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TR 392 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:12:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                       90-DAY LOW DOSE GROUPS                                                       
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    VEHICLE 3 SSAC                                                                
                                       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 004    VEHICLE 3 SSAC                                                                
                                       INCLUDE 010    0.0100% 3 SSAC                                                                
                                       INCLUDE 012    0.0100% 3 SSAC                                                                
                                       INCLUDE 014    0.00500% 3 SSAC                                                               
                                       INCLUDE 016    0.00500% 3 SSAC                                                               
                                       INCLUDE 026    0.00700% 3 SSAC                                                               
                                       INCLUDE 028    0.00700% 3 SSAC                                                               
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94      
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:12:51      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B      
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:12:51       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF CHLORAMINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/70 (7%)       0/3 (0%)        0/2 (0%)       |     0/70 (0%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     13.9%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     4/34 (12%)      0/0             0/0            |     0/33 (0%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      681             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.568N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.806N        P=0.865N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/70 (4%)       0/3 (0%)        0/2 (0%)       |     1/70 (1%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      8.8%            0.0%            0.0%          |      3.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     3/34 (9%)       0/0             0/0            |     1/33 (3%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      733 (T)         ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.701N                                       |     P=0.746N                                       |
|FISHER EXACT           |                     P=0.880N        P=0.918N       |                     P=0.921N        P=0.946N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    33/70 (47%)      0/3 (0%)        0/2 (0%)       |    20/70 (29%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     72.7%            0.0%            0.0%          |     54.6%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     3/10 (30%)      0/0             0/0            |     1/10 (10%)      0/0             0/0            |
|TERMINAL (d)           |    22/34 (65%)      0/0             0/0            |    17/33 (52%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      457 (I)         ---             ---           |      457 (I)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.869N        P=0.968N        P=0.989N       |     P=0.984N          (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.052N                                       |     P=0.059N                                       |
|FISHER EXACT           |                     P=0.159N        P=0.290N       |                     P=0.149N        P=0.275N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    14/70 (20%)      0/3 (0%)        0/2 (0%)       |     6/70 (9%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     29.4%            0.0%            0.0%          |     17.2%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     2/10 (20%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     4/34 (12%)      0/0             0/0            |     5/33 (15%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      659             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.536N        P=0.712N        P=0.800N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.277N                                       |     P=0.318N                                       |
|FISHER EXACT           |                     P=0.523N        P=0.647N       |                     P=0.600N        P=0.708N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/70 (21%)      0/3 (0%)        0/2 (0%)       |     6/70 (9%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     31.2%            0.0%            0.0%          |     17.2%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     2/10 (20%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     4/34 (12%)      0/0             0/0            |     5/33 (15%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      659             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.535N        P=0.711N        P=0.799N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.257N                                       |     P=0.318N                                       |
|FISHER EXACT           |                     P=0.496N        P=0.624N       |                     P=0.600N        P=0.708N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    40/70 (57%)      0/3 (0%)        0/2 (0%)       |    21/70 (30%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     78.0%            0.0%            0.0%          |     55.8%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     5/10 (50%)      0/0             0/0            |     1/10 (10%)      0/0             0/0            |
|TERMINAL (d)           |    23/34 (68%)      0/0             0/0            |    17/33 (52%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      457 (I)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.595N        P=0.769N        P=0.850N       |     P=0.963N        P=1.000N          (e)          |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.051N                                       |
|FISHER EXACT           |                     P=0.088N        P=0.194N       |                     P=0.133N        P=0.254N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    40/70 (57%)      0/3 (0%)        0/2 (0%)       |    21/70 (30%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     78.0%            0.0%            0.0%          |     55.8%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     5/10 (50%)      0/0             0/0            |     1/10 (10%)      0/0             0/0            |
|TERMINAL (d)           |    23/34 (68%)      0/0             0/0            |    17/33 (52%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      457 (I)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.595N        P=0.769N        P=0.850N       |     P=0.963N        P=1.000N          (e)          |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.051N                                       |
|FISHER EXACT           |                     P=0.088N        P=0.194N       |                     P=0.133N        P=0.254N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/70 (26%)      0/3 (0%)        0/2 (0%)       |     4/70 (6%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     39.4%            0.0%            0.0%          |     10.6%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     3/10 (30%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     9/34 (26%)      0/0             0/0            |     3/33 (9%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      455 (I)         ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.553N        P=0.729N        P=0.815N       |     P=0.851N        P=0.981N        P=0.992N       |
|COCHRAN-ARMITAGE       |     P=0.205N                                       |     P=0.418N                                       |
|FISHER EXACT           |                     P=0.422N        P=0.560N       |                     P=0.715N        P=0.797N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/70 (13%)      0/3 (0%)        0/2 (0%)       |     1/70 (1%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     22.1%            0.0%            0.0%          |      3.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/10 (10%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     5/34 (15%)      0/0             0/0            |     1/33 (3%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      457 (I)         ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.894N        P=0.976N        P=0.992N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.404N                                       |     P=0.746N                                       |
|FISHER EXACT           |                     P=0.670N        P=0.764N       |                     P=0.921N        P=0.946N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/70 (36%)      0/3 (0%)        0/2 (0%)       |     5/70 (7%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     51.3%            0.0%            0.0%          |     13.6%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     4/10 (40%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |    12/34 (35%)      0/0             0/0            |     4/33 (12%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      455 (I)         ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.479N        P=0.659N        P=0.755N       |     P=0.884N        P=0.990N        P=0.997N       |
|COCHRAN-ARMITAGE       |     P=0.116N                                       |     P=0.363N                                       |
|FISHER EXACT           |                     P=0.278N        P=0.423N       |                     P=0.655N        P=0.751N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/66 (3%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |                                                    |      6.9%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|                                                    |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |                                                    |     2/29 (7%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |                                                    |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |                                                    |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |                                                    |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.574N                                       |
|FISHER EXACT           |                                                    |                     P=0.839N        P=0.888N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/68 (0%)       0/3 (0%)        0/2 (0%)       |     5/68 (7%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     14.6%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     0/32 (0%)       0/0             0/0            |     4/33 (12%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      698             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.357N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.647N        P=0.745N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/70 (4%)       0/3 (0%)        0/2 (0%)       |     1/69 (1%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      8.8%            0.0%            0.0%          |      3.1%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     3/34 (9%)       0/0             0/0            |     1/32 (3%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      733 (T)         ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.701N                                       |     P=0.743N                                       |
|FISHER EXACT           |                     P=0.880N        P=0.918N       |                     P=0.920N        P=0.945N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/70 (3%)       0/3 (0%)        0/2 (0%)       |     0/70 (0%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      4.2%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     1/10 (10%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     0/34 (0%)       0/0             0/0            |     0/33 (0%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.866N        P=0.959N        P=0.982N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.796N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.919N        P=0.945N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/70 (1%)       0/3 (0%)        0/2 (0%)       |     3/70 (4%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      2.5%            0.0%            0.0%          |      7.7%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     1/10 (10%)      0/0             0/0            |
|TERMINAL (d)           |     0/34 (0%)       0/0             0/0            |     2/33 (6%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      691             ---             ---           |      456 (I)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.817N        P=0.968N        P=0.985N       |
|COCHRAN-ARMITAGE       |     P=0.924N                                       |     P=0.488N                                       |
|FISHER EXACT           |                     P=0.959N        P=0.972N       |                     P=0.779N        P=0.844N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/70 (4%)       0/3 (0%)        0/2 (0%)       |     3/70 (4%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      8.4%            0.0%            0.0%          |      9.1%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     2/34 (6%)       0/0             0/0            |     3/33 (9%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      730             ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.701N                                       |     P=0.488N                                       |
|FISHER EXACT           |                     P=0.880N        P=0.918N       |                     P=0.779N        P=0.844N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/70 (4%)       0/3 (0%)        0/2 (0%)       |     3/70 (4%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      8.8%            0.0%            0.0%          |      9.1%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     3/34 (9%)       0/0             0/0            |     3/33 (9%)       0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      733 (T)         ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.701N                                       |     P=0.488N                                       |
|FISHER EXACT           |                     P=0.880N        P=0.918N       |                     P=0.779N        P=0.844N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/70 (9%)       0/3 (0%)        0/2 (0%)       |     5/70 (7%)       0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     17.0%            0.0%            0.0%          |     15.2%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     5/34 (15%)      0/0             0/0            |     5/33 (15%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      730             ---             ---           |      733 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.518N                                       |     P=0.363N                                       |
|FISHER EXACT           |                     P=0.770N        P=0.839N       |                     P=0.655N        P=0.751N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/3 (0%)        0/2 (0%)       |     9/70 (13%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     22.9%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     0/34 (0%)       0/0             0/0            |     5/33 (15%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.828N        P=0.975N        P=0.990N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.221N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.456N        P=0.588N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/70 (0%)       0/3 (0%)        0/2 (0%)       |     9/70 (13%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     22.9%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     0/10 (0%)       0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |     0/34 (0%)       0/0             0/0            |     5/33 (15%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.828N        P=0.975N        P=0.990N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.221N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.456N        P=0.588N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    45/70 (64%)      0/3 (0%)        0/2 (0%)       |    29/70 (41%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     86.2%            0.0%            0.0%          |     71.3%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     6/10 (60%)      0/0             0/0            |     3/10 (30%)      0/0             0/0            |
|TERMINAL (d)           |    27/34 (79%)      0/0             0/0            |    22/33 (67%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      455 (I)         ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.596N        P=0.770N        P=0.850N       |     P=0.647N        P=0.868N        P=0.922N       |
|COCHRAN-ARMITAGE       |     P=0.008N**                                     |     P=0.016N*                                      |
|FISHER EXACT           |                     P=0.053N        P=0.137N       |                     P=0.049N*       P=0.129N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    25/70 (36%)      0/3 (0%)        0/2 (0%)       |    23/70 (33%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     50.7%            0.0%            0.0%          |     54.1%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     3/10 (30%)      0/0             0/0            |     0/10 (0%)       0/0             0/0            |
|TERMINAL (d)           |    11/34 (32%)      0/0             0/0            |    14/33 (42%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      456 (I)         ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.513N        P=0.692N        P=0.784N       |     P=0.871N        P=0.990N        P=0.997N       |
|COCHRAN-ARMITAGE       |     P=0.116N                                       |     P=0.039N*                                      |
|FISHER EXACT           |                     P=0.278N        P=0.423N       |                     P=0.105N        P=0.217N       |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         0.00700%        0.0100%       |      VEHICLE         0.00500%        0.0100%       |
|                       |      3 SSAC          3 SSAC          3 SSAC        |      3 SSAC          3 SSAC          3 SSAC        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/70 (70%)      0/3 (0%)        0/2 (0%)       |    38/70 (54%)      0/6 (0%)        0/4 (0%)       |
|ADJUSTED (b)           |     88.9%            0.0%            0.0%          |     84.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/1 (0%)        0/0             0/1 (0%)       |
|INTERIM SACRIFICE 2 (c)|     7/10 (70%)      0/0             0/0            |     3/10 (30%)      0/0             0/0            |
|TERMINAL (d)           |    28/34 (82%)      0/0             0/0            |    26/33 (79%)      0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      455 (I)         ---             ---           |      452             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.520N        P=0.699N        P=0.790N       |     P=0.761N        P=0.949N        P=0.978N       |
|COCHRAN-ARMITAGE       |     P=0.003N**                                     |     P=0.003N**                                     |
|FISHER EXACT           |                     P=0.033N*       P=0.099N       |                     P=0.013N*       P=0.051N       |
|=================================================================================================================================|
 
 (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):   102  455
          Female interim sacrifices(days): 102  455
 (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).
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:14:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                      90-DAY HIGH DOSE GROUPS                                                       
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    VEHICLE 3 SSAC                                                                
                                       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 004    VEHICLE 3 SSAC                                                                
                                       INCLUDE 006    0.0200% 3 SSAC                                                                
                                       INCLUDE 008    0.0200% 3 SSAC                                                                
                                       INCLUDE 018    0.0275% 3 SSAC                                                                
                                       INCLUDE 020    0.0275% 3 SSAC                                                                
                                       INCLUDE 022    0.0140% 3 SSAC                                                                
                                       INCLUDE 024    0.0140% 3 SSAC                                                                
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94      
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:14:19      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B      
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:14:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF CHLORAMINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatoblastoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/70 (7%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  0/70 (0%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  13.9%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  4/34 (12%)   0/0          0/0          0/0        |  0/33 (0%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   681          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.181N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.930N     P=0.503N     P=0.503N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  1/70 (1%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         0.0%         0.0%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  3/34 (9%)    0/0          0/0          0/0        |  1/33 (3%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.565N                                          |
|FISHER EXACT           |               P=0.958N     P=0.666N     P=0.666N   |               P=0.986N     P=0.875N     P=0.875N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/70 (47%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 20/70 (29%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  72.7%         0.0%         0.0%         0.0%      |  54.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  3/10 (30%)   0/0          0/0          0/0        |  1/10 (10%)   0/0          0/0          0/0        |
|TERMINAL (d)           | 22/34 (65%)   0/0          0/0          0/0        | 17/33 (52%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   457 (I)      ---          ---          ---       |   457 (I)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.509N     P=1.000N     P=0.817N     P=0.818N   |  P=0.905N       (e)        P=0.999N     P=0.999N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.006N**                                        |
|FISHER EXACT           |               P=0.535N     P=0.003N**   P=0.003N** |               P=0.718N     P=0.046N*    P=0.046N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/70 (20%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |  6/70 (9%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  29.4%         0.0%         0.0%         0.0%      |  17.2%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  2/10 (20%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  4/34 (12%)   0/0          0/0          0/0        |  5/33 (15%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   659          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.176N     P=0.921N     P=0.428N     P=0.428N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.024N*                                         |  P=0.144N                                          |
|FISHER EXACT           |               P=0.803N     P=0.128N     P=0.128N   |               P=0.915N     P=0.436N     P=0.436N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/70 (21%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |  6/70 (9%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  31.2%         0.0%         0.0%         0.0%      |  17.2%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  2/10 (20%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  4/34 (12%)   0/0          0/0          0/0        |  5/33 (15%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   659          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.175N     P=0.921N     P=0.426N     P=0.427N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.019N*                                         |  P=0.144N                                          |
|FISHER EXACT           |               P=0.789N     P=0.109N     P=0.109N   |               P=0.915N     P=0.436N     P=0.436N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/70 (57%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 21/70 (30%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  78.0%         0.0%         0.0%         0.0%      |  55.8%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  5/10 (50%)   0/0          0/0          0/0        |  1/10 (10%)   0/0          0/0          0/0        |
|TERMINAL (d)           | 23/34 (68%)   0/0          0/0          0/0        | 17/33 (52%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   457 (I)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.222N     P=0.951N     P=0.490N     P=0.490N   |  P=0.857N       (e)        P=0.997N     P=0.997N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.437N     P<0.001N**   P<0.001N** |               P=0.704N     P=0.038N*    P=0.038N*  |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/70 (57%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 21/70 (30%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  78.0%         0.0%         0.0%         0.0%      |  55.8%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  5/10 (50%)   0/0          0/0          0/0        |  1/10 (10%)   0/0          0/0          0/0        |
|TERMINAL (d)           | 23/34 (68%)   0/0          0/0          0/0        | 17/33 (52%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   457 (I)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.222N     P=0.951N     P=0.490N     P=0.490N   |  P=0.857N       (e)        P=0.997N     P=0.997N   |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.437N     P<0.001N**   P<0.001N** |               P=0.704N     P=0.038N*    P=0.038N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/70 (26%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |  4/70 (6%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  39.4%         0.0%         0.0%         0.0%      |  10.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  3/10 (30%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  9/34 (26%)   0/0          0/0          0/0        |  3/33 (9%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   455 (I)      ---          ---          ---       |   452          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.190N     P=0.930N     P=0.447N     P=0.448N   |  P=0.732N       (e)        P=0.958N     P=0.958N   |
|COCHRAN-ARMITAGE       |  P=0.009N**                                        |  P=0.230N                                          |
|FISHER EXACT           |               P=0.746N     P=0.065N     P=0.065N   |               P=0.944N     P=0.580N     P=0.580N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/70 (13%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |  1/70 (1%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  22.1%         0.0%         0.0%         0.0%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  5/34 (15%)   0/0          0/0          0/0        |  1/33 (3%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   457 (I)      ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.578N     P=1.000N     P=0.868N     P=0.869N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.074N                                          |  P=0.565N                                          |
|FISHER EXACT           |               P=0.873N     P=0.280N     P=0.280N   |               P=0.986N     P=0.875N     P=0.875N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/70 (36%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |  5/70 (7%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  51.3%         0.0%         0.0%         0.0%      |  13.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  4/10 (40%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           | 12/34 (35%)   0/0          0/0          0/0        |  4/33 (12%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   455 (I)      ---          ---          ---       |   452          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.132N     P=0.894N     P=0.357N     P=0.358N   |  P=0.769N       (e)        P=0.974N     P=0.974N   |
|COCHRAN-ARMITAGE       |  P=0.001N**                                        |  P=0.181N                                          |
|FISHER EXACT           |               P=0.648N     P=0.018N*    P=0.018N*  |               P=0.930N     P=0.503N     P=0.503N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/66 (3%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |                                                    |   6.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|                                                    |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |                                                    |  2/29 (7%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |                                                    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.769N       (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.383N                                          |
|FISHER EXACT           |                                                    |               P=0.970N     P=0.753N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/68 (0%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  5/68 (7%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  14.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  0/32 (0%)    0/0          0/0          0/0        |  4/33 (12%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   698          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.175N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.928N     P=0.494N     P=0.494N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  1/69 (1%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         0.0%         0.0%      |   3.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  3/34 (9%)    0/0          0/0          0/0        |  1/32 (3%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.562N                                          |
|FISHER EXACT           |               P=0.958N     P=0.666N     P=0.666N   |               P=0.986N     P=0.873N     P=0.873N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/70 (3%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  0/70 (0%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   4.2%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  1/10 (10%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  0/34 (0%)    0/0          0/0          0/0        |  0/33 (0%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.565N     P=0.998N     P=0.854N     P=0.854N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.395N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.972N     P=0.764N     P=0.764N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/70 (1%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%         0.0%      |   7.7%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  1/10 (10%)   0/0          0/0          0/0        |
|TERMINAL (d)           |  0/34 (0%)    0/0          0/0          0/0        |  2/33 (6%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   691          ---          ---          ---       |   456 (I)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.999N       (e)          (e)          (e)      |  P=0.694N       (e)        P=0.939N     P=0.939N   |
|COCHRAN-ARMITAGE       |  P=0.565N                                          |  P=0.296N                                          |
|FISHER EXACT           |               P=0.986N     P=0.875N     P=0.875N   |               P=0.958N     P=0.666N     P=0.666N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   8.4%         0.0%         0.0%         0.0%      |   9.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  2/34 (6%)    0/0          0/0          0/0        |  3/33 (9%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   730          ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.296N                                          |
|FISHER EXACT           |               P=0.958N     P=0.666N     P=0.666N   |               P=0.958N     P=0.666N     P=0.666N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  3/70 (4%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         0.0%         0.0%      |   9.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  3/34 (9%)    0/0          0/0          0/0        |  3/33 (9%)    0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.296N                                          |
|FISHER EXACT           |               P=0.958N     P=0.666N     P=0.666N   |               P=0.958N     P=0.666N     P=0.666N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/70 (9%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  5/70 (7%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  17.0%         0.0%         0.0%         0.0%      |  15.2%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  5/34 (15%)   0/0          0/0          0/0        |  5/33 (15%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   730          ---          ---          ---       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.144N                                          |  P=0.181N                                          |
|FISHER EXACT           |               P=0.915N     P=0.436N     P=0.436N   |               P=0.930N     P=0.503N     P=0.503N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  9/70 (13%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  22.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  0/34 (0%)    0/0          0/0          0/0        |  5/33 (15%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   452          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.690N       (e)        P=0.943N     P=0.943N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.074N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.873N     P=0.280N     P=0.280N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/70 (0%)    0/1 (0%)     0/10 (0%)    0/10 (0%)  |  9/70 (13%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  22.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  0/10 (0%)    0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           |  0/34 (0%)    0/0          0/0          0/0        |  5/33 (15%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   452          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.690N       (e)        P=0.943N     P=0.943N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.074N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.873N     P=0.280N     P=0.280N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/70 (64%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 29/70 (41%)   0/1 (0%)     0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           |  86.2%         0.0%         0.0%         0.0%      |  71.3%         0.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  6/10 (60%)   0/0          0/0          0/0        |  3/10 (30%)   0/0          0/0          0/0        |
|TERMINAL (d)           | 27/34 (79%)   0/0          0/0          0/0        | 22/33 (67%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   455 (I)      ---          ---          ---       |   452          ---          ---           97 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.314        (e)          (e)        P=0.450    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.314        (e)          (e)        P=0.450    |
|LOGISTIC REGRESSION    |  P=0.223N     P=0.951N     P=0.491N     P=0.492N   |  P=0.434      P=0.999N     P=0.782N     P=0.498    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.366N     P<0.001N**   P<0.001N** |               P=0.592N     P=0.008N**   P=0.052N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/70 (36%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 23/70 (33%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  50.7%         0.0%         0.0%         0.0%      |  54.1%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  3/10 (30%)   0/0          0/0          0/0        |  0/10 (0%)    0/0          0/0          0/0        |
|TERMINAL (d)           | 11/34 (32%)   0/0          0/0          0/0        | 14/33 (42%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          ---       |   452          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.157N     P=0.912N     P=0.397N     P=0.397N   |  P=0.722N       (e)        P=0.965N     P=0.965N   |
|COCHRAN-ARMITAGE       |  P=0.001N**                                        |  P=0.002N**                                        |
|FISHER EXACT           |               P=0.648N     P=0.018N*    P=0.018N*  |               P=0.676N     P=0.026N*    P=0.026N*  |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |   3 SSAC       3 SSAC       3 SSAC       3 SSAC    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/70 (70%)   0/1 (0%)     0/10 (0%)    0/10 (0%)  | 38/70 (54%)   0/1 (0%)     0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           |  88.9%         0.0%         0.0%         0.0%      |  84.0%         0.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/1 (0%)     0/0          0/3 (0%)     0/2 (0%)   |  0/1 (0%)     0/1 (0%)     0/1 (0%)     0/3 (0%)   |
|INTERIM SACRIFICE 2 (c)|  7/10 (70%)   0/0          0/0          0/0        |  3/10 (30%)   0/0          0/0          0/0        |
|TERMINAL (d)           | 28/34 (82%)   0/0          0/0          0/0        | 26/33 (79%)   0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   455 (I)      ---          ---          ---       |   452          ---          ---           97 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.314        (e)          (e)        P=0.450    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.314        (e)          (e)        P=0.450    |
|LOGISTIC REGRESSION    |  P=0.162N     P=0.916N     P=0.402N     P=0.403N   |  P=0.304        (e)        P=0.889N     P=0.390    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P<0.001N**                                        |
|FISHER EXACT           |               P=0.310N     P<0.001N**   P<0.001N** |               P=0.465N     P<0.001N**   P=0.009N** |
|=================================================================================================================================|
 
 (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):   102  455
          Female interim sacrifices(days): 102  455
 (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).
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:20:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     CORE STUDY LOW DOSE GROUPS                                                     
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 009    0.0100%                                                                       
                                       INCLUDE 011    0.0100%                                                                       
                                       INCLUDE 013    0.00500%                                                                      
                                       INCLUDE 015    0.00500%                                                                      
                                       INCLUDE 025    0.00700%                                                                      
                                       INCLUDE 027    0.00700%                                                                      
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94      
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:20:16      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B      
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:20:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF CHLORAMINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Hemangioma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Islets, Pancreatic            Carcinoma or Adenoma
                             Ovary                         Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
 
              ====================================================================================================
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    4/60 (7%)    4/60 (7%)    4/60 (7%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |  13.9%        13.9%        12.4%        11.2%      |   0.0%         0.0%         0.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   2/23 (9%)    2/28 (7%)    3/34 (9%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   681          652          682          727       |   ---          ---          ---          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.433N     P=0.598      P=0.599N     P=0.497N   |  P=0.299        (e)          (e)        P=0.512    |
|INCIDENTAL TUMOR       |  P=0.414N     P=0.523N     P=0.526N     P=0.487N   |  P=0.299        (e)          (e)        P=0.512    |
|LOGISTIC REGRESSION    |  P=0.412N     P=0.532N     P=0.543N     P=0.483N   |  P=0.299        (e)          (e)        P=0.512    |
|COCHRAN-ARMITAGE       |  P=0.418N                                          |  P=0.291                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    3/60 (5%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.8%         3.2%         8.9%         2.9%      |   3.0%         3.1%         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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/23 (0%)    1/28 (4%)    1/34 (3%)  |  1/33 (3%)    1/32 (3%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      727          668          733 (T)   |   733 (T)      733 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.309N     P=0.435N     P=0.583      P=0.304N   |  P=0.244N     P=0.755      P=0.512N     P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.347N     P=0.643      P=0.304N   |  P=0.244N     P=0.755      P=0.512N     P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.365N     P=0.632      P=0.304N   |  P=0.244N     P=0.755      P=0.512N     P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.293N                                          |  P=0.247N                                          |
|FISHER EXACT           |               P=0.309N     P=0.660N     P=0.309N   |               P=0.752N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    4/60 (7%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.8%         3.2%        10.8%         2.9%      |   3.0%         3.1%         3.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/23 (0%)    1/28 (4%)    1/34 (3%)  |  1/33 (3%)    1/32 (3%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      727          522          733 (T)   |   733 (T)      733 (T)      730          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.367N     P=0.435N     P=0.423      P=0.304N   |  P=0.618N     P=0.755      P=0.750      P=0.749N   |
|INCIDENTAL TUMOR       |  P=0.376N     P=0.347N     P=0.532      P=0.304N   |  P=0.615N     P=0.755      P=0.753      P=0.749N   |
|LOGISTIC REGRESSION    |  P=0.351N     P=0.365N     P=0.486      P=0.304N   |  P=0.600N     P=0.755      P=0.763      P=0.749N   |
|COCHRAN-ARMITAGE       |  P=0.354N                                          |  P=0.635                                           |
|FISHER EXACT           |               P=0.309N     P=0.500      P=0.309N   |               P=0.752N     P=0.752N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    1/60 (2%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         8.4%         3.4%         7.2%      |   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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/34 (3%)    0/23 (0%)    0/28 (0%)    1/34 (3%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      565          730          581       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.304      P=0.251      P=0.711      P=0.318    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.299      P=0.410      P=0.754N     P=0.316    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.296      P=0.301      P=0.733      P=0.309    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.293                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309      P=0.752N     P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    1/60 (2%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         4.9%         3.4%         7.2%      |   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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    0/28 (0%)    1/34 (3%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          565          730          581       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.107      P=0.234      P=0.451      P=0.131    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.088      P=0.337      P=0.552      P=0.130    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.096      P=0.240      P=0.477      P=0.121    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.096                                           |    (e)                                             |
|FISHER EXACT           |               P=0.248      P=0.500      P=0.122    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/59 (2%)    2/58 (3%)  |
|ADJUSTED (b)           |   0.0%         4.3%         3.0%         2.2%      |   0.0%         0.0%         3.2%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/23 (4%)    0/28 (0%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    1/31 (3%)    0/33 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      723          677       |   ---          ---          733 (T)      669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.325      P=0.422      P=0.472      P=0.519    |  P=0.111        (e)        P=0.488      P=0.264    |
|INCIDENTAL TUMOR       |  P=0.314      P=0.422      P=0.552      P=0.519    |  P=0.113        (e)        P=0.488      P=0.280    |
|LOGISTIC REGRESSION    |  P=0.320      P=0.422      P=0.485      P=0.501    |  P=0.101        (e)        P=0.488      P=0.236    |
|COCHRAN-ARMITAGE       |  P=0.316                                           |  P=0.097                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |                 (e)        P=0.496      P=0.239    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/59 (2%)    3/58 (5%)  |
|ADJUSTED (b)           |   0.0%         4.3%         6.1%         2.2%      |   0.0%         0.0%         3.2%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/23 (4%)    0/28 (0%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    1/31 (3%)    1/33 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      723          677       |   ---          ---          733 (T)      669       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.275      P=0.422      P=0.206      P=0.519    |  P=0.047 *      (e)        P=0.488      P=0.137    |
|INCIDENTAL TUMOR       |  P=0.260      P=0.422      P=0.295      P=0.519    |  P=0.048 *      (e)        P=0.488      P=0.144    |
|LOGISTIC REGRESSION    |  P=0.271      P=0.422      P=0.219      P=0.501    |  P=0.043 *      (e)        P=0.488      P=0.123    |
|COCHRAN-ARMITAGE       |  P=0.267                                           |  P=0.039 *                                         |
|FISHER EXACT           |               P=0.500      P=0.248      P=0.500    |                 (e)        P=0.496      P=0.116    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    2/60 (3%)    4/60 (7%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         3.7%         5.7%         9.8%      |   3.0%         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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  1/34 (3%)    0/23 (0%)    0/28 (0%)    1/34 (3%)  |  1/33 (3%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      732          638          618       |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.120      P=0.690      P=0.447      P=0.191    |  P=0.204N     P=0.506N     P=0.512N     P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.104      P=0.736N     P=0.546      P=0.194    |  P=0.204N     P=0.506N     P=0.512N     P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.112      P=0.716      P=0.488      P=0.185    |  P=0.204N     P=0.506N     P=0.512N     P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.108                                           |  P=0.204N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500      P=0.182    |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.5%         0.0%         6.3%         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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    1/28 (4%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   691          ---          698          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.497N     P=0.510N     P=0.459      P=0.490N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.492N     P=0.362N     P=0.539      P=0.481N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.498N     P=0.504N     P=0.485      P=0.498N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/60 (55%)  34/60 (57%)  29/60 (48%)  23/60 (38%) | 20/60 (33%)  14/60 (23%)  19/60 (32%)  22/60 (37%) |
|ADJUSTED (b)           |  72.7%        89.2%        75.7%        57.0%      |  54.6%        40.9%        53.2%        51.9%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 22/34 (65%)  19/23 (83%)  19/28 (68%)  17/34 (50%) | 17/33 (52%)  12/32 (38%)  15/31 (48%)  15/35 (43%) |
|FIRST INCIDENCE (DAYS) |   457 (I)      559          562          638       |   457 (I)      717          552          628       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.067N     P=0.062      P=0.509      P=0.055N   |  P=0.450      P=0.159N     P=0.581      P=0.531    |
|INCIDENTAL TUMOR       |  P=0.025N*    P=0.400      P=0.380N     P=0.034N*  |  P=0.437      P=0.131N     P=0.487N     P=0.471    |
|LOGISTIC REGRESSION    |  P=0.020N*    P=0.441      P=0.343N     P=0.032N*  |  P=0.497      P=0.115N     P=0.488N     P=0.559    |
|COCHRAN-ARMITAGE       |  P=0.041N*                                         |  P=0.380                                           |
|FISHER EXACT           |               P=0.500      P=0.292N     P=0.050N*  |               P=0.156N     P=0.500N     P=0.424    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/60 (23%)  16/60 (27%)  13/60 (22%)  16/60 (27%) |  6/60 (10%)  11/60 (18%)   7/60 (12%)   6/60 (10%) |
|ADJUSTED (b)           |  29.4%        40.8%        31.8%        34.9%      |  17.2%        26.6%        19.5%        15.1%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   4/23 (17%)   4/28 (14%)   6/34 (18%) |  5/33 (15%)   4/32 (13%)   4/31 (13%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      490          455 (I)   |   659          585          589          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.446      P=0.269      P=0.548      P=0.446    |  P=0.478N     P=0.160      P=0.468      P=0.571N   |
|INCIDENTAL TUMOR       |  P=0.445      P=0.478N     P=0.316N     P=0.369    |  P=0.514N     P=0.235      P=0.514      P=0.582N   |
|LOGISTIC REGRESSION    |  P=0.427      P=0.490      P=0.404N     P=0.376    |  P=0.493N     P=0.159      P=0.505      P=0.581N   |
|COCHRAN-ARMITAGE       |  P=0.435                                           |  P=0.532N                                          |
|FISHER EXACT           |               P=0.417      P=0.500N     P=0.417    |               P=0.148      P=0.500      P=0.619N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/60 (25%)  16/60 (27%)  14/60 (23%)  16/60 (27%) |  6/60 (10%)  11/60 (18%)   7/60 (12%)   6/60 (10%) |
|ADJUSTED (b)           |  31.2%        40.8%        33.7%        34.9%      |  17.2%        26.6%        19.5%        15.1%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   4/23 (17%)   4/28 (14%)   6/34 (18%) |  5/33 (15%)   4/32 (13%)   4/31 (13%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      490          455 (I)   |   659          585          589          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.504      P=0.336      P=0.540      P=0.522    |  P=0.478N     P=0.160      P=0.468      P=0.571N   |
|INCIDENTAL TUMOR       |  P=0.519      P=0.363N     P=0.296N     P=0.461    |  P=0.514N     P=0.235      P=0.514      P=0.582N   |
|LOGISTIC REGRESSION    |  P=0.496      P=0.583      P=0.396N     P=0.462    |  P=0.493N     P=0.159      P=0.505      P=0.581N   |
|COCHRAN-ARMITAGE       |  P=0.500                                           |  P=0.532N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500    |               P=0.148      P=0.500      P=0.619N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/60 (67%)  40/60 (67%)  38/60 (63%)  34/60 (57%) | 21/60 (35%)  21/60 (35%)  22/60 (37%)  24/60 (40%) |
|ADJUSTED (b)           |  78.0%        90.7%        84.1%        71.8%      |  55.8%        52.8%        58.4%        55.0%      |
|INTERIM SACRIFICE 1 (c)|  5/10 (50%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 23/34 (68%)  19/23 (83%)  21/28 (75%)  21/34 (62%) | 17/33 (52%)  14/32 (44%)  16/31 (52%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      490          455 (I)   |   457 (I)      585          552          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234N     P=0.102      P=0.356      P=0.207N   |  P=0.409      P=0.554      P=0.420      P=0.463    |
|INCIDENTAL TUMOR       |  P=0.126N     P=0.539N     P=0.401N     P=0.174N   |  P=0.361      P=0.464N     P=0.543      P=0.392    |
|LOGISTIC REGRESSION    |  P=0.121N     P=0.546      P=0.472N     P=0.149N   |  P=0.417      P=0.531N     P=0.513      P=0.461    |
|COCHRAN-ARMITAGE       |  P=0.156N                                          |  P=0.323                                           |
|FISHER EXACT           |               P=0.577N     P=0.424N     P=0.174N   |               P=0.576N     P=0.500      P=0.353    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/60 (67%)  40/60 (67%)  38/60 (63%)  34/60 (57%) | 21/60 (35%)  21/60 (35%)  22/60 (37%)  24/60 (40%) |
|ADJUSTED (b)           |  78.0%        90.7%        84.1%        71.8%      |  55.8%        52.8%        58.4%        55.0%      |
|INTERIM SACRIFICE 1 (c)|  5/10 (50%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 23/34 (68%)  19/23 (83%)  21/28 (75%)  21/34 (62%) | 17/33 (52%)  14/32 (44%)  16/31 (52%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      490          455 (I)   |   457 (I)      585          552          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234N     P=0.102      P=0.356      P=0.207N   |  P=0.409      P=0.554      P=0.420      P=0.463    |
|INCIDENTAL TUMOR       |  P=0.126N     P=0.539N     P=0.401N     P=0.174N   |  P=0.361      P=0.464N     P=0.543      P=0.392    |
|LOGISTIC REGRESSION    |  P=0.121N     P=0.546      P=0.472N     P=0.149N   |  P=0.417      P=0.531N     P=0.513      P=0.461    |
|COCHRAN-ARMITAGE       |  P=0.156N                                          |  P=0.323                                           |
|FISHER EXACT           |               P=0.577N     P=0.424N     P=0.174N   |               P=0.576N     P=0.500      P=0.353    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/60 (30%)  12/60 (20%)  10/60 (17%)  11/60 (18%) |  4/60 (7%)    3/60 (5%)    5/60 (8%)    2/60 (3%)  |
|ADJUSTED (b)           |  39.4%        38.5%        29.4%        31.1%      |  10.6%         9.4%        15.3%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  9/34 (26%)   6/23 (26%)   6/28 (21%)  10/34 (29%) |  3/33 (9%)    3/32 (9%)    4/31 (13%)   2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      548          691       |   452          733 (T)      708          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.068N     P=0.388N     P=0.150N     P=0.106N   |  P=0.344N     P=0.514N     P=0.473      P=0.315N   |
|INCIDENTAL TUMOR       |  P=0.053N     P=0.178N     P=0.059N     P=0.134N   |  P=0.363N     P=0.610N     P=0.424      P=0.337N   |
|LOGISTIC REGRESSION    |  P=0.048N*    P=0.147N     P=0.067N     P=0.096N   |  P=0.329N     P=0.487N     P=0.504      P=0.319N   |
|COCHRAN-ARMITAGE       |  P=0.050N*                                         |  P=0.367N                                          |
|FISHER EXACT           |               P=0.146N     P=0.065N     P=0.100N   |               P=0.500N     P=0.500      P=0.340N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)   9/60 (15%)   2/60 (3%)    7/60 (12%) |  1/60 (2%)    2/60 (3%)    6/60 (10%)   2/60 (3%)  |
|ADJUSTED (b)           |  22.1%        25.8%         7.1%        17.3%      |   3.0%         6.3%        17.1%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  5/34 (15%)   2/23 (9%)    2/28 (7%)    4/34 (12%) |  1/33 (3%)    2/32 (6%)    4/31 (13%)   2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   457 (I)      490          733 (T)      562       |   733 (T)      733 (T)      622          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.188N     P=0.422      P=0.052N     P=0.381N   |  P=0.242      P=0.489      P=0.054      P=0.521    |
|INCIDENTAL TUMOR       |  P=0.168N     P=0.457N     P=0.035N*    P=0.380N   |  P=0.230      P=0.489      P=0.071      P=0.521    |
|LOGISTIC REGRESSION    |  P=0.167N     P=0.591      P=0.031N*    P=0.388N   |  P=0.252      P=0.489      P=0.059      P=0.521    |
|COCHRAN-ARMITAGE       |  P=0.170N                                          |  P=0.223                                           |
|FISHER EXACT           |               P=0.601N     P=0.027N*    P=0.395N   |               P=0.500      P=0.057      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/60 (42%)  21/60 (35%)  12/60 (20%)  17/60 (28%) |  5/60 (8%)    5/60 (8%)   10/60 (17%)   3/60 (5%)  |
|ADJUSTED (b)           |  51.3%        56.2%        35.8%        43.5%      |  13.6%        15.6%        28.4%         8.6%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 12/34 (35%)   8/23 (35%)   8/28 (29%)  13/34 (38%) |  4/33 (12%)   5/32 (16%)   7/31 (23%)   3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      548          562       |   452          733 (T)      622          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.044N*    P=0.499      P=0.042N*    P=0.102N   |  P=0.491N     P=0.614      P=0.117      P=0.328N   |
|INCIDENTAL TUMOR       |  P=0.026N*    P=0.210N     P=0.008N**   P=0.111N   |  P=0.512N     P=0.536      P=0.116      P=0.347N   |
|LOGISTIC REGRESSION    |  P=0.024N*    P=0.291N     P=0.009N**   P=0.087N   |  P=0.471N     P=0.613N     P=0.134      P=0.325N   |
|COCHRAN-ARMITAGE       |  P=0.026N*                                         |  P=0.524N                                          |
|FISHER EXACT           |               P=0.287N     P=0.009N**   P=0.090N   |               P=0.628N     P=0.135      P=0.359N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/56 (4%)    0/56 (0%)    0/55 (0%)    0/58 (0%)  |
|ADJUSTED (b)           |                                                    |   6.9%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  2/29 (7%)    0/28 (0%)    0/28 (0%)    0/33 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.046N*    P=0.246N     P=0.246N     P=0.210N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.046N*    P=0.246N     P=0.246N     P=0.210N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.046N*    P=0.244N     P=0.246N     P=0.210N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.048N*                                         |
|FISHER EXACT           |                                                    |               P=0.248N     P=0.252N     P=0.239N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/58 (0%)    0/55 (0%)    0/59 (0%)    0/59 (0%)  |  5/58 (9%)   11/60 (18%)   8/59 (14%)   4/57 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  14.6%        29.6%        24.8%        12.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/32 (0%)    0/20 (0%)    0/28 (0%)    0/33 (0%)  |  4/33 (12%)   7/32 (22%)   7/31 (23%)   4/33 (12%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   698          397          717          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.480N     P=0.090      P=0.246      P=0.489N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.488N     P=0.071      P=0.252      P=0.484N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.430N     P=0.118      P=0.275      P=0.451N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.500N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.101      P=0.290      P=0.511N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%         0.0%      |   0.0%         0.0%         4.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    0/28 (0%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          727          ---       |   ---          ---          564          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600        (e)        P=0.466        (e)      |  P=0.480        (e)        P=0.245        (e)      |
|INCIDENTAL TUMOR       |  P=0.631        (e)        P=0.552        (e)      |  P=0.451        (e)        P=0.329        (e)      |
|LOGISTIC REGRESSION    |  P=0.607        (e)        P=0.482        (e)      |  P=0.449        (e)        P=0.235        (e)      |
|COCHRAN-ARMITAGE       |  P=0.608                                           |  P=0.461                                           |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |                 (e)        P=0.248        (e)      |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%         0.0%      |   3.0%         0.0%         4.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    0/28 (0%)    0/34 (0%)  |  1/33 (3%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          727          ---       |   733 (T)      ---          564          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600        (e)        P=0.466        (e)      |  P=0.482N     P=0.506N     P=0.498      P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.631        (e)        P=0.552        (e)      |  P=0.501N     P=0.506N     P=0.587      P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.607        (e)        P=0.482        (e)      |  P=0.500N     P=0.506N     P=0.501      P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.608                                           |  P=0.500N                                          |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%         0.0%      |   3.0%         0.0%         4.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    0/28 (0%)    0/34 (0%)  |  1/33 (3%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          727          ---       |   733 (T)      ---          564          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.600        (e)        P=0.466        (e)      |  P=0.482N     P=0.506N     P=0.498      P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.631        (e)        P=0.552        (e)      |  P=0.501N     P=0.506N     P=0.587      P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.607        (e)        P=0.482        (e)      |  P=0.500N     P=0.506N     P=0.501      P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.608                                           |  P=0.500N                                          |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         4.8%         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%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    0/28 (0%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          579          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.593N     P=0.256        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.635N     P=0.343        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.617N     P=0.237        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.615N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.248        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |  1/59 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.8%         0.0%         5.6%         2.1%      |   3.1%         0.0%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/23 (0%)    1/28 (4%)    0/34 (0%)  |  1/32 (3%)    0/32 (0%)    1/31 (3%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          562          618       |   733 (T)      ---          733 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.240N     P=0.197N     P=0.568N     P=0.303N   |  P=0.372N     P=0.500N     P=0.755      P=0.482N   |
|INCIDENTAL TUMOR       |  P=0.231N     P=0.197N     P=0.540N     P=0.307N   |  P=0.372N     P=0.500N     P=0.755      P=0.482N   |
|LOGISTIC REGRESSION    |  P=0.229N     P=0.197N     P=0.515N     P=0.299N   |  P=0.372N     P=0.500N     P=0.755      P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.230N                                          |  P=0.381N                                          |
|FISHER EXACT           |               P=0.122N     P=0.500N     P=0.309N   |               P=0.496N     P=0.748N     P=0.496N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  13
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.2%         0.0%         3.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    1/28 (4%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    0/31 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          733 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.140N     P=0.245N     P=0.534N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.128N     P=0.166N     P=0.492N     P=0.229N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.132N     P=0.231N     P=0.493N     P=0.244N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.132N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.500N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |                                                    |
|ADJUSTED (b)           |   2.4%         4.3%         0.0%         5.4%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |                                                    |
|TERMINAL (d)           |  0/34 (0%)    1/23 (4%)    0/28 (0%)    1/34 (3%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   671          733 (T)      ---          698       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.476      P=0.718      P=0.515N     P=0.514    |                                                    |
|INCIDENTAL TUMOR       |  P=0.477      P=0.736N     P=0.448N     P=0.522    |                                                    |
|LOGISTIC REGRESSION    |  P=0.476      P=0.756      P=0.502N     P=0.506    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.472                                           |                                                    |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.500    |                                                    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  14
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma Benign                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/57 (0%)    0/51 (0%)    0/53 (0%)    0/56 (0%)  |  1/58 (2%)    1/57 (2%)    2/58 (3%)    0/57 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   3.0%         2.1%         6.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/32 (0%)    0/20 (0%)    0/24 (0%)    0/32 (0%)  |  1/33 (3%)    0/31 (0%)    1/31 (3%)    0/32 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   733 (T)      564          730          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.466N     P=0.758N     P=0.482      P=0.506N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.468N     P=0.643N     P=0.472      P=0.506N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.472N     P=0.759      P=0.497      P=0.506N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.476N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.748      P=0.500      P=0.504N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/59 (3%)    1/60 (2%)    1/59 (2%)  |  3/60 (5%)    1/59 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   2.5%         9.1%         3.6%         3.0%      |   7.7%         3.2%         0.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/22 (9%)    1/28 (4%)    1/33 (3%)  |  2/33 (6%)    1/31 (3%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   691          733 (T)      733 (T)      733 (T)   |   456 (I)      733 (T)      ---          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.603N     P=0.394      P=0.727      P=0.758N   |  P=0.107N     P=0.323N     P=0.137N     P=0.291N   |
|INCIDENTAL TUMOR       |  P=0.604N     P=0.477      P=0.754N     P=0.753N   |  P=0.107N     P=0.323N     P=0.137N     P=0.291N   |
|LOGISTIC REGRESSION    |  P=0.600N     P=0.471      P=0.752      P=0.762N   |  P=0.103N     P=0.308N     P=0.121N     P=0.301N   |
|COCHRAN-ARMITAGE       |  P=0.602N                                          |  P=0.107N                                          |
|FISHER EXACT           |               P=0.494      P=0.752N     P=0.748    |               P=0.316N     P=0.122N     P=0.309N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  15
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/59 (3%)    1/60 (2%)    1/59 (2%)  |  3/60 (5%)    1/59 (2%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   2.5%         9.1%         3.6%         3.0%      |   7.7%         3.2%         0.0%         5.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/22 (9%)    1/28 (4%)    1/33 (3%)  |  2/33 (6%)    1/31 (3%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   691          733 (T)      733 (T)      733 (T)   |   456 (I)      733 (T)      ---          721       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.603N     P=0.394      P=0.727      P=0.758N   |  P=0.256N     P=0.323N     P=0.137N     P=0.467N   |
|INCIDENTAL TUMOR       |  P=0.604N     P=0.477      P=0.754N     P=0.753N   |  P=0.255N     P=0.323N     P=0.137N     P=0.466N   |
|LOGISTIC REGRESSION    |  P=0.600N     P=0.471      P=0.752      P=0.762N   |  P=0.255N     P=0.308N     P=0.121N     P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.602N                                          |  P=0.266N                                          |
|FISHER EXACT           |               P=0.494      P=0.752N     P=0.748    |               P=0.316N     P=0.122N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    3/60 (5%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%         8.5%         0.0%         5.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/33 (0%)    2/32 (6%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          648          ---          731       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.286      P=0.119        (e)        P=0.259    |
|INCIDENTAL TUMOR       |                                                    |  P=0.293      P=0.125        (e)        P=0.269    |
|LOGISTIC REGRESSION    |                                                    |  P=0.288      P=0.126        (e)        P=0.270    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.267                                           |
|FISHER EXACT           |                                                    |               P=0.122        (e)        P=0.248    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  16
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    4/60 (7%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%        10.7%         0.0%         5.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  0/33 (0%)    2/32 (6%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          648          ---          731       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.329      P=0.065        (e)        P=0.259    |
|INCIDENTAL TUMOR       |                                                    |  P=0.338      P=0.068        (e)        P=0.269    |
|LOGISTIC REGRESSION    |                                                    |  P=0.324      P=0.066        (e)        P=0.270    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.305                                           |
|FISHER EXACT           |                                                    |               P=0.059        (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    5/60 (8%)    0/60 (0%)    0/60 (0%)  |  3/60 (5%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   8.4%        14.0%         0.0%         0.0%      |   9.1%         0.0%         0.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  2/34 (6%)    1/23 (4%)    0/28 (0%)    0/34 (0%)  |  3/33 (9%)    0/32 (0%)    0/31 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   730          457 (I)      ---          ---       |   733 (T)      ---          ---          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.062N     P=0.254      P=0.163N     P=0.125N   |  P=0.092N     P=0.126N     P=0.132N     P=0.284N   |
|INCIDENTAL TUMOR       |  P=0.045N*    P=0.463      P=0.129N     P=0.117N   |  P=0.092N     P=0.126N     P=0.132N     P=0.284N   |
|LOGISTIC REGRESSION    |  P=0.052N     P=0.350      P=0.146N     P=0.118N   |  P=0.092N     P=0.126N     P=0.132N     P=0.284N   |
|COCHRAN-ARMITAGE       |  P=0.052N                                          |  P=0.094N                                          |
|FISHER EXACT           |               P=0.359      P=0.122N     P=0.122N   |               P=0.122N     P=0.122N     P=0.309N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  17
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    4/60 (7%)    5/60 (8%)  |  3/60 (5%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.8%         8.7%        11.0%        12.6%      |   9.1%         0.0%         3.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/23 (0%)    1/28 (4%)    2/34 (6%)  |  3/33 (9%)    0/32 (0%)    1/31 (3%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      686          562          618       |   733 (T)      ---          733 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.291      P=0.546      P=0.422      P=0.366    |  P=0.041N*    P=0.126N     P=0.327N     P=0.110N   |
|INCIDENTAL TUMOR       |  P=0.287      P=0.600N     P=0.512      P=0.371    |  P=0.041N*    P=0.126N     P=0.327N     P=0.110N   |
|LOGISTIC REGRESSION    |  P=0.284      P=0.638      P=0.485      P=0.369    |  P=0.041N*    P=0.126N     P=0.327N     P=0.110N   |
|COCHRAN-ARMITAGE       |  P=0.279                                           |  P=0.042N*                                         |
|FISHER EXACT           |               P=0.660N     P=0.500      P=0.359    |               P=0.122N     P=0.309N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   8/60 (13%)   4/60 (7%)    5/60 (8%)  |  5/60 (8%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  17.0%        21.7%        11.0%        12.6%      |  15.2%         0.0%         3.2%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  5/34 (15%)   1/23 (4%)    1/28 (4%)    2/34 (6%)  |  5/33 (15%)   0/32 (0%)    1/31 (3%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   730          457 (I)      562          618       |   733 (T)      ---          733 (T)      733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.370N     P=0.240      P=0.477N     P=0.496N   |  P=0.021N*    P=0.035N*    P=0.116N     P=0.089N   |
|INCIDENTAL TUMOR       |  P=0.336N     P=0.521      P=0.368N     P=0.482N   |  P=0.021N*    P=0.035N*    P=0.116N     P=0.089N   |
|LOGISTIC REGRESSION    |  P=0.354N     P=0.368      P=0.395N     P=0.482N   |  P=0.021N*    P=0.035N*    P=0.116N     P=0.089N   |
|COCHRAN-ARMITAGE       |  P=0.359N                                          |  P=0.023N*                                         |
|FISHER EXACT           |               P=0.389      P=0.372N     P=0.500N   |               P=0.029N*    P=0.103N     P=0.103N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  18
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.6%         0.0%      |   0.0%         0.0%         5.5%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/23 (0%)    1/28 (4%)    0/34 (0%)  |  0/33 (0%)    0/32 (0%)    1/31 (3%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      ---       |   ---          ---          640          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599        (e)        P=0.461        (e)      |  P=0.225        (e)        P=0.233      P=0.512    |
|INCIDENTAL TUMOR       |  P=0.599        (e)        P=0.461        (e)      |  P=0.188        (e)        P=0.321      P=0.512    |
|LOGISTIC REGRESSION    |  P=0.599        (e)        P=0.461        (e)      |  P=0.223        (e)        P=0.239      P=0.512    |
|COCHRAN-ARMITAGE       |  P=0.608                                           |  P=0.212                                           |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |                 (e)        P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    5/60 (8%)    4/60 (7%)    3/60 (5%)  |  9/60 (15%)   6/60 (10%)  15/60 (25%)   6/60 (10%) |
|ADJUSTED (b)           |   0.0%        15.5%        11.7%         8.1%      |  22.9%        17.2%        39.3%        16.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/23 (9%)    2/28 (7%)    2/34 (6%)  |  5/33 (15%)   4/32 (13%)   9/31 (29%)   5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   ---          631          601          691       |   452          698          533          681       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.131      P=0.022 *    P=0.052      P=0.126    |  P=0.438N     P=0.302N     P=0.120      P=0.250N   |
|INCIDENTAL TUMOR       |  P=0.123      P=0.035 *    P=0.071      P=0.129    |  P=0.463N     P=0.332N     P=0.107      P=0.239N   |
|LOGISTIC REGRESSION    |  P=0.122      P=0.032 *    P=0.060      P=0.125    |  P=0.432N     P=0.269N     P=0.126      P=0.247N   |
|COCHRAN-ARMITAGE       |  P=0.119                                           |  P=0.490N                                          |
|FISHER EXACT           |               P=0.029 *    P=0.059      P=0.122    |               P=0.291N     P=0.127      P=0.291N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  19
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    5/60 (8%)    3/60 (5%)    3/60 (5%)  |  9/60 (15%)   6/60 (10%)  13/60 (22%)   5/60 (8%)  |
|ADJUSTED (b)           |   0.0%        15.5%         8.3%         8.1%      |  22.9%        17.2%        35.0%        13.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/23 (9%)    1/28 (4%)    2/34 (6%)  |  5/33 (15%)   4/32 (13%)   8/31 (26%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   ---          631          601          691       |   452          698          533          681       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.148      P=0.022 *    P=0.108      P=0.126    |  P=0.300N     P=0.302N     P=0.223      P=0.168N   |
|INCIDENTAL TUMOR       |  P=0.139      P=0.035 *    P=0.147      P=0.129    |  P=0.312N     P=0.332N     P=0.187      P=0.157N   |
|LOGISTIC REGRESSION    |  P=0.138      P=0.032 *    P=0.119      P=0.125    |  P=0.288N     P=0.269N     P=0.241      P=0.165N   |
|COCHRAN-ARMITAGE       |  P=0.135                                           |  P=0.340N                                          |
|FISHER EXACT           |               P=0.029 *    P=0.122      P=0.122    |               P=0.291N     P=0.240      P=0.197N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/60 (75%)  41/60 (68%)  35/60 (58%)  32/60 (53%) | 29/60 (48%)  28/60 (47%)  27/60 (45%)  28/60 (47%) |
|ADJUSTED (b)           |  86.2%        97.5%        85.1%        74.2%      |  71.3%        71.2%        70.6%        64.8%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   3/10 (30%)   0/10 (0%)    0/10 (0%)  |  3/10 (30%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 27/34 (79%)  22/23 (96%)  22/28 (79%)  23/34 (68%) | 22/33 (67%)  21/32 (66%)  20/31 (65%)  20/35 (57%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      548          638       |   452          397          552          628       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.021N*    P=0.170      P=0.313N     P=0.024N*  |  P=0.339N     P=0.535N     P=0.529N     P=0.371N   |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.408N     P=0.049N*    P=0.010N** |  P=0.346N     P=0.556N     P=0.468N     P=0.423N   |
|LOGISTIC REGRESSION    |  P=0.002N**   P=0.286N     P=0.041N*    P=0.006N** |  P=0.294N     P=0.439N     P=0.404N     P=0.364N   |
|COCHRAN-ARMITAGE       |  P=0.005N**                                        |  P=0.436N                                          |
|FISHER EXACT           |               P=0.272N     P=0.040N*    P=0.011N*  |               P=0.500N     P=0.427N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  20
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.00500%     0.00700%     0.0100%   |   VEHICLE      0.00500%     0.00700%     0.0100%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/60 (42%)  29/60 (48%)  26/60 (43%)  29/60 (48%) | 23/60 (38%)  21/60 (35%)  30/60 (50%)  16/60 (27%) |
|ADJUSTED (b)           |  50.7%        62.7%        56.0%        57.6%      |  54.1%        48.1%        65.6%        38.8%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 11/34 (32%)   7/23 (30%)   9/28 (32%)  13/34 (38%) | 14/33 (42%)  10/32 (31%)  16/31 (52%)  11/35 (31%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      457 (I)      490          455 (I)   |   452          579          211          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.343      P=0.129      P=0.331      P=0.354    |  P=0.213N     P=0.441N     P=0.135      P=0.089N   |
|INCIDENTAL TUMOR       |  P=0.284      P=0.554N     P=0.444N     P=0.255    |  P=0.226N     P=0.279N     P=0.180      P=0.073N   |
|LOGISTIC REGRESSION    |  P=0.279      P=0.380      P=0.530N     P=0.253    |  P=0.202N     P=0.326N     P=0.134      P=0.074N   |
|COCHRAN-ARMITAGE       |  P=0.297                                           |  P=0.261N                                          |
|FISHER EXACT           |               P=0.291      P=0.500      P=0.291    |               P=0.425N     P=0.135      P=0.121N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/60 (82%)  52/60 (87%)  45/60 (75%)  42/60 (70%) | 38/60 (63%)  40/60 (67%)  43/60 (72%)  35/60 (58%) |
|ADJUSTED (b)           |  88.9%       100.0%        91.8%        83.8%      |  84.0%        86.8%        89.3%        75.8%      |
|INTERIM SACRIFICE 1 (c)|  7/10 (70%)   3/10 (30%)   0/10 (0%)    1/10 (10%) |  3/10 (30%)   0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           | 28/34 (82%)  23/23 (100%) 24/28 (86%)  26/34 (76%) | 26/33 (79%)  26/32 (81%)  26/31 (84%)  24/35 (69%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      490          455 (I)   |   452          397          211          385       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.174N     P=0.028 *    P=0.419      P=0.166N   |  P=0.317N     P=0.403      P=0.179      P=0.229N   |
|INCIDENTAL TUMOR       |  P=0.032N*    P=0.305      P=0.189N     P=0.090N   |  P=0.359N     P=0.517      P=0.280      P=0.210N   |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.274      P=0.224N     P=0.083N   |  P=0.290N     P=0.509      P=0.210      P=0.198N   |
|COCHRAN-ARMITAGE       |  P=0.058N                                          |  P=0.434N                                          |
|FISHER EXACT           |               P=0.309      P=0.253N     P=0.100N   |               P=0.424      P=0.218      P=0.354N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  21
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (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):   455
          Female interim sacrifices(days): 455
 (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).
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:22:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                    CORE STUDY HIGH DOSE GROUPS                                                     
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 005    0.0200%                                                                       
                                       INCLUDE 007    0.0200%                                                                       
                                       INCLUDE 017    0.0275%                                                                       
                                       INCLUDE 019    0.0275%                                                                       
                                       INCLUDE 021    0.0140%                                                                       
                                       INCLUDE 023    0.0140%                                                                       
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94      
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:22:53      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B      
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 09/21/94       
EXPERIMENT: 05089 TEST: 02                                                                                     TIME: 15:22:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-45037          ROUTE: DOSED WATER                                                                 NTP C#: 56382B       
PATHOLOGIST: J. HEATH                        S. EUSTIS                                                         CAS: 10599903        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF CHLORAMINE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Spleen                        Hemangiosarcoma
                             All Organs                    Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Uterus                        Polyp Stromal
                             All Organs                    Hemangiosarcoma
                                                           Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   1
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    2/60 (3%)    1/60 (2%)    6/60 (10%) |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.9%         5.7%         2.7%        18.0%      |   0.0%         0.0%         2.1%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   2/35 (6%)    1/37 (3%)    5/32 (16%) |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   681          733 (T)      733 (T)      702       |   ---          ---          647          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.563N     P=0.208N     P=0.089N     P=0.464    |  P=0.603        (e)        P=0.527        (e)      |
|INCIDENTAL TUMOR       |  P=0.563N     P=0.220N     P=0.101N     P=0.477    |  P=0.561        (e)        P=0.419        (e)      |
|LOGISTIC REGRESSION    |  P=0.562N     P=0.218N     P=0.093N     P=0.471    |  P=0.593        (e)        P=0.498        (e)      |
|COCHRAN-ARMITAGE       |  P=0.552N                                          |  P=0.593                                           |
|FISHER EXACT           |               P=0.219N     P=0.103N     P=0.500    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.9%         4.5%         0.0%         2.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   731          268          ---          491       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.498N     P=0.495      P=0.453N     P=0.754N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.620N     P=0.687      P=0.581N     P=0.749N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.563N     P=0.500      P=0.460N     P=0.754    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.520N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   2
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    4/60 (7%)    5/60 (8%)    0/60 (0%)  |  1/60 (2%)    1/60 (2%)    4/60 (7%)    4/60 (7%)  |
|ADJUSTED (b)           |   8.8%         9.9%        13.1%         0.0%      |   3.0%         2.6%         8.5%         9.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  3/34 (9%)    2/35 (6%)    4/37 (11%)   0/32 (0%)  |  1/33 (3%)    0/28 (0%)    2/42 (5%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      558          731          ---       |   733 (T)      681          455 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.271N     P=0.508      P=0.405      P=0.131N   |  P=0.104      P=0.736      P=0.244      P=0.198    |
|INCIDENTAL TUMOR       |  P=0.287N     P=0.508      P=0.373      P=0.131N   |  P=0.082      P=0.748N     P=0.201      P=0.187    |
|LOGISTIC REGRESSION    |  P=0.273N     P=0.497      P=0.404      P=0.130N   |  P=0.086      P=0.758      P=0.185      P=0.185    |
|COCHRAN-ARMITAGE       |  P=0.264N                                          |  P=0.083                                           |
|FISHER EXACT           |               P=0.500      P=0.359      P=0.122N   |               P=0.752N     P=0.182      P=0.182    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    4/60 (7%)    5/60 (8%)    1/60 (2%)  |  1/60 (2%)    2/60 (3%)    4/60 (7%)    4/60 (7%)  |
|ADJUSTED (b)           |   8.8%         9.9%        13.1%         2.3%      |   3.0%         5.8%         8.5%         9.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  3/34 (9%)    2/35 (6%)    4/37 (11%)   0/32 (0%)  |  1/33 (3%)    0/28 (0%)    2/42 (5%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      558          731          675       |   733 (T)      681          455 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.403N     P=0.508      P=0.405      P=0.318N   |  P=0.126      P=0.465      P=0.244      P=0.198    |
|INCIDENTAL TUMOR       |  P=0.422N     P=0.508      P=0.373      P=0.314N   |  P=0.093      P=0.548      P=0.201      P=0.187    |
|LOGISTIC REGRESSION    |  P=0.408N     P=0.497      P=0.404      P=0.319N   |  P=0.104      P=0.492      P=0.185      P=0.185    |
|COCHRAN-ARMITAGE       |  P=0.395N                                          |  P=0.100                                           |
|FISHER EXACT           |               P=0.500      P=0.359      P=0.309N   |               P=0.500      P=0.182      P=0.182    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   3
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    2/60 (3%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         5.2%         8.4%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/34 (3%)    0/35 (0%)    1/37 (3%)    1/32 (3%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      ---          731          691       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.167      P=0.494N     P=0.532      P=0.292    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.173      P=0.494N     P=0.479      P=0.312    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.164      P=0.494N     P=0.530      P=0.290    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.170                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.2%         6.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    1/37 (3%)    1/32 (3%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          731          731       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.089        (e)        P=0.261      P=0.230    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.097        (e)        P=0.209      P=0.243    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.086        (e)        P=0.255      P=0.221    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.093                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   4
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         3.1%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    2/37 (5%)    1/32 (3%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      733 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.196        (e)        P=0.257      P=0.488    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.196        (e)        P=0.257      P=0.488    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.196        (e)        P=0.257      P=0.488    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.204                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         5.4%         6.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    2/37 (5%)    2/32 (6%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          733 (T)      733 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.086        (e)        P=0.257      P=0.225    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.086        (e)        P=0.257      P=0.225    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.086        (e)        P=0.257      P=0.225    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.093                                           |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.248      P=0.248    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   5
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    2/60 (3%)    1/60 (2%)  |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         4.1%         4.4%         3.1%      |   3.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/34 (3%)    0/35 (0%)    0/37 (0%)    1/32 (3%)  |  1/33 (3%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      540          586          733 (T)   |   733 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.556      P=0.503      P=0.523      P=0.748    |  P=0.187N     P=0.533N     P=0.452N     P=0.488N   |
|INCIDENTAL TUMOR       |  P=0.573      P=0.524      P=0.443      P=0.748    |  P=0.187N     P=0.533N     P=0.452N     P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.456      P=0.503      P=0.500      P=0.748    |  P=0.187N     P=0.533N     P=0.452N     P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.561                                           |  P=0.203N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.752N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/60 (55%)  28/60 (47%)  21/60 (35%)  28/60 (47%) | 20/60 (33%)  18/60 (30%)  13/60 (22%)  23/60 (38%) |
|ADJUSTED (b)           |  72.7%        67.8%        45.2%        65.3%      |  54.6%        53.7%        29.4%        62.1%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   2/9 (22%)    3/9 (33%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 22/34 (65%)  22/35 (63%)  13/37 (35%)  18/32 (56%) | 17/33 (52%)  13/28 (46%)  11/42 (26%)  21/35 (60%) |
|FIRST INCIDENCE (DAYS) |   457 (I)      457 (I)      353          456 (I)   |   457 (I)      658          675          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.132N     P=0.209N     P=0.018N*    P=0.350N   |  P=0.368N     P=0.537      P=0.021N*    P=0.434    |
|INCIDENTAL TUMOR       |  P=0.093N     P=0.221N     P=0.016N*    P=0.304N   |  P=0.451N     P=0.530N     P=0.038N*    P=0.393    |
|LOGISTIC REGRESSION    |  P=0.112N     P=0.229N     P=0.021N*    P=0.287N   |  P=0.455N     P=0.456N     P=0.047N*    P=0.397    |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |  P=0.501                                           |
|FISHER EXACT           |               P=0.233N     P=0.022N*    P=0.233N   |               P=0.422N     P=0.110N     P=0.352    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   6
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 14/60 (23%)  16/60 (27%)  11/60 (18%)  15/60 (25%) |  6/60 (10%)   7/60 (12%)   3/60 (5%)    5/60 (8%)  |
|ADJUSTED (b)           |  29.4%        32.7%        25.5%        30.6%      |  17.2%        20.1%         6.9%        13.5%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   0/9 (0%)     1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   5/35 (14%)   7/37 (19%)   3/32 (9%)  |  5/33 (15%)   3/28 (11%)   2/42 (5%)    3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      455 (I)      443          358       |   659          558          691          727       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.529      P=0.428      P=0.303N     P=0.455    |  P=0.251N     P=0.415      P=0.150N     P=0.460N   |
|INCIDENTAL TUMOR       |  P=0.447N     P=0.396      P=0.355N     P=0.490N   |  P=0.329N     P=0.520      P=0.196N     P=0.492N   |
|LOGISTIC REGRESSION    |  P=0.452      P=0.421      P=0.495N     P=0.421    |  P=0.276N     P=0.482      P=0.181N     P=0.468N   |
|COCHRAN-ARMITAGE       |  P=0.515N                                          |  P=0.322N                                          |
|FISHER EXACT           |               P=0.417      P=0.327N     P=0.500    |               P=0.500      P=0.245N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/60 (25%)  16/60 (27%)  12/60 (20%)  15/60 (25%) |  6/60 (10%)   7/60 (12%)   3/60 (5%)    5/60 (8%)  |
|ADJUSTED (b)           |  31.2%        32.7%        27.4%        30.6%      |  17.2%        20.1%         6.9%        13.5%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   0/9 (0%)     1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/34 (12%)   5/35 (14%)   7/37 (19%)   3/32 (9%)  |  5/33 (15%)   3/28 (11%)   2/42 (5%)    3/35 (9%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      455 (I)      443          358       |   659          558          691          727       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.489N     P=0.504      P=0.304N     P=0.529    |  P=0.251N     P=0.415      P=0.150N     P=0.460N   |
|INCIDENTAL TUMOR       |  P=0.379N     P=0.472      P=0.388N     P=0.389N   |  P=0.329N     P=0.520      P=0.196N     P=0.492N   |
|LOGISTIC REGRESSION    |  P=0.513      P=0.508      P=0.507N     P=0.500    |  P=0.276N     P=0.482      P=0.181N     P=0.468N   |
|COCHRAN-ARMITAGE       |  P=0.451N                                          |  P=0.322N                                          |
|FISHER EXACT           |               P=0.500      P=0.331N     P=0.583N   |               P=0.500      P=0.245N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   7
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/60 (67%)  38/60 (63%)  27/60 (45%)  38/60 (63%) | 21/60 (35%)  23/60 (38%)  15/60 (25%)  24/60 (40%) |
|ADJUSTED (b)           |  78.0%        75.4%        56.2%        76.5%      |  55.8%        63.0%        34.0%        63.2%      |
|INTERIM SACRIFICE 1 (c)|  5/10 (50%)   5/10 (50%)   2/9 (22%)    4/9 (44%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 23/34 (68%)  23/35 (66%)  17/37 (46%)  21/32 (66%) | 17/33 (52%)  15/28 (54%)  13/42 (31%)  21/35 (60%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      455 (I)      353          358       |   457 (I)      558          675          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.264N     P=0.406N     P=0.018N*    P=0.549    |  P=0.352N     P=0.233      P=0.034N*    P=0.440    |
|INCIDENTAL TUMOR       |  P=0.143N     P=0.429N     P=0.011N*    P=0.351N   |  P=0.468N     P=0.352      P=0.063N     P=0.386    |
|LOGISTIC REGRESSION    |  P=0.183N     P=0.428N     P=0.013N*    P=0.469N   |  P=0.445N     P=0.369      P=0.072N     P=0.398    |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |  P=0.506                                           |
|FISHER EXACT           |               P=0.424N     P=0.013N*    P=0.424N   |               P=0.425      P=0.160N     P=0.353    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 40/60 (67%)  38/60 (63%)  28/60 (47%)  38/60 (63%) | 21/60 (35%)  23/60 (38%)  15/60 (25%)  24/60 (40%) |
|ADJUSTED (b)           |  78.0%        75.4%        57.4%        76.5%      |  55.8%        63.0%        34.0%        63.2%      |
|INTERIM SACRIFICE 1 (c)|  5/10 (50%)   5/10 (50%)   2/9 (22%)    4/9 (44%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 23/34 (68%)  23/35 (66%)  17/37 (46%)  21/32 (66%) | 17/33 (52%)  15/28 (54%)  13/42 (31%)  21/35 (60%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      455 (I)      353          358       |   457 (I)      558          675          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.282N     P=0.406N     P=0.027N*    P=0.549    |  P=0.352N     P=0.233      P=0.034N*    P=0.440    |
|INCIDENTAL TUMOR       |  P=0.156N     P=0.429N     P=0.019N*    P=0.351N   |  P=0.468N     P=0.352      P=0.063N     P=0.386    |
|LOGISTIC REGRESSION    |  P=0.200N     P=0.428N     P=0.021N*    P=0.469N   |  P=0.445N     P=0.369      P=0.072N     P=0.398    |
|COCHRAN-ARMITAGE       |  P=0.180N                                          |  P=0.506                                           |
|FISHER EXACT           |               P=0.424N     P=0.021N*    P=0.424N   |               P=0.425      P=0.160N     P=0.353    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   8
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 18/60 (30%)  17/60 (28%)   6/60 (10%)  15/60 (25%) |  4/60 (7%)    2/60 (3%)    3/60 (5%)    3/60 (5%)  |
|ADJUSTED (b)           |  39.4%        41.3%        12.9%        35.6%      |  10.6%         6.2%         7.0%         6.5%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   2/10 (20%)   2/9 (22%)    2/9 (22%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  9/34 (26%)  12/35 (34%)   2/37 (5%)    7/32 (22%) |  3/33 (9%)    1/28 (4%)    2/42 (5%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      455 (I)      457 (I)   |   452          716          732          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.136N     P=0.478N     P=0.007N**   P=0.426N   |  P=0.364N     P=0.386N     P=0.388N     P=0.479N   |
|INCIDENTAL TUMOR       |  P=0.128N     P=0.482N     P=0.008N**   P=0.376N   |  P=0.407N     P=0.420N     P=0.600N     P=0.447N   |
|LOGISTIC REGRESSION    |  P=0.104N     P=0.501N     P=0.006N**   P=0.342N   |  P=0.411N     P=0.345N     P=0.468N     P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.103N                                          |  P=0.419N                                          |
|FISHER EXACT           |               P=0.500N     P=0.006N**   P=0.342N   |               P=0.340N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)   6/60 (10%)   3/60 (5%)    8/60 (13%) |  1/60 (2%)    5/60 (8%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |  22.1%        15.4%         7.7%        25.0%      |   3.0%        15.3%         0.0%         5.2%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/34 (15%)   4/35 (11%)   2/37 (5%)    8/32 (25%) |  1/33 (3%)    3/28 (11%)   0/42 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   457 (I)      558          726          733 (T)   |   733 (T)      658          ---          673       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.293N     P=0.287N     P=0.057N     P=0.552N   |  P=0.576N     P=0.085      P=0.452N     P=0.516    |
|INCIDENTAL TUMOR       |  P=0.313N     P=0.294N     P=0.082N     P=0.563N   |  P=0.573      P=0.100      P=0.452N     P=0.500    |
|LOGISTIC REGRESSION    |  P=0.292N     P=0.292N     P=0.062N     P=0.534N   |  P=0.599      P=0.098      P=0.452N     P=0.512    |
|COCHRAN-ARMITAGE       |  P=0.277N                                          |  P=0.571                                           |
|FISHER EXACT           |               P=0.291N     P=0.063N     P=0.500N   |               P=0.103      P=0.500N     P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE   9
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/60 (42%)  23/60 (38%)   9/60 (15%)  21/60 (35%) |  5/60 (8%)    7/60 (12%)   3/60 (5%)    5/60 (8%)  |
|ADJUSTED (b)           |  51.3%        53.6%        19.8%        51.1%      |  13.6%        20.9%         7.0%        11.5%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   2/10 (20%)   2/9 (22%)    2/9 (22%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           | 12/34 (35%)  16/35 (46%)   4/37 (11%)  13/32 (41%) |  4/33 (12%)   4/28 (14%)   2/42 (5%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      455 (I)      457 (I)   |   452          658          732          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.093N     P=0.410N     P=0.002N**   P=0.393N   |  P=0.378N     P=0.315      P=0.249N     P=0.601N   |
|INCIDENTAL TUMOR       |  P=0.086N     P=0.415N     P=0.002N**   P=0.349N   |  P=0.442N     P=0.315      P=0.419N     P=0.586N   |
|LOGISTIC REGRESSION    |  P=0.067N     P=0.428N     P=0.001N**   P=0.306N   |  P=0.431N     P=0.363      P=0.319N     P=0.629    |
|COCHRAN-ARMITAGE       |  P=0.062N                                          |  P=0.454N                                          |
|FISHER EXACT           |               P=0.426N     P=0.001N**   P=0.287N   |               P=0.381      P=0.359N     P=0.628N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/56 (4%)    0/58 (0%)    1/57 (2%)    0/56 (0%)  |
|ADJUSTED (b)           |                                                    |   6.9%         0.0%         2.5%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |                                                    |  2/29 (7%)    0/26 (0%)    1/40 (3%)    0/31 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   733 (T)      ---          733 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.108N     P=0.262N     P=0.388N     P=0.223N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.108N     P=0.262N     P=0.388N     P=0.223N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.108N     P=0.262N     P=0.388N     P=0.223N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.133N                                          |
|FISHER EXACT           |                                                    |               P=0.239N     P=0.493N     P=0.248N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  10
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/58 (0%)    0/59 (0%)    0/59 (0%)    0/58 (0%)  |  5/58 (9%)    4/58 (7%)    2/60 (3%)    6/60 (10%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  14.6%        14.8%         4.8%        15.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/32 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  4/33 (12%)   4/27 (15%)   2/42 (5%)    5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   698          733 (T)      733 (T)      457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.478N     P=0.608N     P=0.133N     P=0.541    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.493N     P=0.584N     P=0.156N     P=0.548    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.514N     P=0.518N     P=0.150N     P=0.531    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.542N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.206N     P=0.524    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/58 (0%)    0/59 (0%)    0/59 (0%)    0/58 (0%)  |  5/58 (9%)    4/58 (7%)    3/60 (5%)    6/60 (10%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  14.6%        14.8%         7.1%        15.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/32 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  4/33 (12%)   4/27 (15%)   3/42 (7%)    5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   698          733 (T)      733 (T)      457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.519N     P=0.608N     P=0.235N     P=0.541    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.533N     P=0.584N     P=0.265N     P=0.548    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.555N     P=0.518N     P=0.260N     P=0.531    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.551                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.340N     P=0.524    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  11
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    3/60 (5%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.2%         0.0%      |   0.0%         8.0%         0.0%         2.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    1/28 (4%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          625          ---       |   ---          453          ---          686       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.589        (e)        P=0.504        (e)      |  P=0.507      P=0.113        (e)        P=0.505    |
|INCIDENTAL TUMOR       |  P=0.529        (e)        P=0.455        (e)      |  P=0.452      P=0.090        (e)        P=0.477    |
|LOGISTIC REGRESSION    |  P=0.601        (e)        P=0.502        (e)      |  P=0.479      P=0.121        (e)        P=0.504    |
|COCHRAN-ARMITAGE       |  P=0.593                                           |  P=0.480                                           |
|FISHER EXACT           |                 (e)        P=0.500        (e)      |               P=0.122        (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         2.9%         2.2%         0.0%      |   3.0%         8.0%         2.4%         2.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/35 (3%)    0/37 (0%)    0/32 (0%)  |  1/33 (3%)    1/28 (4%)    1/42 (2%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      625          ---       |   733 (T)      453          733 (T)      686       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599      P=0.506      P=0.504        (e)      |  P=0.530N     P=0.278      P=0.707N     P=0.751N   |
|INCIDENTAL TUMOR       |  P=0.557      P=0.506      P=0.455        (e)      |  P=0.574N     P=0.244      P=0.707N     P=0.754    |
|LOGISTIC REGRESSION    |  P=0.601      P=0.506      P=0.502        (e)      |  P=0.560N     P=0.303      P=0.708N     P=0.756N   |
|COCHRAN-ARMITAGE       |  P=0.604                                           |  P=0.569N                                          |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.309      P=0.752N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  12
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |  1/60 (2%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         2.9%         2.2%         0.0%      |   3.0%         8.0%         2.4%         2.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/35 (3%)    0/37 (0%)    0/32 (0%)  |  1/33 (3%)    1/28 (4%)    1/42 (2%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      625          ---       |   733 (T)      453          733 (T)      686       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.599      P=0.506      P=0.504        (e)      |  P=0.530N     P=0.278      P=0.707N     P=0.751N   |
|INCIDENTAL TUMOR       |  P=0.557      P=0.506      P=0.455        (e)      |  P=0.574N     P=0.244      P=0.707N     P=0.754    |
|LOGISTIC REGRESSION    |  P=0.601      P=0.506      P=0.502        (e)      |  P=0.560N     P=0.303      P=0.708N     P=0.756N   |
|COCHRAN-ARMITAGE       |  P=0.604                                           |  P=0.569N                                          |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.309      P=0.752N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |  1/59 (2%)    1/59 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.8%         2.3%         0.0%         0.0%      |   3.1%         3.6%         2.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  1/32 (3%)    1/28 (4%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      648          ---          ---       |   733 (T)      733 (T)      675          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.021N*    P=0.301N     P=0.106N     P=0.131N   |  P=0.351N     P=0.732      P=0.714N     P=0.482N   |
|INCIDENTAL TUMOR       |  P=0.023N*    P=0.318N     P=0.106N     P=0.131N   |  P=0.373N     P=0.732      P=0.749      P=0.482N   |
|LOGISTIC REGRESSION    |  P=0.022N*    P=0.308N     P=0.106N     P=0.130N   |  P=0.360N     P=0.734      P=0.740N     P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.021N*                                         |  P=0.379N                                          |
|FISHER EXACT           |               P=0.309N     P=0.122N     P=0.122N   |               P=0.752N     P=0.748N     P=0.496N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  13
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   4.2%         2.9%         0.0%         3.1%      |   0.0%         0.0%         0.0%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/35 (3%)    0/37 (0%)    1/32 (3%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      733 (T)      ---          733 (T)   |   ---          ---          ---          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.268N     P=0.497N     P=0.246N     P=0.522N   |  P=0.126        (e)          (e)        P=0.251    |
|INCIDENTAL TUMOR       |  P=0.271N     P=0.522N     P=0.291N     P=0.508N   |  P=0.126        (e)          (e)        P=0.251    |
|LOGISTIC REGRESSION    |  P=0.256N     P=0.498N     P=0.225N     P=0.485N   |  P=0.126        (e)          (e)        P=0.251    |
|COCHRAN-ARMITAGE       |  P=0.258N                                          |  P=0.112                                           |
|FISHER EXACT           |               P=0.500N     P=0.248N     P=0.500N   |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   4.2%         2.9%         0.0%         0.0%      |   0.0%         0.0%         0.0%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    1/35 (3%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      733 (T)      ---          ---       |   ---          ---          ---          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.078N     P=0.497N     P=0.246N     P=0.254N   |  P=0.323        (e)          (e)        P=0.512    |
|INCIDENTAL TUMOR       |  P=0.083N     P=0.522N     P=0.291N     P=0.241N   |  P=0.323        (e)          (e)        P=0.512    |
|LOGISTIC REGRESSION    |  P=0.069N     P=0.498N     P=0.225N     P=0.199N   |  P=0.323        (e)          (e)        P=0.512    |
|COCHRAN-ARMITAGE       |  P=0.074N                                          |  P=0.305                                           |
|FISHER EXACT           |               P=0.500N     P=0.248N     P=0.248N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  14
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    3/59 (5%)    0/60 (0%)  |  3/60 (5%)    0/60 (0%)    0/59 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   2.5%         5.7%         8.3%         0.0%      |   7.7%         0.0%         0.0%         5.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/35 (6%)    3/36 (8%)    0/32 (0%)  |  2/33 (6%)    0/28 (0%)    0/42 (0%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   691          733 (T)      733 (T)      ---       |   456 (I)      ---          ---          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.556N     P=0.507      P=0.326      P=0.505N   |  P=0.222N     P=0.143N     P=0.096N     P=0.474N   |
|INCIDENTAL TUMOR       |  P=0.554N     P=0.481      P=0.290      P=0.481N   |  P=0.245N     P=0.143N     P=0.096N     P=0.495N   |
|LOGISTIC REGRESSION    |  P=0.554N     P=0.497      P=0.310      P=0.506N   |  P=0.249N     P=0.121N     P=0.126N     P=0.494N   |
|COCHRAN-ARMITAGE       |  P=0.547N                                          |  P=0.254N                                          |
|FISHER EXACT           |               P=0.500      P=0.303      P=0.500N   |               P=0.122N     P=0.125N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    3/59 (5%)    0/60 (0%)  |  3/60 (5%)    0/60 (0%)    0/59 (0%)    3/60 (5%)  |
|ADJUSTED (b)           |   2.5%         5.7%         8.3%         0.0%      |   7.7%         0.0%         0.0%         8.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    2/35 (6%)    3/36 (8%)    0/32 (0%)  |  2/33 (6%)    0/28 (0%)    0/42 (0%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   691          733 (T)      733 (T)      ---       |   456 (I)      ---          ---          704       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.556N     P=0.507      P=0.326      P=0.505N   |  P=0.412N     P=0.143N     P=0.096N     P=0.634N   |
|INCIDENTAL TUMOR       |  P=0.554N     P=0.481      P=0.290      P=0.481N   |  P=0.437N     P=0.143N     P=0.096N     P=0.652N   |
|LOGISTIC REGRESSION    |  P=0.554N     P=0.497      P=0.310      P=0.506N   |  P=0.446N     P=0.121N     P=0.126N     P=0.654N   |
|COCHRAN-ARMITAGE       |  P=0.547N                                          |  P=0.457N                                          |
|FISHER EXACT           |               P=0.500      P=0.303      P=0.500N   |               P=0.122N     P=0.125N     P=0.660N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  15
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    1/60 (2%)    1/60 (2%)    4/60 (7%)  |
|ADJUSTED (b)           |                                                    |   0.0%         2.4%         2.4%         9.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |                                                    |  0/33 (0%)    0/28 (0%)    1/42 (2%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          561          733 (T)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.040 *    P=0.486      P=0.548      P=0.072    |
|INCIDENTAL TUMOR       |                                                    |  P=0.019 *    P=0.602      P=0.548      P=0.052    |
|LOGISTIC REGRESSION    |                                                    |  P=0.024 *    P=0.498      P=0.548      P=0.058    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.033 *                                         |
|FISHER EXACT           |                                                    |               P=0.500      P=0.500      P=0.059    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |  3/60 (5%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   8.4%         2.3%         0.0%         4.8%      |   9.1%         0.0%         2.4%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/34 (6%)    0/35 (0%)    0/37 (0%)    1/32 (3%)  |  3/33 (9%)    0/28 (0%)    1/42 (2%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   730          626          ---          358       |   733 (T)      ---          733 (T)      733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.260N     P=0.305N     P=0.110N     P=0.525N   |  P=0.289N     P=0.151N     P=0.223N     P=0.473N   |
|INCIDENTAL TUMOR       |  P=0.145N     P=0.306N     P=0.133N     P=0.314N   |  P=0.289N     P=0.151N     P=0.223N     P=0.473N   |
|LOGISTIC REGRESSION    |  P=0.250N     P=0.307N     P=0.106N     P=0.502N   |  P=0.289N     P=0.151N     P=0.223N     P=0.473N   |
|COCHRAN-ARMITAGE       |  P=0.253N                                          |  P=0.337N                                          |
|FISHER EXACT           |               P=0.309N     P=0.122N     P=0.500N   |               P=0.122N     P=0.309N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  16
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    3/60 (5%)    1/60 (2%)  |  3/60 (5%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.8%         6.4%         6.4%         3.1%      |   9.1%         6.5%         2.2%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/34 (9%)    0/35 (0%)    0/37 (0%)    1/32 (3%)  |  3/33 (9%)    1/28 (4%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   733 (T)      540          586          733 (T)   |   733 (T)      730          675          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.297N     P=0.655N     P=0.627N     P=0.326N   |  P=0.050N*    P=0.562N     P=0.234N     P=0.110N   |
|INCIDENTAL TUMOR       |  P=0.300N     P=0.656N     P=0.621      P=0.326N   |  P=0.060N     P=0.534N     P=0.277N     P=0.110N   |
|LOGISTIC REGRESSION    |  P=0.393N     P=0.662N     P=0.662N     P=0.326N   |  P=0.052N     P=0.500N     P=0.260N     P=0.110N   |
|COCHRAN-ARMITAGE       |  P=0.290N                                          |  P=0.063N                                          |
|FISHER EXACT           |               P=0.660N     P=0.660N     P=0.309N   |               P=0.500N     P=0.309N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   4/60 (7%)    3/60 (5%)    3/60 (5%)  |  5/60 (8%)    2/60 (3%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  17.0%         8.5%         6.4%         7.8%      |  15.2%         6.5%         4.5%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/34 (15%)   0/35 (0%)    0/37 (0%)    2/32 (6%)  |  5/33 (15%)   1/28 (4%)    1/42 (2%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |   730          540          586          358       |   733 (T)      730          675          733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.159N     P=0.368N     P=0.215N     P=0.274N   |  P=0.085N     P=0.278N     P=0.137N     P=0.191N   |
|INCIDENTAL TUMOR       |  P=0.104N     P=0.368N     P=0.284N     P=0.148N   |  P=0.096N     P=0.258N     P=0.161N     P=0.191N   |
|LOGISTIC REGRESSION    |  P=0.146N     P=0.372N     P=0.240N     P=0.260N   |  P=0.089N     P=0.215N     P=0.158N     P=0.191N   |
|COCHRAN-ARMITAGE       |  P=0.149N                                          |  P=0.116N                                          |
|FISHER EXACT           |               P=0.372N     P=0.245N     P=0.245N   |               P=0.219N     P=0.219N     P=0.219N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  17
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         3.6%         4.8%         2.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    1/28 (4%)    2/42 (5%)    1/35 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          733 (T)      733 (T)      733 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.291      P=0.467      P=0.293      P=0.512    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.291      P=0.467      P=0.293      P=0.512    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.291      P=0.467      P=0.292      P=0.512    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.258                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.248      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    2/60 (3%)    4/60 (7%)  |  9/60 (15%)   9/60 (15%)  16/60 (27%)   7/60 (12%) |
|ADJUSTED (b)           |   0.0%         8.6%         5.1%        11.8%      |  22.9%        26.5%        38.1%        18.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    3/35 (9%)    1/37 (3%)    3/32 (9%)  |  5/33 (15%)   5/28 (18%)  16/42 (38%)   5/35 (14%) |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      727          694       |   452          575          733 (T)      651       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.053      P=0.126      P=0.255      P=0.058    |  P=0.471N     P=0.509      P=0.229      P=0.359N   |
|INCIDENTAL TUMOR       |  P=0.056      P=0.126      P=0.209      P=0.062    |  P=0.540      P=0.598      P=0.113      P=0.381N   |
|LOGISTIC REGRESSION    |  P=0.053      P=0.126      P=0.251      P=0.057    |  P=0.537N     P=0.583      P=0.142      P=0.371N   |
|COCHRAN-ARMITAGE       |  P=0.058                                           |  P=0.492                                           |
|FISHER EXACT           |               P=0.122      P=0.248      P=0.059    |               P=0.601N     P=0.088      P=0.395N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  18
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    3/60 (5%)    2/60 (3%)    4/60 (7%)  |  9/60 (15%)   8/60 (13%)  14/60 (23%)   6/60 (10%) |
|ADJUSTED (b)           |   0.0%         8.6%         5.1%        11.8%      |  22.9%        23.3%        33.3%        15.9%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    3/35 (9%)    1/37 (3%)    3/32 (9%)  |  5/33 (15%)   4/28 (14%)  14/42 (33%)   4/35 (11%) |
|FIRST INCIDENCE (DAYS) |   ---          733 (T)      727          694       |   452          575          733 (T)      651       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.053      P=0.126      P=0.255      P=0.058    |  P=0.347N     P=0.583N     P=0.364      P=0.264N   |
|INCIDENTAL TUMOR       |  P=0.056      P=0.126      P=0.209      P=0.062    |  P=0.430N     P=0.496N     P=0.208      P=0.279N   |
|LOGISTIC REGRESSION    |  P=0.053      P=0.126      P=0.251      P=0.057    |  P=0.403N     P=0.519N     P=0.255      P=0.270N   |
|COCHRAN-ARMITAGE       |  P=0.058                                           |  P=0.466N                                          |
|FISHER EXACT           |               P=0.122      P=0.248      P=0.059    |               P=0.500N     P=0.177      P=0.291N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.9%         4.5%         0.0%         2.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   731          268          ---          491       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.498N     P=0.495      P=0.453N     P=0.754N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.620N     P=0.687      P=0.581N     P=0.749N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.563N     P=0.500      P=0.460N     P=0.754    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.520N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.752N   |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  19
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   2.9%         4.5%         0.0%         2.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/9 (0%)     0/9 (0%)   |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/34 (0%)    0/35 (0%)    0/37 (0%)    0/32 (0%)  |  0/33 (0%)    0/28 (0%)    0/42 (0%)    0/35 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   731          268          ---          491       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.498N     P=0.495      P=0.453N     P=0.754N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.620N     P=0.687      P=0.581N     P=0.749N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.563N     P=0.500      P=0.460N     P=0.754    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.520N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500N     P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/60 (75%)  40/60 (67%)  31/60 (52%)  38/60 (63%) | 29/60 (48%)  23/60 (38%)  22/60 (37%)  36/60 (60%) |
|ADJUSTED (b)           |  86.2%        84.8%        63.5%        81.9%      |  71.3%        64.8%        45.6%        77.6%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   3/10 (30%)   4/9 (44%)    4/9 (44%)  |  3/10 (30%)   0/10 (0%)    1/10 (10%)   3/10 (30%) |
|TERMINAL (d)           | 27/34 (79%)  28/35 (80%)  20/37 (54%)  24/32 (75%) | 22/33 (67%)  16/28 (57%)  16/42 (38%)  25/35 (71%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      456 (I)      353          358       |   452          561          455 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.088N     P=0.221N     P=0.010N**   P=0.285N   |  P=0.479      P=0.371N     P=0.022N*    P=0.218    |
|INCIDENTAL TUMOR       |  P=0.029N*    P=0.197N     P=0.005N**   P=0.122N   |  P=0.312      P=0.260N     P=0.069N     P=0.156    |
|LOGISTIC REGRESSION    |  P=0.045N*    P=0.209N     P=0.007N**   P=0.153N   |  P=0.312      P=0.194N     P=0.073N     P=0.152    |
|COCHRAN-ARMITAGE       |  P=0.035N*                                         |  P=0.245                                           |
|FISHER EXACT           |               P=0.211N     P=0.007N**   P=0.118N   |               P=0.179N     P=0.134N     P=0.136    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  20
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.0140%      0.0200%      0.0275%   |   VEHICLE      0.0140%      0.0200%      0.0275%   |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/60 (42%)  24/60 (40%)  19/60 (32%)  31/60 (52%) | 23/60 (38%)  25/60 (42%)  21/60 (35%)  19/60 (32%) |
|ADJUSTED (b)           |  50.7%        46.5%        40.5%        62.1%      |  54.1%        57.5%        47.6%        43.4%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   4/10 (40%)   0/9 (0%)     2/9 (22%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 11/34 (32%)   9/35 (26%)  10/37 (27%)  14/32 (44%) | 14/33 (42%)  11/28 (39%)  19/42 (45%)  11/35 (31%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      455 (I)      443          358       |   452          268          675          480       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292      P=0.488N     P=0.160N     P=0.172    |  P=0.131N     P=0.296      P=0.145N     P=0.245N   |
|INCIDENTAL TUMOR       |  P=0.299      P=0.509N     P=0.221N     P=0.227    |  P=0.244N     P=0.526      P=0.364N     P=0.248N   |
|LOGISTIC REGRESSION    |  P=0.172      P=0.496N     P=0.323N     P=0.178    |  P=0.181N     P=0.393      P=0.254N     P=0.276N   |
|COCHRAN-ARMITAGE       |  P=0.304                                           |  P=0.239N                                          |
|FISHER EXACT           |               P=0.500N     P=0.172N     P=0.180    |               P=0.426      P=0.425N     P=0.283N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/60 (82%)  50/60 (83%)  41/60 (68%)  52/60 (87%) | 38/60 (63%)  37/60 (62%)  32/60 (53%)  42/60 (70%) |
|ADJUSTED (b)           |  88.9%        90.8%        77.1%        96.3%      |  84.0%        83.4%        66.5%        83.7%      |
|INTERIM SACRIFICE 1 (c)|  7/10 (70%)   6/10 (60%)   4/9 (44%)    5/9 (56%)  |  3/10 (30%)   0/10 (0%)    1/10 (10%)   3/10 (30%) |
|TERMINAL (d)           | 28/34 (82%)  30/35 (86%)  25/37 (68%)  30/32 (94%) | 26/33 (79%)  21/28 (75%)  26/42 (62%)  27/35 (77%) |
|FIRST INCIDENCE (DAYS) |   455 (I)      455 (I)      353          358       |   452          268          455 (I)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.443      P=0.544      P=0.085N     P=0.228    |  P=0.341N     P=0.365      P=0.016N*    P=0.430    |
|INCIDENTAL TUMOR       |  P=0.540      P=0.517      P=0.071N     P=0.279    |  P=0.456      P=0.508N     P=0.061N     P=0.321    |
|LOGISTIC REGRESSION    |  P=0.487      P=0.495      P=0.070N     P=0.213    |  P=0.526      P=0.572N     P=0.061N     P=0.320    |
|COCHRAN-ARMITAGE       |  P=0.532N                                          |  P=0.421                                           |
|FISHER EXACT           |               P=0.500      P=0.070N     P=0.309    |               P=0.500N     P=0.177N     P=0.281    |
|=================================================================================================================================|
 
         DATE: 09/22/94                     EXPERIMENT: 05089 TEST: 02                                                 PAGE  21
                                 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CHLORAMINE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (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):   455
          Female interim sacrifices(days): 455
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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