P=0.571      P=0.714N     P=0.296N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.117N     P=0.669N     P=0.496N     P=0.235N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.121N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.691N     P=0.500N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   8
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    1/60 (2%)    0/60 (0%)  | 15/60 (25%)  19/60 (32%)  12/60 (20%)  11/60 (18%) |
|ADJUSTED (b)           |   7.6%         9.7%         3.4%         0.0%      |  45.2%        48.4%        29.8%        32.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    3/31 (10%)   1/29 (3%)    0/33 (0%)  | 13/31 (42%)  16/36 (44%)  11/39 (28%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   703          730 (T)      730 (T)      ---       |   658          647          520          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.059N     P=0.632      P=0.416N     P=0.187N   |  P=0.080N     P=0.478      P=0.132N     P=0.203N   |
|INCIDENTAL TUMOR       |  P=0.076N     P=0.564      P=0.485N     P=0.304N   |  P=0.074N     P=0.496      P=0.185N     P=0.173N   |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.553      P=0.464N     P=0.226N   |  P=0.066N     P=0.518      P=0.209N     P=0.150N   |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |  P=0.101N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.248N   |               P=0.272      P=0.331N     P=0.253N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    1/60 (2%)    0/60 (0%)  | 16/60 (27%)  21/60 (35%)  12/60 (20%)  11/60 (18%) |
|ADJUSTED (b)           |   7.6%         9.7%         3.4%         0.0%      |  46.4%        52.3%        29.8%        32.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    3/31 (10%)   1/29 (3%)    0/33 (0%)  | 13/31 (42%)  17/36 (47%)  11/39 (28%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   703          730 (T)      730 (T)      ---       |   589          647          520          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.059N     P=0.632      P=0.416N     P=0.187N   |  P=0.041N*    P=0.415      P=0.094N     P=0.149N   |
|INCIDENTAL TUMOR       |  P=0.076N     P=0.564      P=0.485N     P=0.304N   |  P=0.039N*    P=0.346      P=0.155N     P=0.138N   |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.553      P=0.464N     P=0.226N   |  P=0.032N*    P=0.418      P=0.164N     P=0.109N   |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |  P=0.054N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.248N   |               P=0.215      P=0.259N     P=0.191N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE   9
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    1/60 (2%)    0/60 (0%)  | 17/60 (28%)  21/60 (35%)  13/60 (22%)  11/60 (18%) |
|ADJUSTED (b)           |   7.6%         9.7%         3.4%         0.0%      |  49.4%        52.3%        31.5%        32.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    3/31 (10%)   1/29 (3%)    0/33 (0%)  | 14/31 (45%)  17/36 (47%)  11/39 (28%)   9/32 (28%) |
|FIRST INCIDENCE (DAYS) |   703          730 (T)      730 (T)      ---       |   589          647          520          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.059N     P=0.632      P=0.416N     P=0.187N   |  P=0.031N*    P=0.502      P=0.094N     P=0.104N   |
|INCIDENTAL TUMOR       |  P=0.076N     P=0.564      P=0.485N     P=0.304N   |  P=0.029N*    P=0.436      P=0.187N     P=0.095N   |
|LOGISTIC REGRESSION    |  P=0.076N     P=0.553      P=0.464N     P=0.226N   |  P=0.024N*    P=0.515      P=0.167N     P=0.071N   |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |  P=0.042N*                                         |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.248N   |               P=0.278      P=0.264N     P=0.140N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/58 (3%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.7%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    1/29 (3%)    0/29 (0%)    0/33 (0%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          580          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.321N     P=0.267        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.275N     P=0.317        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.351N     P=0.231        (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.351N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.239        (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  10
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/55 (5%)    4/58 (7%)    1/59 (2%)    3/60 (5%)  |  1/59 (2%)    0/57 (0%)    1/59 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.6%        12.9%         3.4%         9.1%      |   3.2%         0.0%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/22 (14%)   4/31 (13%)   1/29 (3%)    3/33 (9%)  |  1/31 (3%)    0/36 (0%)    1/39 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      730 (T)      730 (T)      730 (T)   |   737 (T)      ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.312N     P=0.630N     P=0.210N     P=0.465N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.312N     P=0.630N     P=0.210N     P=0.465N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.312N     P=0.630N     P=0.210N     P=0.465N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.421N                                          |  P=0.419N                                          |
|FISHER EXACT           |               P=0.530      P=0.283N     P=0.618N   |               P=0.509N     P=0.752N     P=0.496N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/55 (7%)    4/58 (7%)    1/59 (2%)    3/60 (5%)  |  1/59 (2%)    0/57 (0%)    1/59 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  18.2%        12.9%         3.4%         9.1%      |   3.2%         0.0%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/22 (18%)   4/31 (13%)   1/29 (3%)    3/33 (9%)  |  1/31 (3%)    0/36 (0%)    1/39 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      730 (T)      730 (T)      730 (T)   |   737 (T)      ---          737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.199N     P=0.445N     P=0.103N     P=0.283N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|INCIDENTAL TUMOR       |  P=0.199N     P=0.445N     P=0.103N     P=0.283N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|LOGISTIC REGRESSION    |  P=0.199N     P=0.445N     P=0.103N     P=0.283N   |  P=0.422N     P=0.470N     P=0.710N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.297N                                          |  P=0.419N                                          |
|FISHER EXACT           |               P=0.612N     P=0.161N     P=0.451N   |               P=0.509N     P=0.752N     P=0.496N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  11
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/58 (40%)  25/55 (45%)  20/59 (34%)  23/56 (41%) | 30/58 (52%)  26/58 (45%)  30/59 (51%)  26/60 (43%) |
|ADJUSTED (b)           |  71.6%        56.7%        49.1%        54.0%      |  72.5%        61.5%        65.8%        58.9%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   3/10 (30%)   2/10 (20%) |  1/10 (10%)   0/10 (0%)    3/10 (30%)   2/10 (20%) |
|TERMINAL (d)           | 14/22 (64%)  12/29 (41%)  10/29 (34%)  14/32 (44%) | 20/31 (65%)  20/36 (56%)  23/38 (61%)  15/32 (47%) |
|FIRST INCIDENCE (DAYS) |   452 (I)      452 (I)      452 (I)      452 (I)   |   458 (I)      647          430          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.443N     P=0.128N     P=0.202N   |  P=0.334N     P=0.094N     P=0.249N     P=0.232N   |
|INCIDENTAL TUMOR       |  P=0.435N     P=0.416      P=0.255N     P=0.384N   |  P=0.266N     P=0.294N     P=0.568      P=0.254N   |
|LOGISTIC REGRESSION    |  P=0.451N     P=0.346      P=0.288N     P=0.533    |  P=0.224N     P=0.287N     P=0.512N     P=0.190N   |
|COCHRAN-ARMITAGE       |  P=0.462N                                          |  P=0.275N                                          |
|FISHER EXACT           |               P=0.333      P=0.325N     P=0.515    |               P=0.289N     P=0.536N     P=0.233N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/58 (2%)    1/55 (2%)    1/59 (2%)    2/56 (4%)  |  4/58 (7%)    6/58 (10%)   4/59 (7%)    5/60 (8%)  |
|ADJUSTED (b)           |   4.5%         3.0%         2.1%         5.5%      |  12.9%        15.3%        10.5%        14.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    0/29 (0%)    0/29 (0%)    1/32 (3%)  |  4/31 (13%)   5/36 (14%)   4/38 (11%)   3/32 (9%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      723          528          620       |   737 (T)      428          737 (T)      669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.402      P=0.688N     P=0.730N     P=0.583    |  P=0.538      P=0.458      P=0.528N     P=0.538    |
|INCIDENTAL TUMOR       |  P=0.316      P=0.722      P=0.696N     P=0.649    |  P=0.552      P=0.456      P=0.528N     P=0.559    |
|LOGISTIC REGRESSION    |  P=0.345      P=0.746N     P=0.763N     P=0.497    |  P=0.562N     P=0.418      P=0.528N     P=0.560    |
|COCHRAN-ARMITAGE       |  P=0.344                                           |  P=0.556                                           |
|FISHER EXACT           |               P=0.739      P=0.748N     P=0.487    |               P=0.371      P=0.632N     P=0.522    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  12
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/58 (41%)  26/55 (47%)  21/59 (36%)  25/56 (45%) | 34/58 (59%)  31/58 (53%)  33/59 (56%)  31/60 (52%) |
|ADJUSTED (b)           |  75.1%        58.0%        50.1%        57.6%      |  82.5%        71.6%        72.7%        67.9%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   3/10 (30%)   2/10 (20%) |  1/10 (10%)   0/10 (0%)    3/10 (30%)   2/10 (20%) |
|TERMINAL (d)           | 15/22 (68%)  12/29 (41%)  10/29 (34%)  15/32 (47%) | 24/31 (77%)  24/36 (67%)  26/38 (68%)  18/32 (56%) |
|FIRST INCIDENCE (DAYS) |   452 (I)      452 (I)      452 (I)      452 (I)   |   458 (I)      428          430          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.231N     P=0.423N     P=0.127N     P=0.239N   |  P=0.365N     P=0.100N     P=0.155N     P=0.271N   |
|INCIDENTAL TUMOR       |  P=0.527N     P=0.402      P=0.239N     P=0.412N   |  P=0.284N     P=0.317N     P=0.452N     P=0.285N   |
|LOGISTIC REGRESSION    |  P=0.535N     P=0.344      P=0.290N     P=0.453    |  P=0.251N     P=0.184N     P=0.423N     P=0.216N   |
|COCHRAN-ARMITAGE       |  P=0.526                                           |  P=0.296N                                          |
|FISHER EXACT           |               P=0.330      P=0.325N     P=0.435    |               P=0.354N     P=0.457N     P=0.283N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.5%         0.0%         0.0%         6.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    0/31 (0%)    0/29 (0%)    2/33 (6%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      ---          ---          730 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.295      P=0.432N     P=0.445N     P=0.641    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.295      P=0.432N     P=0.445N     P=0.641    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.295      P=0.432N     P=0.445N     P=0.641    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.232                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  13
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  4/60 (7%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.4%         2.9%      |  12.9%         2.8%         0.0%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    1/29 (3%)    0/33 (0%)  |  4/31 (13%)   1/36 (3%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          730 (T)      726       |   737 (T)      737 (T)      ---          707       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.280        (e)        P=0.555      P=0.587    |  P=0.103N     P=0.136N     P=0.038N*    P=0.165N   |
|INCIDENTAL TUMOR       |  P=0.166        (e)        P=0.555      P=0.261    |  P=0.108N     P=0.136N     P=0.038N*    P=0.155N   |
|LOGISTIC REGRESSION    |  P=0.250        (e)        P=0.555      P=0.532    |  P=0.101N     P=0.136N     P=0.038N*    P=0.149N   |
|COCHRAN-ARMITAGE       |  P=0.225                                           |  P=0.114N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |               P=0.182N     P=0.059N     P=0.182N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.8%         9.7%         0.0%         0.0%      |   0.0%         2.8%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    3/31 (10%)   0/29 (0%)    0/33 (0%)  |  0/31 (0%)    1/36 (3%)    1/39 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          730 (T)      ---          ---       |   ---          737 (T)      737 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.090N     P=0.424      P=0.459N     P=0.446N   |  P=0.577N     P=0.530      P=0.546        (e)      |
|INCIDENTAL TUMOR       |  P=0.122N     P=0.334      P=0.586N     P=0.739N   |  P=0.577N     P=0.530      P=0.546        (e)      |
|LOGISTIC REGRESSION    |  P=0.109N     P=0.350      P=0.487N     P=0.493N   |  P=0.577N     P=0.530      P=0.546        (e)      |
|COCHRAN-ARMITAGE       |  P=0.128N                                          |  P=0.575N                                          |
|FISHER EXACT           |               P=0.309      P=0.500N     P=0.500N   |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  14
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   5.7%         0.0%         0.0%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  1/31 (3%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   645          ---          ---          650       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.479N     P=0.204N     P=0.209N     P=0.474N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.464N     P=0.190N     P=0.343N     P=0.422N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.481N     P=0.222N     P=0.228N     P=0.489N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.485N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248N     P=0.248N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.1%         0.0%         2.7%         6.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/22 (9%)    0/31 (0%)    0/29 (0%)    2/33 (6%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      ---          704          730 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.527      P=0.166N     P=0.412N     P=0.542N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.458      P=0.166N     P=0.485N     P=0.542N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.470      P=0.166N     P=0.463N     P=0.542N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.440                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  15
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    1/60 (2%)    2/60 (3%)  |  2/60 (3%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  12.6%         9.7%         2.7%         6.1%      |   5.7%         2.8%         2.6%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/22 (9%)    3/31 (10%)   0/29 (0%)    2/33 (6%)  |  1/31 (3%)    1/36 (3%)    1/39 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   712          730 (T)      704          730 (T)   |   645          737 (T)      737 (T)      650       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.232N     P=0.506N     P=0.226N     P=0.332N   |  P=0.411N     P=0.444N     P=0.441N     P=0.474N   |
|INCIDENTAL TUMOR       |  P=0.318N     P=0.583N     P=0.331N     P=0.450N   |  P=0.401N     P=0.429N     P=0.591N     P=0.422N   |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.583N     P=0.273N     P=0.423N   |  P=0.408N     P=0.463N     P=0.477N     P=0.489N   |
|COCHRAN-ARMITAGE       |  P=0.334N                                          |  P=0.417N                                          |
|FISHER EXACT           |               P=0.660N     P=0.309N     P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         5.7%         1.7%         0.0%      |   3.0%         0.0%         3.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          673          452 (I)      ---       |   692          ---          310          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.405N     P=0.266      P=0.500        (e)      |  P=0.478N     P=0.443N     P=0.530      P=0.472N   |
|INCIDENTAL TUMOR       |  P=0.588N     P=0.102      P=0.500        (e)      |  P=0.599N     P=0.436N     P=0.263      P=0.436N   |
|LOGISTIC REGRESSION    |  P=0.422N     P=0.242      P=0.417        (e)      |  P=0.512N     P=0.486N     P=0.492      P=0.490N   |
|COCHRAN-ARMITAGE       |  P=0.424N                                          |  P=0.485N                                          |
|FISHER EXACT           |               P=0.248      P=0.500        (e)      |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  16
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 43/59 (73%)  48/60 (80%)  50/60 (83%)  44/60 (73%) |                                                    |
|ADJUSTED (b)           |  91.1%        95.9%       100.0%        93.3%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   4/10 (40%)   4/10 (40%)   7/10 (70%) |                                                    |
|TERMINAL (d)           | 18/22 (82%)  29/31 (94%)  29/29 (100%) 30/33 (91%) |                                                    |
|FIRST INCIDENCE (DAYS) |   452 (I)      452 (I)      452 (I)      452 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.085N     P=0.349N     P=0.468N     P=0.092N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.487N     P=0.256      P=0.095      P=0.562N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.515N     P=0.258      P=0.129      P=0.555    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.483N                                          |                                                    |
|FISHER EXACT           |               P=0.242      P=0.123      P=0.560    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/59 (8%)    5/58 (9%)    8/60 (13%)   8/60 (13%) |  6/59 (10%)   8/60 (13%)  10/60 (17%)  10/60 (17%) |
|ADJUSTED (b)           |  13.3%        16.1%        22.1%        24.2%      |  16.4%        19.2%        23.7%        27.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  1/22 (5%)    5/31 (16%)   4/29 (14%)   8/33 (24%) |  4/31 (13%)   4/36 (11%)   8/39 (21%)   7/32 (22%) |
|FIRST INCIDENCE (DAYS) |   565          730 (T)      453 (I)      730 (T)   |   456 (I)      647          458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.308      P=0.514N     P=0.382      P=0.460    |  P=0.181      P=0.514      P=0.332      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.238      P=0.564N     P=0.287      P=0.429    |  P=0.196      P=0.439      P=0.315      P=0.221    |
|LOGISTIC REGRESSION    |  P=0.187      P=0.625N     P=0.294      P=0.296    |  P=0.192      P=0.452      P=0.236      P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.189                                           |  P=0.183                                           |
|FISHER EXACT           |               P=0.618      P=0.290      P=0.290    |               P=0.402      P=0.221      P=0.221    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  17
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/59 (8%)    6/58 (10%)   8/60 (13%)   9/60 (15%) |  6/59 (10%)   8/60 (13%)  10/60 (17%)  10/60 (17%) |
|ADJUSTED (b)           |  13.3%        18.7%        22.1%        25.9%      |  16.4%        19.2%        23.7%        27.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  1/22 (5%)    5/31 (16%)   4/29 (14%)   8/33 (24%) |  4/31 (13%)   4/36 (11%)   8/39 (21%)   7/32 (22%) |
|FIRST INCIDENCE (DAYS) |   565          723          453 (I)      564       |   456 (I)      647          458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.259      P=0.615N     P=0.382      P=0.352    |  P=0.181      P=0.514      P=0.332      P=0.238    |
|INCIDENTAL TUMOR       |  P=0.186      P=0.522      P=0.287      P=0.354    |  P=0.196      P=0.439      P=0.315      P=0.221    |
|LOGISTIC REGRESSION    |  P=0.147      P=0.508      P=0.294      P=0.208    |  P=0.192      P=0.452      P=0.236      P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.150                                           |  P=0.183                                           |
|FISHER EXACT           |               P=0.488      P=0.290      P=0.207    |               P=0.402      P=0.221      P=0.221    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/59 (0%)    0/58 (0%)    2/60 (3%)    1/60 (2%)  |  0/59 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.2%         3.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    1/29 (3%)    1/33 (3%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          453 (I)      730 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.274        (e)        P=0.270      P=0.581    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.274        (e)        P=0.270      P=0.581    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.238        (e)        P=0.228      P=0.581    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.238                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.252      P=0.504    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  18
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    0/58 (0%)    2/60 (3%)    1/60 (2%)  |  1/59 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.5%         0.0%         5.2%         3.0%      |   3.0%         2.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/22 (5%)    0/31 (0%)    1/29 (3%)    1/33 (3%)  |  0/31 (0%)    1/36 (3%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   730 (T)      ---          453 (I)      730 (T)   |   692          737 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.540      P=0.432N     P=0.564      P=0.669N   |  P=0.217N     P=0.711N     P=0.467N     P=0.472N   |
|INCIDENTAL TUMOR       |  P=0.540      P=0.432N     P=0.564      P=0.669N   |  P=0.217N     P=0.693N     P=0.748N     P=0.410N   |
|LOGISTIC REGRESSION    |  P=0.481      P=0.432N     P=0.502      P=0.669N   |  P=0.217N     P=0.732N     P=0.489N     P=0.487N   |
|COCHRAN-ARMITAGE       |  P=0.481                                           |  P=0.223N                                          |
|FISHER EXACT           |               P=0.504N     P=0.506      P=0.748N   |               P=0.748N     P=0.496N     P=0.496N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/60 (25%)   8/60 (13%)  11/60 (18%)  16/60 (27%) |
|ADJUSTED (b)           |                                                    |  36.8%        21.5%        26.2%        40.1%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           |                                                    |  8/31 (26%)   7/36 (19%)   9/39 (23%)  10/32 (31%) |
|FIRST INCIDENCE (DAYS) |                                                    |   456 (I)      707          456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.258      P=0.044N*    P=0.136N     P=0.551    |
|INCIDENTAL TUMOR       |                                                    |  P=0.251      P=0.089N     P=0.264N     P=0.521    |
|LOGISTIC REGRESSION    |                                                    |  P=0.265      P=0.063N     P=0.234N     P=0.529    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.250                                           |
|FISHER EXACT           |                                                    |               P=0.082N     P=0.253N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  19
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%         5.6%         2.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/31 (0%)    2/36 (6%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          737 (T)      627          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.418N     P=0.272      P=0.519        (e)      |
|INCIDENTAL TUMOR       |                                                    |  P=0.444N     P=0.272      P=0.331        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.417N     P=0.272      P=0.497        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.424N                                          |
|FISHER EXACT           |                                                    |               P=0.248      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/60 (25%)  10/60 (17%)  12/60 (20%)  16/60 (27%) |
|ADJUSTED (b)           |                                                    |  36.8%        26.9%        27.8%        40.1%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           |                                                    |  8/31 (26%)   9/36 (25%)   9/39 (23%)  10/32 (31%) |
|FIRST INCIDENCE (DAYS) |                                                    |   456 (I)      707          456 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.317      P=0.105N     P=0.191N     P=0.551    |
|INCIDENTAL TUMOR       |                                                    |  P=0.302      P=0.191N     P=0.377N     P=0.521    |
|LOGISTIC REGRESSION    |                                                    |  P=0.325      P=0.143N     P=0.311N     P=0.529    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.306                                           |
|FISHER EXACT           |                                                    |               P=0.184N     P=0.331N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  20
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    2/60 (3%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         4.4%         2.0%         4.6%      |   2.2%         0.0%         0.0%         2.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/22 (0%)    0/31 (0%)    0/29 (0%)    0/33 (0%)  |  0/31 (0%)    0/36 (0%)    0/39 (0%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          544          520          582       |   575          ---          ---          644       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.267      P=0.244      P=0.504      P=0.240    |  P=0.578      P=0.496N     P=0.509N     P=0.747N   |
|INCIDENTAL TUMOR       |  P=0.328      P=0.284      P=0.557      P=0.397    |  P=0.524        (e)        P=0.669N     P=0.638    |
|LOGISTIC REGRESSION    |  P=0.272      P=0.226      P=0.467      P=0.239    |  P=0.568      P=0.524N     P=0.505N     P=0.750    |
|COCHRAN-ARMITAGE       |  P=0.264                                           |  P=0.575                                           |
|FISHER EXACT           |               P=0.248      P=0.500      P=0.248    |               P=0.500N     P=0.500N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/60 (58%)  25/60 (42%)  26/60 (43%)  15/60 (25%) | 15/60 (25%)  13/60 (22%)   9/60 (15%)   9/60 (15%) |
|ADJUSTED (b)           |  72.7%        56.5%        60.1%        37.0%      |  36.5%        30.9%        20.5%        24.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  9/22 (41%)  13/31 (42%)  12/29 (41%)   8/33 (24%) |  7/31 (23%)   8/36 (22%)   5/39 (13%)   5/32 (16%) |
|FIRST INCIDENCE (DAYS) |   305          520          590          564       |   359          666          462          493       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.031N*    P=0.036N*    P<0.001N** |  P=0.080N     P=0.246N     P=0.074N     P=0.111N   |
|INCIDENTAL TUMOR       |  P=0.003N**   P=0.140N     P=0.200N     P=0.010N** |  P=0.075N     P=0.559N     P=0.237N     P=0.154N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.040N*    P=0.056N     P<0.001N** |  P=0.073N     P=0.349N     P=0.123N     P=0.112N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.082N                                          |
|FISHER EXACT           |               P=0.050N*    P=0.072N     P<0.001N** |               P=0.415N     P=0.127N     P=0.127N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  21
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 52/60 (87%)  57/60 (95%)  56/60 (93%)  52/60 (87%) | 46/60 (77%)  39/60 (65%)  43/60 (72%)  43/60 (72%) |
|ADJUSTED (b)           |  98.1%       100.0%       100.0%       100.0%      |  93.8%        88.6%        85.6%        83.9%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   7/10 (70%)   8/10 (80%)   8/10 (80%) |  3/10 (30%)   0/10 (0%)    4/10 (40%)   5/10 (50%) |
|TERMINAL (d)           | 21/22 (95%)  31/31 (100%) 29/29 (100%) 33/33 (100%)| 28/31 (90%)  31/36 (86%)  32/39 (82%)  24/32 (75%) |
|FIRST INCIDENCE (DAYS) |   452 (I)      452 (I)      452 (I)      452 (I)   |   456 (I)      647          310          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046N*    P=0.299N     P=0.279N     P=0.050N*  |  P=0.449N     P=0.013N*    P=0.054N     P=0.261N   |
|INCIDENTAL TUMOR       |  P=0.304N     P=0.113      P=0.187      P=0.482N   |  P=0.468N     P=0.017N*    P=0.331N     P=0.245N   |
|LOGISTIC REGRESSION    |  P=0.418N     P=0.114      P=0.218      P=0.585    |  P=0.394N     P=0.010N*    P=0.273N     P=0.214N   |
|COCHRAN-ARMITAGE       |  P=0.369N                                          |  P=0.481N                                          |
|FISHER EXACT           |               P=0.102      P=0.181      P=0.605N   |               P=0.114N     P=0.339N     P=0.339N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/60 (65%)  27/60 (45%)  35/60 (58%)  25/60 (42%) | 27/60 (45%)  27/60 (45%)  16/60 (27%)  22/60 (37%) |
|ADJUSTED (b)           |  77.9%        60.2%        71.3%        56.4%      |  59.0%        57.9%        34.3%        50.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           | 11/22 (50%)  14/31 (45%)  15/29 (52%)  14/33 (42%) | 13/31 (42%)  17/36 (47%)   9/39 (23%)  11/32 (34%) |
|FIRST INCIDENCE (DAYS) |   305          520          453 (I)      564       |   359          428          458 (I)      458 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.017N*    P=0.015N*    P=0.128N     P=0.005N** |  P=0.123N     P=0.295N     P=0.014N*    P=0.194N   |
|INCIDENTAL TUMOR       |  P=0.081N     P=0.042N*    P=0.573N     P=0.044N*  |  P=0.086N     P=0.552      P=0.112N     P=0.212N   |
|LOGISTIC REGRESSION    |  P=0.043N*    P=0.014N*    P=0.284N     P=0.010N** |  P=0.086N     P=0.485N     P=0.026N*    P=0.190N   |
|COCHRAN-ARMITAGE       |  P=0.032N*                                         |  P=0.112N                                          |
|FISHER EXACT           |               P=0.022N*    P=0.287N     P=0.009N** |               P=0.573N     P=0.028N*    P=0.229N   |
|=================================================================================================================================|
 
         DATE: 09/16/94                     EXPERIMENT: 05127 TEST: 01                                                 PAGE  22
                        STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BARIUM CHLORIDE DIHYDRATE
 
                                                 MALE TERMINAL SACRIFICE AT 105 WEEKS
                                                 FEMALE TERMINAL SACRIFICE AT 106 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 PPM        500 PPM      1250 PPM     2500 PPM  |   0 PPM        500 PPM      1250 PPM     2500 PPM  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 56/60 (93%)  57/60 (95%)  59/60 (98%)  57/60 (95%) | 51/60 (85%)  44/60 (73%)  48/60 (80%)  50/60 (83%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  96.2%        89.8%        88.8%        94.3%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   7/10 (70%)   9/10 (90%)   9/10 (90%) |  3/10 (30%)   0/10 (0%)    4/10 (40%)   5/10 (50%) |
|TERMINAL (d)           | 22/22 (100%) 31/31 (100%) 29/29 (100%) 33/33 (100%)| 29/31 (94%)  31/36 (86%)  33/39 (85%)  29/32 (91%) |
|FIRST INCIDENCE (DAYS) |   305          452 (I)      452 (I)      452 (I)   |   359          428          310          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.110N     P=0.136N     P=0.235N     P=0.079N   |  P=0.480      P=0.018N*    P=0.063N     P=0.354N   |
|INCIDENTAL TUMOR       |  P=0.380      P=0.500      P=0.157      P=0.533    |  P=0.380      P=0.042N*    P=0.376N     P=0.509N   |
|LOGISTIC REGRESSION    |  P=0.261      P=0.647      P=0.253      P=0.435    |  P=0.493      P=0.016N*    P=0.274N     P=0.343N   |
|COCHRAN-ARMITAGE       |  P=0.395                                           |  P=0.410                                           |
|FISHER EXACT           |               P=0.500      P=0.182      P=0.500    |               P=0.088N     P=0.316N     P=0.500N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   452
          Female interim sacrifices(days): 456
 (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).