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TR 391 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Microbiological Assoc.                          TRIS (2-CHLOROETHYL) PHOSPHATE                            DATE: 09/05/94       
EXPERIMENT: 05042 TEST: 02                                                                                     TIME: 16:37:58       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9565001          ROUTE: GAVAGE                                                                      NTP C#: 60128        
PATHOLOGIST: J. MOE                                                                                            CAS: 115-96-8        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Microbiological Assoc.                          TRIS (2-CHLOROETHYL) PHOSPHATE                            DATE: 09/05/94      
EXPERIMENT: 05042 TEST: 02                                                                                     TIME: 16:37:58      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9565001          ROUTE: GAVAGE                                                                      NTP C#: 60128       
PATHOLOGIST: J. MOE                                                                                            CAS: 115-96-8       
 
 
 
 
 
                                                    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: Microbiological Assoc.                          TRIS (2-CHLOROETHYL) PHOSPHATE                            DATE: 09/05/94       
EXPERIMENT: 05042 TEST: 02                                                                                     TIME: 16:37:58       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565001          ROUTE: GAVAGE                                                                      NTP C#: 60128        
PATHOLOGIST: J. MOE                                                                                            CAS: 115-96-8        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                 IN THE ANALYSIS OF THE STUDY OF TRIS (2-CHLOROETHYL) PHOSPHATE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Liver                         Hepatocellular Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Carcinoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Skin: Subcutaneous Tissue     Fibrosarcoma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   1
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/46 (0%)       0/23 (0%)       2/43 (5%)      |     0/49 (0%)       0/12 (0%)       1/48 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            8.7%          |      0.0%            0.0%            2.9%          |
|TERMINAL (d)           |     0/24 (0%)       0/0             2/23 (9%)      |     0/31 (0%)       0/0             1/34 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             729 (T)       |      ---             ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.135           (e)           P=0.228        |     P=0.325           (e)           P=0.518        |
|INCIDENTAL TUMOR       |     P=0.135           (e)           P=0.228        |     P=0.325           (e)           P=0.518        |
|LOGISTIC REGRESSION    |     P=0.135           (e)           P=0.228        |     P=0.325           (e)           P=0.518        |
|COCHRAN-ARMITAGE       |     P=0.107                                        |     P=0.294                                        |
|FISHER EXACT           |                       (e)           P=0.231        |                       (e)           P=0.495        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            4.4%          |
|TERMINAL (d)           |     0/25 (0%)       0/25 (0%)       0/25 (0%)      |     0/31 (0%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             482           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.112           (e)           P=0.278        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.122           (e)           P=0.263        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.081           (e)           P=0.199        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.095                                        |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   2
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      8/50 (16%)      5/50 (10%)     |     3/50 (6%)       7/50 (14%)      7/50 (14%)     |
|ADJUSTED (b)           |     20.6%           26.0%           18.2%          |      9.7%           18.1%           19.2%          |
|TERMINAL (d)           |     3/25 (12%)      4/25 (16%)      4/25 (16%)     |     3/31 (10%)      6/37 (16%)      6/35 (17%)     |
|FIRST INCIDENCE (DAYS) |      681             638             634           |      729 (T)         658             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.441N        P=0.369         P=0.493N       |     P=0.183         P=0.240         P=0.214        |
|INCIDENTAL TUMOR       |     P=0.450N        P=0.372         P=0.508N       |     P=0.195         P=0.253         P=0.227        |
|LOGISTIC REGRESSION    |     P=0.448N        P=0.372         P=0.508N       |     P=0.184         P=0.232         P=0.214        |
|COCHRAN-ARMITAGE       |     P=0.440N                                       |     P=0.135                                        |
|FISHER EXACT           |                     P=0.387         P=0.500N       |                     P=0.159         P=0.159        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      8/50 (16%)      6/50 (12%)     |     3/50 (6%)       8/50 (16%)      7/50 (14%)     |
|ADJUSTED (b)           |     20.6%           26.0%           20.8%          |      9.7%           20.8%           19.2%          |
|TERMINAL (d)           |     3/25 (12%)      4/25 (16%)      4/25 (16%)     |     3/31 (10%)      7/37 (19%)      6/35 (17%)     |
|FIRST INCIDENCE (DAYS) |      681             638             634           |      729 (T)         658             676           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.550N        P=0.369         P=0.603N       |     P=0.192         P=0.165         P=0.214        |
|INCIDENTAL TUMOR       |     P=0.543         P=0.372         P=0.604        |     P=0.204         P=0.175         P=0.227        |
|LOGISTIC REGRESSION    |     P=0.550         P=0.372         P=0.614        |     P=0.193         P=0.157         P=0.214        |
|COCHRAN-ARMITAGE       |     P=0.558                                        |     P=0.141                                        |
|FISHER EXACT           |                     P=0.387         P=0.620N       |                     P=0.100         P=0.159        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   3
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            4.0%            7.7%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/25 (0%)       1/25 (4%)       1/25 (4%)      |     0/31 (0%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             729 (T)         719           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.146         P=0.500         P=0.244        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.135         P=0.500         P=0.223        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.145         P=0.500         P=0.239        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.142                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.0%            0.0%            6.8%          |      0.0%            2.3%            0.0%          |
|TERMINAL (d)           |     1/25 (4%)       0/25 (0%)       1/25 (4%)      |     0/31 (0%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         ---             673           |      ---             666             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359         P=0.500N        P=0.497        |     P=0.713N        P=0.535           (e)          |
|INCIDENTAL TUMOR       |     P=0.348         P=0.500N        P=0.482        |     P=0.671N        P=0.567           (e)          |
|LOGISTIC REGRESSION    |     P=0.358         P=0.500N        P=0.496        |     P=0.726         P=0.488           (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.730                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.495           (e)          |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   4
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       4/50 (8%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.7%           12.5%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/25 (4%)       2/25 (8%)       0/25 (0%)      |     0/31 (0%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      670             623             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.236N        P=0.325         P=0.246N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.197N        P=0.360         P=0.257N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.225N        P=0.334         P=0.240N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.222N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.339         P=0.247N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/50 (40%)     18/50 (36%)     28/50 (56%)     |     3/50 (6%)       3/50 (6%)       5/50 (10%)     |
|ADJUSTED (b)           |     60.0%           53.5%           79.2%          |      9.7%            7.4%           13.7%          |
|TERMINAL (d)           |    12/25 (48%)     10/25 (40%)     18/25 (72%)     |     3/31 (10%)      2/37 (5%)       4/35 (11%)     |
|FIRST INCIDENCE (DAYS) |      636             623             571           |      729 (T)         626             696           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.087         P=0.460N        P=0.103        |     P=0.340         P=0.576N        P=0.426        |
|INCIDENTAL TUMOR       |     P=0.047 *       P=0.433N        P=0.056        |     P=0.330         P=0.569N        P=0.449        |
|LOGISTIC REGRESSION    |     P=0.045 *       P=0.450N        P=0.055        |     P=0.339         P=0.592N        P=0.430        |
|COCHRAN-ARMITAGE       |     P=0.065                                        |     P=0.283                                        |
|FISHER EXACT           |                     P=0.418N        P=0.080        |                     P=0.661N        P=0.357        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   5
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     10/50 (20%)     10/50 (20%)     |     2/50 (4%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |     26.2%           28.5%           27.8%          |      6.3%            4.5%            7.2%          |
|TERMINAL (d)           |     2/25 (8%)       4/25 (16%)      4/25 (16%)     |     1/31 (3%)       0/37 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      620             532             469           |      718             614             583           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.528         P=0.555         P=0.573        |     P=0.468         P=0.624N        P=0.561        |
|INCIDENTAL TUMOR       |     P=0.491N        P=0.553N        P=0.523N       |     P=0.456         P=0.563N        P=0.570        |
|LOGISTIC REGRESSION    |     P=0.510N        P=0.508N        P=0.556N       |     P=0.397         P=0.687N        P=0.521        |
|COCHRAN-ARMITAGE       |     P=0.550                                        |     P=0.406                                        |
|FISHER EXACT           |                     P=0.598N        P=0.598N       |                     P=0.691N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     10/50 (20%)     11/50 (22%)     |     2/50 (4%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |     26.2%           28.5%           29.6%          |      6.3%            4.5%            7.2%          |
|TERMINAL (d)           |     2/25 (8%)       4/25 (16%)      4/25 (16%)     |     1/31 (3%)       0/37 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      620             532             469           |      718             614             583           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.438         P=0.555         P=0.481        |     P=0.468         P=0.624N        P=0.561        |
|INCIDENTAL TUMOR       |     P=0.521         P=0.553N        P=0.601        |     P=0.456         P=0.563N        P=0.570        |
|LOGISTIC REGRESSION    |     P=0.495         P=0.508N        P=0.558        |     P=0.397         P=0.687N        P=0.521        |
|COCHRAN-ARMITAGE       |     P=0.451                                        |     P=0.406                                        |
|FISHER EXACT           |                     P=0.598N        P=0.500        |                     P=0.691N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   6
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/50 (52%)     27/50 (54%)     33/50 (66%)     |     5/50 (10%)      5/50 (10%)      8/50 (16%)     |
|ADJUSTED (b)           |     67.6%           68.3%           81.7%          |     15.6%           11.6%           20.2%          |
|TERMINAL (d)           |    13/25 (52%)     13/25 (52%)     18/25 (72%)     |     4/31 (13%)      2/37 (5%)       5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      620             532             469           |      718             614             583           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.149         P=0.454         P=0.168        |     P=0.300         P=0.511N        P=0.367        |
|INCIDENTAL TUMOR       |     P=0.086         P=0.522         P=0.107        |     P=0.277         P=0.463N        P=0.387        |
|LOGISTIC REGRESSION    |     P=0.073         P=0.488         P=0.087        |     P=0.257         P=0.562N        P=0.351        |
|COCHRAN-ARMITAGE       |     P=0.094                                        |     P=0.221                                        |
|FISHER EXACT           |                     P=0.500         P=0.111        |                     P=0.630N        P=0.277        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    26/50 (52%)     27/50 (54%)     33/50 (66%)     |     5/50 (10%)      5/50 (10%)      8/50 (16%)     |
|ADJUSTED (b)           |     67.6%           68.3%           81.7%          |     15.6%           11.6%           20.2%          |
|TERMINAL (d)           |    13/25 (52%)     13/25 (52%)     18/25 (72%)     |     4/31 (13%)      2/37 (5%)       5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      620             532             469           |      718             614             583           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.149         P=0.454         P=0.168        |     P=0.300         P=0.511N        P=0.367        |
|INCIDENTAL TUMOR       |     P=0.086         P=0.522         P=0.107        |     P=0.277         P=0.463N        P=0.387        |
|LOGISTIC REGRESSION    |     P=0.073         P=0.488         P=0.087        |     P=0.257         P=0.562N        P=0.351        |
|COCHRAN-ARMITAGE       |     P=0.094                                        |     P=0.221                                        |
|FISHER EXACT           |                     P=0.500         P=0.111        |                     P=0.630N        P=0.277        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   7
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)     11/50 (22%)      9/50 (18%)     |     2/50 (4%)       2/50 (4%)       5/49 (10%)     |
|ADJUSTED (b)           |     28.0%           39.7%           30.0%          |      5.3%            5.4%           14.3%          |
|TERMINAL (d)           |     7/25 (28%)      9/25 (36%)      6/25 (24%)     |     0/31 (0%)       2/37 (5%)       5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      729 (T)         655             571           |      632             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.345         P=0.197         P=0.393        |     P=0.181         P=0.631N        P=0.273        |
|INCIDENTAL TUMOR       |     P=0.333         P=0.197         P=0.391        |     P=0.171         P=0.590N        P=0.258        |
|LOGISTIC REGRESSION    |     P=0.336         P=0.182         P=0.381        |     P=0.172         P=0.675N        P=0.254        |
|COCHRAN-ARMITAGE       |     P=0.348                                        |     P=0.140                                        |
|FISHER EXACT           |                     P=0.218         P=0.393        |                     P=0.691N        P=0.210        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     10.2%            2.4%            6.3%          |      3.2%            0.0%            0.0%          |
|TERMINAL (d)           |     2/25 (8%)       0/25 (0%)       1/25 (4%)      |     1/31 (3%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      636             626             604           |      729 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.417N        P=0.316N        P=0.516N       |     P=0.250N        P=0.465N        P=0.476N       |
|INCIDENTAL TUMOR       |     P=0.332N        P=0.271N        P=0.439N       |     P=0.250N        P=0.465N        P=0.476N       |
|LOGISTIC REGRESSION    |     P=0.402N        P=0.306N        P=0.504N       |     P=0.250N        P=0.465N        P=0.476N       |
|COCHRAN-ARMITAGE       |     P=0.399N                                       |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.309N        P=0.500N       |                     P=0.500N        P=0.505N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   8
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     12/50 (24%)     10/50 (20%)     |     3/50 (6%)       2/50 (4%)       5/49 (10%)     |
|ADJUSTED (b)           |     37.6%           41.1%           31.7%          |      8.4%            5.4%           14.3%          |
|TERMINAL (d)           |     9/25 (36%)      9/25 (36%)      6/25 (24%)     |     1/31 (3%)       2/37 (5%)       5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      636             626             571           |      632             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.542         P=0.388         P=0.594        |     P=0.327         P=0.424N        P=0.428        |
|INCIDENTAL TUMOR       |     P=0.526N        P=0.410         P=0.567N       |     P=0.317         P=0.386N        P=0.412        |
|LOGISTIC REGRESSION    |     P=0.537         P=0.368         P=0.589        |     P=0.319         P=0.455N        P=0.413        |
|COCHRAN-ARMITAGE       |     P=0.549N                                       |     P=0.265                                        |
|FISHER EXACT           |                     P=0.405         P=0.598N       |                     P=0.500N        P=0.346        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            0.0%            8.2%          |
|TERMINAL (d)           |     0/25 (0%)       0/25 (0%)       0/25 (0%)      |     0/31 (0%)       0/37 (0%)       2/35 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             ---             698           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.043 *         (e)           P=0.145        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.048 *         (e)           P=0.167        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.042 *         (e)           P=0.144        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.037 *                                      |
|FISHER EXACT           |                       (e)             (e)          |                       (e)           P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE   9
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       3/50 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      3.2%            0.0%            8.2%          |
|TERMINAL (d)           |     0/25 (0%)       0/25 (0%)       0/25 (0%)      |     1/31 (3%)       0/37 (0%)       2/35 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      729 (T)         ---             698           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.199         P=0.465N        P=0.350        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.215         P=0.465N        P=0.382        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.200         P=0.465N        P=0.353        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.176                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500N        P=0.309        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/45 (0%)       0/22 (0%)       0/48 (0%)      |     4/48 (8%)       3/14 (21%)      1/44 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     12.6%          100.0%            3.0%          |
|TERMINAL (d)           |     0/24 (0%)       0/0             0/25 (0%)      |     3/29 (10%)      3/3 (100%)      1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      544             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.125N        P=0.046 *       P=0.145N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.169N        P=0.002 **      P=0.197N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.141N        P=0.150         P=0.177N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.193N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.184         P=0.209N       |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  10
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       3/50 (6%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%           10.0%            4.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/25 (0%)       2/25 (8%)       1/25 (4%)      |     0/31 (0%)       0/37 (0%)       0/35 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             480             729 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.378         P=0.124         P=0.500        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.376         P=0.146         P=0.500        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.377         P=0.121         P=0.500        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.378                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.121         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       4/50 (8%)       3/50 (6%)      |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      4.0%           11.0%            7.6%          |      0.0%            2.1%            7.6%          |
|TERMINAL (d)           |     1/25 (4%)       0/25 (0%)       0/25 (0%)      |     0/31 (0%)       0/37 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         626             627           |      ---             622             627           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.252         P=0.176         P=0.300        |     P=0.073         P=0.547         P=0.148        |
|INCIDENTAL TUMOR       |     P=0.267         P=0.177         P=0.351        |     P=0.043 *       P=0.557         P=0.131        |
|LOGISTIC REGRESSION    |     P=0.159         P=0.179         P=0.303        |     P=0.057         P=0.450         P=0.128        |
|COCHRAN-ARMITAGE       |     P=0.252                                        |     P=0.060                                        |
|FISHER EXACT           |                     P=0.181         P=0.309        |                     P=0.500         P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  11
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       7/50 (14%)      4/50 (8%)      |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      8.0%           19.9%           11.3%          |      0.0%            2.1%            7.6%          |
|TERMINAL (d)           |     2/25 (8%)       2/25 (8%)       1/25 (4%)      |     0/31 (0%)       0/37 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         480             627           |      ---             622             627           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.298         P=0.084         P=0.333        |     P=0.073         P=0.547         P=0.148        |
|INCIDENTAL TUMOR       |     P=0.313         P=0.095         P=0.377        |     P=0.043 *       P=0.557         P=0.131        |
|LOGISTIC REGRESSION    |     P=0.294         P=0.081         P=0.332        |     P=0.057         P=0.450         P=0.128        |
|COCHRAN-ARMITAGE       |     P=0.297                                        |     P=0.060                                        |
|FISHER EXACT           |                     P=0.080         P=0.339        |                     P=0.500         P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       4/50 (8%)       3/50 (6%)      |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |      8.0%           11.0%            7.6%          |      0.0%            2.1%            7.6%          |
|TERMINAL (d)           |     2/25 (8%)       0/25 (0%)       0/25 (0%)      |     0/31 (0%)       0/37 (0%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      729 (T)         626             627           |      ---             622             627           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.411         P=0.329         P=0.491        |     P=0.073         P=0.547         P=0.148        |
|INCIDENTAL TUMOR       |     P=0.437         P=0.335         P=0.547        |     P=0.043 *       P=0.557         P=0.131        |
|LOGISTIC REGRESSION    |     P=0.414         P=0.335         P=0.497        |     P=0.057         P=0.450         P=0.128        |
|COCHRAN-ARMITAGE       |     P=0.417                                        |     P=0.060                                        |
|FISHER EXACT           |                     P=0.339         P=0.500        |                     P=0.500         P=0.121        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  12
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/28 (4%)       0/49 (0%)      |     0/50 (0%)       1/20 (5%)       0/48 (0%)      |
|ADJUSTED (b)           |      7.9%            3.7%            0.0%          |      0.0%           12.5%            0.0%          |
|TERMINAL (d)           |     0/25 (0%)       0/3 (0%)        0/24 (0%)      |     0/31 (0%)       1/8 (13%)       0/34 (0%)      |
|FIRST INCIDENCE (DAYS) |      632             712             ---           |      ---             729 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.066N        P=0.331N        P=0.130N       |     P=0.687N        P=0.233           (e)          |
|INCIDENTAL TUMOR       |     P=0.062N        P=0.307N        P=0.118N       |     P=0.687N        P=0.233           (e)          |
|LOGISTIC REGRESSION    |     P=0.081N        P=0.578N        P=0.124N       |     P=0.687N        P=0.233           (e)          |
|COCHRAN-ARMITAGE       |     P=0.078N                                       |     P=0.703                                        |
|FISHER EXACT           |                     P=0.546N        P=0.125N       |                     P=0.286           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/24 (0%)       0/50 (0%)      |                                                    |
|ADJUSTED (b)           |      7.3%            0.0%            0.0%          |                                                    |
|TERMINAL (d)           |     1/25 (4%)       0/0             0/25 (0%)      |                                                    |
|FIRST INCIDENCE (DAYS) |      694             ---             ---           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.120N        P=0.507N        P=0.232N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.131N        P=0.515N        P=0.257N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.129N        P=0.659N        P=0.239N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.117N                                       |                                                    |
|FISHER EXACT           |                     P=0.454N        P=0.247N       |                                                    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  13
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |                                                    |      0.0%            2.7%            7.6%          |
|TERMINAL (d)           |                                                    |     0/31 (0%)       1/37 (3%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             729 (T)         519           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.072         P=0.535         P=0.148        |
|INCIDENTAL TUMOR       |                                                    |     P=0.078         P=0.535         P=0.144        |
|LOGISTIC REGRESSION    |                                                    |     P=0.057         P=0.535         P=0.113        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.060                                        |
|FISHER EXACT           |                                                    |                     P=0.500         P=0.121        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      5/50 (10%)      0/50 (0%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     17.6%           15.7%            0.0%          |      0.0%            5.4%            2.9%          |
|TERMINAL (d)           |     2/25 (8%)       2/25 (8%)       0/25 (0%)      |     0/31 (0%)       2/37 (5%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      632             623             ---           |      ---             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.023N*       P=0.528N        P=0.022N*      |     P=0.390         P=0.278         P=0.524        |
|INCIDENTAL TUMOR       |     P=0.015N*       P=0.484N        P=0.019N*      |     P=0.390         P=0.278         P=0.524        |
|LOGISTIC REGRESSION    |     P=0.018N*       P=0.503N        P=0.018N*      |     P=0.390         P=0.278         P=0.524        |
|COCHRAN-ARMITAGE       |     P=0.017N*                                      |     P=0.360                                        |
|FISHER EXACT           |                     P=0.500N        P=0.013N*      |                     P=0.247         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  14
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      6/50 (12%)      0/50 (0%)      |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |     17.6%           19.4%            0.0%          |      0.0%            5.4%            2.9%          |
|TERMINAL (d)           |     2/25 (8%)       3/25 (12%)      0/25 (0%)      |     0/31 (0%)       2/37 (5%)       1/35 (3%)      |
|FIRST INCIDENCE (DAYS) |      632             623             ---           |      ---             729 (T)         729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.027N*       P=0.590         P=0.022N*      |     P=0.390         P=0.278         P=0.524        |
|INCIDENTAL TUMOR       |     P=0.019N*       P=0.606N        P=0.019N*      |     P=0.390         P=0.278         P=0.524        |
|LOGISTIC REGRESSION    |     P=0.022N*       P=0.618         P=0.018N*      |     P=0.390         P=0.278         P=0.524        |
|COCHRAN-ARMITAGE       |     P=0.021N*                                      |     P=0.360                                        |
|FISHER EXACT           |                     P=0.620N        P=0.013N*      |                     P=0.247         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      3.8%            0.0%            0.0%          |      3.2%            0.0%            5.7%          |
|TERMINAL (d)           |     0/25 (0%)       0/25 (0%)       0/25 (0%)      |     1/31 (3%)       0/37 (0%)       2/35 (6%)      |
|FIRST INCIDENCE (DAYS) |      715             ---             ---           |      729 (T)         ---             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.266N        P=0.500N        P=0.492N       |     P=0.390         P=0.465N        P=0.543        |
|INCIDENTAL TUMOR       |     P=0.291N        P=0.515N        P=0.531N       |     P=0.390         P=0.465N        P=0.543        |
|LOGISTIC REGRESSION    |     P=0.271N        P=0.506N        P=0.501N       |     P=0.390         P=0.465N        P=0.543        |
|COCHRAN-ARMITAGE       |     P=0.269N                                       |     P=0.360                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  15
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       1/50 (2%)      |    11/50 (22%)      7/50 (14%)      5/50 (10%)     |
|ADJUSTED (b)           |     16.4%            9.0%            2.7%          |     28.7%           16.2%           14.3%          |
|TERMINAL (d)           |     1/25 (4%)       1/25 (4%)       0/25 (0%)      |     5/31 (16%)      2/37 (5%)       5/35 (14%)     |
|FIRST INCIDENCE (DAYS) |      654             532             666           |      537             654             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.076N        P=0.378N        P=0.107N       |     P=0.042N*       P=0.136N        P=0.059N       |
|INCIDENTAL TUMOR       |     P=0.084N        P=0.352N        P=0.125N       |     P=0.030N*       P=0.086N        P=0.067N       |
|LOGISTIC REGRESSION    |     P=0.071N        P=0.358N        P=0.105N       |     P=0.031N*       P=0.050N        P=0.062N       |
|COCHRAN-ARMITAGE       |     P=0.070N                                       |     P=0.063N                                       |
|FISHER EXACT           |                     P=0.357N        P=0.102N       |                     P=0.218N        P=0.086N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       3/50 (6%)       1/50 (2%)      |    10/50 (20%)      7/50 (14%)      3/50 (6%)      |
|ADJUSTED (b)           |     13.0%            9.0%            2.7%          |     26.0%           16.2%            8.6%          |
|TERMINAL (d)           |     1/25 (4%)       1/25 (4%)       0/25 (0%)      |     4/31 (13%)      2/37 (5%)       3/35 (9%)      |
|FIRST INCIDENCE (DAYS) |      654             532             666           |      537             654             729 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.140N        P=0.518N        P=0.183N       |     P=0.018N*       P=0.196N        P=0.027N*      |
|INCIDENTAL TUMOR       |     P=0.154N        P=0.492N        P=0.212N       |     P=0.011N*       P=0.138N        P=0.028N*      |
|LOGISTIC REGRESSION    |     P=0.134N        P=0.501N        P=0.182N       |     P=0.011N*       P=0.084N        P=0.029N*      |
|COCHRAN-ARMITAGE       |     P=0.133N                                       |     P=0.028N*                                      |
|FISHER EXACT           |                     P=0.500N        P=0.181N       |                     P=0.298N        P=0.036N*      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  16
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    28/50 (56%)     28/50 (56%)     32/50 (64%)     |    14/50 (28%)     16/50 (32%)     19/50 (38%)     |
|ADJUSTED (b)           |     79.8%           79.4%           88.4%          |     40.5%           39.4%           48.3%          |
|TERMINAL (d)           |    18/25 (72%)     18/25 (72%)     21/25 (84%)     |    11/31 (35%)     13/37 (35%)     15/35 (43%)     |
|FIRST INCIDENCE (DAYS) |      636             480             571           |      544             626             519           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.263         P=0.533         P=0.295        |     P=0.296         P=0.528N        P=0.343        |
|INCIDENTAL TUMOR       |     P=0.187         P=0.577         P=0.213        |     P=0.287         P=0.581N        P=0.339        |
|LOGISTIC REGRESSION    |     P=0.176         P=0.531         P=0.196        |     P=0.273         P=0.572N        P=0.320        |
|COCHRAN-ARMITAGE       |     P=0.239                                        |     P=0.169                                        |
|FISHER EXACT           |                     P=0.580N        P=0.270        |                     P=0.414         P=0.198        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    22/50 (44%)     21/50 (42%)     21/50 (42%)     |    14/50 (28%)     15/50 (30%)     20/50 (40%)     |
|ADJUSTED (b)           |     54.2%           50.2%           49.6%          |     35.1%           32.1%           44.7%          |
|TERMINAL (d)           |     7/25 (28%)      6/25 (24%)      6/25 (24%)     |     6/31 (19%)      6/37 (16%)     11/35 (31%)     |
|FIRST INCIDENCE (DAYS) |      620             532             469           |      397             614             482           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.483N        P=0.548N        P=0.509N       |     P=0.261         P=0.457N        P=0.302        |
|INCIDENTAL TUMOR       |     P=0.396N        P=0.462N        P=0.451N       |     P=0.173         P=0.501N        P=0.203        |
|LOGISTIC REGRESSION    |     P=0.439N        P=0.397N        P=0.486N       |     P=0.186         P=0.591N        P=0.231        |
|COCHRAN-ARMITAGE       |     P=0.460N                                       |     P=0.120                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500         P=0.146        |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05042 TEST: 02                                                 PAGE  17
                       STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIS (2-CHLOROETHYL) PHOSPHATE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      CONTROL         175MG/KG        350MG/KG      |      CONTROL         175MG/KG        350MG/KG      |
|                       |      MALE            LOW MALE        HIGHMALE      |      FEMALE          LOW FEM         HIGHFEM       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    38/50 (76%)     39/50 (78%)     42/50 (84%)     |    25/50 (50%)     26/50 (52%)     37/50 (74%)     |
|ADJUSTED (b)           |     90.4%           88.4%           93.2%          |     60.7%           56.2%           78.6%          |
|TERMINAL (d)           |    21/25 (84%)     20/25 (80%)     22/25 (88%)     |    15/31 (48%)     17/37 (46%)     25/35 (71%)     |
|FIRST INCIDENCE (DAYS) |      620             480             469           |      397             614             482           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.288         P=0.442         P=0.317        |     P=0.096         P=0.339N        P=0.124        |
|INCIDENTAL TUMOR       |     P=0.153         P=0.547         P=0.175        |     P=0.034 *       P=0.413N        P=0.042 *      |
|LOGISTIC REGRESSION    |     P=0.155         P=0.497         P=0.150        |     P=0.036 *       P=0.429N        P=0.047 *      |
|COCHRAN-ARMITAGE       |     P=0.194                                        |     P=0.010 **                                     |
|FISHER EXACT           |                     P=0.500         P=0.227        |                     P=0.500         P=0.011 *      |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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