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TDMS Study 05035-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                4-HYDROXYACETANILIDE                                 DATE: 09/04/94       
EXPERIMENT: 05035 TEST: 02                                                                                     TIME: 22:38:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9561902          ROUTE: DOSED FEED                                                                  NTP C#: 55801        
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 103-90-2        
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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: Mason                                                4-HYDROXYACETANILIDE                                 DATE: 09/04/94      
EXPERIMENT: 05035 TEST: 02                                                                                     TIME: 22:38:30      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9561902          ROUTE: DOSED FEED                                                                  NTP C#: 55801       
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 103-90-2       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                4-HYDROXYACETANILIDE                                 DATE: 09/04/94       
EXPERIMENT: 05035 TEST: 02                                                                                     TIME: 22:38:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9561902          ROUTE: DOSED FEED                                                                  NTP C#: 55801        
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                                                         CAS: 103-90-2        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF 4-HYDROXYACETANILIDE
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skin: Subcutaneous Tissue     Fibrosarcoma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/47 (0%)    4/48 (8%)    1/48 (2%)    1/48 (2%)  |  0/46 (0%)    0/46 (0%)    0/45 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%         9.9%         2.5%         3.4%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/31 (0%)    3/39 (8%)    0/30 (0%)    1/29 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          671          657          729 (T)   |  0/24 (0%)    0/32 (0%)    0/22 (0%)    0/37 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.455N     P=0.095      P=0.521      P=0.487    |                                                    |
|INCIDENTAL TUMOR       |  P=0.365N     P=0.054      P=0.674      P=0.487    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.404N     P=0.073      P=0.492      P=0.487    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.391N                                          |    (e)          (e)          (e)          (e)      |
|FISHER EXACT           |               P=0.061      P=0.505      P=0.505    |    (e)                                             |
                                                                                               (e)          (e)          (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/47 (0%)    5/48 (10%)   1/48 (2%)    1/48 (2%)  |  1/46 (2%)    0/46 (0%)    0/45 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%        12.4%         2.5%         3.4%      |   4.2%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/31 (0%)    4/39 (10%)   0/30 (0%)    1/29 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          671          657          729 (T)   |  1/24 (4%)    0/32 (0%)    0/22 (0%)    0/37 (0%)  |
|-----------------------|                                                    |   730 (T)      ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.354N     P=0.056      P=0.521      P=0.487    |                                                    |
|INCIDENTAL TUMOR       |  P=0.275N     P=0.032 *    P=0.674      P=0.487    |  P=0.320N     P=0.443N     P=0.517N     P=0.414N   |
|LOGISTIC REGRESSION    |  P=0.303N     P=0.041 *    P=0.492      P=0.487    |  P=0.320N     P=0.443N     P=0.517N     P=0.414N   |
|COCHRAN-ARMITAGE       |  P=0.290N                                          |  P=0.320N     P=0.443N     P=0.517N     P=0.414N   |
|FISHER EXACT           |               P=0.030 *    P=0.505      P=0.505    |  P=0.347N                                          |
                                                                                             P=0.500N     P=0.505N     P=0.489N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    3/50 (6%)    3/50 (6%)  |  4/50 (8%)    2/50 (4%)    1/50 (2%)    2/51 (4%)  |
|ADJUSTED (b)           |  12.0%         5.0%         9.1%         8.6%      |  12.2%         6.3%         4.0%         5.3%      |
|TERMINAL (d)           |  3/32 (9%)    2/40 (5%)    1/31 (3%)    2/31 (6%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   703          729 (T)      709          523       |  1/27 (4%)    2/32 (6%)    1/25 (4%)    2/38 (5%)  |
|-----------------------|                                                    |   635          730 (T)      730 (T)      730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539      P=0.246N     P=0.514N     P=0.514N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.561N     P=0.311N     P=0.369N     P=0.524N   |  P=0.218N     P=0.295N     P=0.215N     P=0.235N   |
|LOGISTIC REGRESSION    |  P=0.564N     P=0.275N     P=0.440N     P=0.511N   |  P=0.317N     P=0.355N     P=0.219N     P=0.512N   |
|COCHRAN-ARMITAGE       |  P=0.545N                                          |  P=0.260N     P=0.325N     P=0.212N     P=0.301N   |
|FISHER EXACT           |               P=0.339N     P=0.500N     P=0.500N   |  P=0.279N                                          |
                                                                                             P=0.339N     P=0.181N     P=0.329N 
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    3/50 (6%)    3/50 (6%)  |  5/50 (10%)   2/50 (4%)    2/50 (4%)    2/51 (4%)  |
|ADJUSTED (b)           |  12.0%         5.0%         9.1%         8.6%      |  14.3%         6.3%         7.1%         5.3%      |
|TERMINAL (d)           |  3/32 (9%)    2/40 (5%)    1/31 (3%)    2/31 (6%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   703          729 (T)      709          523       |  1/27 (4%)    2/32 (6%)    1/25 (4%)    2/38 (5%)  |
|-----------------------|                                                    |   611          730 (T)      684          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539      P=0.246N     P=0.514N     P=0.514N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.561N     P=0.311N     P=0.369N     P=0.524N   |  P=0.173N     P=0.188N     P=0.270N     P=0.144N   |
|LOGISTIC REGRESSION    |  P=0.564N     P=0.275N     P=0.440N     P=0.511N   |  P=0.294N     P=0.215N     P=0.265N     P=0.331N   |
|COCHRAN-ARMITAGE       |  P=0.545N                                          |  P=0.214N     P=0.211N     P=0.252N     P=0.200N   |
|FISHER EXACT           |               P=0.339N     P=0.500N     P=0.500N   |  P=0.220N                                          |
                                                                                             P=0.218N     P=0.218N     P=0.210N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   3.1%         2.5%         6.5%         0.0%      |   3.7%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/32 (3%)    1/40 (3%)    2/31 (6%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      ---       |  1/27 (4%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   730 (T)      ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.419N     P=0.711N     P=0.489      P=0.506N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.419N     P=0.711N     P=0.489      P=0.506N   |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.419N     P=0.711N     P=0.489      P=0.506N   |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.374N                                          |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|FISHER EXACT           |               P=0.753N     P=0.500      P=0.500N   |  P=0.349N                                          |
                                                                                             P=0.500N     P=0.500N     P=0.495N 
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   0.0%         2.5%         6.5%         0.0%      |   3.7%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/32 (0%)    1/40 (3%)    2/31 (6%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |  1/27 (4%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   730 (T)      ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.629N     P=0.545      P=0.231        (e)      |                                                    |
|INCIDENTAL TUMOR       |  P=0.629N     P=0.545      P=0.231        (e)      |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|LOGISTIC REGRESSION    |  P=0.629N     P=0.545      P=0.231        (e)      |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|COCHRAN-ARMITAGE       |  P=0.588N                                          |  P=0.323N     P=0.466N     P=0.515N     P=0.432N   |
|FISHER EXACT           |               P=0.500      P=0.247        (e)      |  P=0.349N                                          |
                                                                                             P=0.500N     P=0.500N     P=0.495N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    2/50 (4%)    1/50 (2%)  |  0/49 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.3%         2.5%         5.0%         2.4%      |   0.0%         0.0%         3.8%         0.0%      |
|TERMINAL (d)           |  1/32 (3%)    1/40 (3%)    0/31 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   541          729 (T)      650          570       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          726          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.511N     P=0.451N     P=0.677N     P=0.509N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.399N     P=0.482N     P=0.614N     P=0.478N   |  P=0.675        (e)        P=0.485        (e)      |
|LOGISTIC REGRESSION    |  P=0.476N     P=0.500N     P=0.668      P=0.487N   |  P=0.475        (e)        P=0.477        (e)      |
|COCHRAN-ARMITAGE       |  P=0.479N                                          |  P=0.666        (e)        P=0.483        (e)      |
|FISHER EXACT           |               P=0.500N     P=0.691N     P=0.500N   |  P=0.651                                           |
                                                                                               (e)        P=0.505        (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 11/50 (22%)   8/50 (16%)   5/50 (10%)   4/50 (8%)  |  3/49 (6%)    4/50 (8%)    7/50 (14%)   2/50 (4%)  |
|ADJUSTED (b)           |  29.4%        19.4%        14.7%        11.7%      |  11.1%        11.9%        22.3%         5.3%      |
|TERMINAL (d)           |  7/32 (22%)   7/40 (18%)   4/31 (13%)   3/31 (10%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   479          502          512          512       |  3/27 (11%)   3/32 (9%)    3/25 (12%)   2/38 (5%)  |
|-----------------------|                                                    |   730 (T)      667          549          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.052N     P=0.180N     P=0.092N     P=0.059N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.035N*    P=0.349N     P=0.087N     P=0.054N   |  P=0.318N     P=0.584      P=0.132      P=0.346N   |
|LOGISTIC REGRESSION    |  P=0.030N*    P=0.297N     P=0.079N     P=0.049N*  |  P=0.493N     P=0.549      P=0.128      P=0.346N   |
|COCHRAN-ARMITAGE       |  P=0.029N*                                         |  P=0.396N     P=0.535      P=0.127      P=0.346N   |
|FISHER EXACT           |               P=0.306N     P=0.086N     P=0.045N*  |  P=0.426N                                          |
                                                                                             P=0.511      P=0.167      P=0.490N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   1/50 (2%)    6/50 (12%)   3/50 (6%)  |  0/49 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  17.6%         2.5%        15.6%         8.7%      |   0.0%         0.0%         0.0%         2.2%      |
|TERMINAL (d)           |  2/32 (6%)    1/40 (3%)    2/31 (6%)    1/31 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   563          729 (T)      647          637       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.452N     P=0.024N*    P=0.465N     P=0.182N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.210N     P=0.232N     P=0.338N     P=0.129N   |  P=0.195        (e)          (e)        P=0.514    |
|LOGISTIC REGRESSION    |  P=0.231N     P=0.153N     P=0.264N     P=0.145N   |  P=0.189        (e)          (e)        P=0.527    |
|COCHRAN-ARMITAGE       |  P=0.386N                                          |  P=0.176        (e)          (e)        P=0.436    |
|FISHER EXACT           |               P=0.030N*    P=0.500N     P=0.159N   |  P=0.188                                           |
                                                                                               (e)          (e)        P=0.505  
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)   9/50 (18%)  10/50 (20%)   7/50 (14%) |  3/49 (6%)    4/50 (8%)    7/50 (14%)   3/50 (6%)  |
|ADJUSTED (b)           |  39.8%        21.8%        25.9%        19.7%      |  11.1%        11.9%        22.3%         7.4%      |
|TERMINAL (d)           |  9/32 (28%)   8/40 (20%)   5/31 (16%)   4/31 (13%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   479          502          512          512       |  3/27 (11%)   3/32 (9%)    3/25 (12%)   2/38 (5%)  |
|-----------------------|                                                    |   730 (T)      667          549          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.108N     P=0.038N*    P=0.136N     P=0.046N*  |                                                    |
|INCIDENTAL TUMOR       |  P=0.036N*    P=0.202N     P=0.079N     P=0.030N*  |  P=0.461N     P=0.584      P=0.132      P=0.520N   |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.080N     P=0.057N     P=0.031N*  |  P=0.480      P=0.549      P=0.128      P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.054N                                          |  P=0.558N     P=0.535      P=0.127      P=0.620N   |
|FISHER EXACT           |               P=0.083N     P=0.127N     P=0.028N*  |  P=0.547                                           |
                                                                                             P=0.511      P=0.167      P=0.651N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/50 (32%)   9/50 (18%)  10/50 (20%)   7/50 (14%) |  3/49 (6%)    4/50 (8%)    7/50 (14%)   3/50 (6%)  |
|ADJUSTED (b)           |  39.8%        21.8%        25.9%        19.7%      |  11.1%        11.9%        22.3%         7.4%      |
|TERMINAL (d)           |  9/32 (28%)   8/40 (20%)   5/31 (16%)   4/31 (13%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   479          502          512          512       |  3/27 (11%)   3/32 (9%)    3/25 (12%)   2/38 (5%)  |
|-----------------------|                                                    |   730 (T)      667          549          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.108N     P=0.038N*    P=0.136N     P=0.046N*  |                                                    |
|INCIDENTAL TUMOR       |  P=0.036N*    P=0.202N     P=0.079N     P=0.030N*  |  P=0.461N     P=0.584      P=0.132      P=0.520N   |
|LOGISTIC REGRESSION    |  P=0.031N*    P=0.080N     P=0.057N     P=0.031N*  |  P=0.480      P=0.549      P=0.128      P=0.515N   |
|COCHRAN-ARMITAGE       |  P=0.054N                                          |  P=0.558N     P=0.535      P=0.127      P=0.620N   |
|FISHER EXACT           |               P=0.083N     P=0.127N     P=0.028N*  |  P=0.547                                           |
                                                                                             P=0.511      P=0.167      P=0.651N 
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   6/50 (12%)   5/50 (10%)  10/50 (20%) |  1/50 (2%)    4/50 (8%)    4/50 (8%)    4/51 (8%)  |
|ADJUSTED (b)           |  24.2%        15.0%        15.0%        29.8%      |   3.7%        10.9%        14.7%        10.5%      |
|TERMINAL (d)           |  7/32 (22%)   6/40 (15%)   3/31 (10%)   8/31 (26%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   718          729 (T)      687          563       |  1/27 (4%)    2/32 (6%)    3/25 (12%)   4/38 (11%) |
|-----------------------|                                                    |   730 (T)      638          659          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.166      P=0.228N     P=0.299N     P=0.368    |                                                    |
|INCIDENTAL TUMOR       |  P=0.215      P=0.273N     P=0.204N     P=0.368    |  P=0.353      P=0.217      P=0.158      P=0.294    |
|LOGISTIC REGRESSION    |  P=0.208      P=0.248N     P=0.256N     P=0.378    |  P=0.303      P=0.245      P=0.149      P=0.294    |
|COCHRAN-ARMITAGE       |  P=0.262                                           |  P=0.277      P=0.182      P=0.145      P=0.294    |
|FISHER EXACT           |               P=0.387N     P=0.277N     P=0.398    |  P=0.254                                           |
                                                                                             P=0.181      P=0.181      P=0.187  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   0.0%         2.4%         0.0%         5.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/32 (0%)    0/40 (0%)    0/31 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          671          ---          632       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156      P=0.531        (e)        P=0.240    |                                                    |
|INCIDENTAL TUMOR       |  P=0.257      P=0.331        (e)        P=0.246    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.169      P=0.500        (e)        P=0.237    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.168                                           |    (e)          (e)          (e)          (e)      |
|FISHER EXACT           |               P=0.500        (e)        P=0.247    |    (e)                                             |
                                                                                               (e)          (e)          (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   7/50 (14%)   5/50 (10%)  12/50 (24%) |  1/50 (2%)    4/50 (8%)    4/50 (8%)    4/51 (8%)  |
|ADJUSTED (b)           |  24.2%        17.0%        15.0%        33.6%      |   3.7%        10.9%        14.7%        10.5%      |
|TERMINAL (d)           |  7/32 (22%)   6/40 (15%)   3/31 (10%)   8/31 (26%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   718          671          687          563       |  1/27 (4%)    2/32 (6%)    3/25 (12%)   4/38 (11%) |
|-----------------------|                                                    |   730 (T)      638          659          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.085      P=0.325N     P=0.299N     P=0.210    |                                                    |
|INCIDENTAL TUMOR       |  P=0.137      P=0.427N     P=0.204N     P=0.207    |  P=0.353      P=0.217      P=0.158      P=0.294    |
|LOGISTIC REGRESSION    |  P=0.115      P=0.391N     P=0.256N     P=0.206    |  P=0.303      P=0.245      P=0.149      P=0.294    |
|COCHRAN-ARMITAGE       |  P=0.146                                           |  P=0.277      P=0.182      P=0.145      P=0.294    |
|FISHER EXACT           |               P=0.500N     P=0.277N     P=0.227    |  P=0.254                                           |
                                                                                             P=0.181      P=0.181      P=0.187  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/47 (0%)    2/49 (4%)    1/49 (2%)    0/51 (0%)  |
|ADJUSTED (b)           |                                                    |   0.0%         6.3%         3.8%         0.0%      |
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |                                                    |  0/25 (0%)    2/32 (6%)    0/24 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          730 (T)      726          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |                                                    |
|INCIDENTAL TUMOR       |                                                    |  P=0.297N     P=0.294      P=0.485        (e)      |
|LOGISTIC REGRESSION    |                                                    |  P=0.392N     P=0.294      P=0.477        (e)      |
|COCHRAN-ARMITAGE       |                                                    |  P=0.305N     P=0.294      P=0.489        (e)      |
|FISHER EXACT           |                                                    |  P=0.340N                                          |
                                                                                             P=0.258      P=0.510        (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    0/39 (0%)    0/39 (0%)    0/46 (0%)  | 14/46 (30%)  16/43 (37%)   7/42 (17%)  14/46 (30%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  42.7%        48.8%        27.7%        39.3%      |
|TERMINAL (d)           |  0/31 (0%)    0/34 (0%)    0/24 (0%)    0/27 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |  8/25 (32%)  12/28 (43%)   4/19 (21%)  12/33 (36%) |
|-----------------------|                                                    |   536          634          534          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |                                                    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.183N     P=0.531      P=0.181N     P=0.317N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.348N     P=0.351      P=0.172N     P=0.554N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.301N     P=0.342      P=0.179N     P=0.553N   |
|FISHER EXACT           |                 (e)          (e)          (e)      |  P=0.310N                                          |
                                                                                             P=0.326      P=0.103N     P=0.589N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/48 (0%)    0/39 (0%)    0/39 (0%)    0/46 (0%)  | 15/46 (33%)  17/43 (40%)   8/42 (19%)  14/46 (30%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  46.1%        49.9%        30.0%        39.3%      |
|TERMINAL (d)           |  0/31 (0%)    0/34 (0%)    0/24 (0%)    0/27 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |  9/25 (36%)  12/28 (43%)   4/19 (21%)  12/33 (36%) |
|-----------------------|                                                    |   536          549          534          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |                                                    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.131N     P=0.537      P=0.202N     P=0.236N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.279N     P=0.365      P=0.200N     P=0.447N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.226N     P=0.337      P=0.202N     P=0.458N   |
|FISHER EXACT           |                 (e)          (e)          (e)      |  P=0.231N                                          |
                                                                                             P=0.323      P=0.114N     P=0.500N 
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   3.1%         0.0%         6.5%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/32 (3%)    0/40 (0%)    2/31 (6%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      ---       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.571N     P=0.455N     P=0.489      P=0.506N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.571N     P=0.455N     P=0.489      P=0.506N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.571N     P=0.455N     P=0.489      P=0.506N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.529N                                          |    (e)          (e)          (e)          (e)      |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |    (e)                                             |
                                                                                               (e)          (e)          (e)
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   5.5%         2.5%         6.5%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/32 (3%)    1/40 (3%)    2/31 (6%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   578          729 (T)      729 (T)      ---       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.259N     P=0.443N     P=0.692N     P=0.246N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.213N     P=0.711N     P=0.659      P=0.219N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.231N     P=0.499N     P=0.682N     P=0.238N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.227N                                          |    (e)          (e)          (e)          (e)      |
|FISHER EXACT           |               P=0.500N     P=0.691N     P=0.247N   |    (e)                                             |
                                                                                               (e)          (e)          (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   3/50 (6%)    6/50 (12%) |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/51 (2%)  |
|ADJUSTED (b)           |  13.0%        12.1%         7.9%        15.8%      |   0.0%         0.0%         6.1%         2.6%      |
|TERMINAL (d)           |  2/32 (6%)    4/40 (10%)   1/31 (3%)    1/31 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   463          671          654          523       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          642          661       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396      P=0.527N     P=0.346N     P=0.485    |                                                    |
|INCIDENTAL TUMOR       |  P=0.535      P=0.578      P=0.277N     P=0.468    |  P=0.229        (e)        P=0.215      P=0.527    |
|LOGISTIC REGRESSION    |  P=0.462      P=0.631N     P=0.417N     P=0.506    |  P=0.049 *      (e)        P=0.215      P=0.077    |
|COCHRAN-ARMITAGE       |  P=0.463                                           |  P=0.212        (e)        P=0.227      P=0.501    |
|FISHER EXACT           |               P=0.630N     P=0.357N     P=0.500    |  P=0.213                                           |
                                                                                               (e)        P=0.247      P=0.505  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   5/50 (10%)   3/50 (6%)    6/50 (12%) |  0/50 (0%)    0/50 (0%)    2/50 (4%)    1/51 (2%)  |
|ADJUSTED (b)           |  13.0%        12.1%         7.9%        15.8%      |   0.0%         0.0%         6.1%         2.6%      |
|TERMINAL (d)           |  2/32 (6%)    4/40 (10%)   1/31 (3%)    1/31 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   463          671          654          523       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          642          661       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396      P=0.527N     P=0.346N     P=0.485    |                                                    |
|INCIDENTAL TUMOR       |  P=0.535      P=0.578      P=0.277N     P=0.468    |  P=0.229        (e)        P=0.215      P=0.527    |
|LOGISTIC REGRESSION    |  P=0.462      P=0.631N     P=0.417N     P=0.506    |  P=0.049 *      (e)        P=0.215      P=0.077    |
|COCHRAN-ARMITAGE       |  P=0.463                                           |  P=0.212        (e)        P=0.227      P=0.501    |
|FISHER EXACT           |               P=0.630N     P=0.357N     P=0.500    |  P=0.213                                           |
                                                                                               (e)        P=0.247      P=0.505  
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/49 (0%)    0/48 (0%)  |  0/49 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.3%         0.0%         0.0%         0.0%      |   0.0%         3.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/32 (6%)    0/40 (0%)    0/30 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          691          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.180N     P=0.191N     P=0.252N     P=0.245N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.180N     P=0.191N     P=0.252N     P=0.245N   |  P=0.432N     P=0.500        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.180N     P=0.191N     P=0.251N     P=0.245N   |  P=0.667N     P=0.419        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.165N                                          |  P=0.445N     P=0.506        (e)          (e)      |
|FISHER EXACT           |               P=0.247N     P=0.253N     P=0.258N   |  P=0.447N                                          |
                                                                                             P=0.505        (e)          (e)
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    3/50 (6%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/51 (0%)  |
|ADJUSTED (b)           |   3.1%         0.0%         8.7%         6.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/32 (3%)    0/40 (0%)    2/31 (6%)    2/31 (6%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          654          729 (T)   |  0/27 (0%)    0/32 (0%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   ---          ---          ---          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.148      P=0.455N     P=0.307      P=0.489    |                                                    |
|INCIDENTAL TUMOR       |  P=0.159      P=0.455N     P=0.351      P=0.489    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.168      P=0.455N     P=0.327      P=0.489    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.185                                           |    (e)          (e)          (e)          (e)      |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500    |    (e)                                             |
                                                                                               (e)          (e)          (e)
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    1/49 (2%)    2/50 (4%)    1/50 (2%)  |  0/48 (0%)    1/50 (2%)    1/50 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |   6.3%         2.5%         6.5%         3.2%      |   0.0%         3.1%         4.0%         5.4%      |
|TERMINAL (d)           |  2/32 (6%)    1/40 (3%)    2/31 (6%)    1/31 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |  0/27 (0%)    1/32 (3%)    1/25 (4%)    2/37 (5%)  |
|-----------------------|                                                    |   ---          730 (T)      730 (T)      730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.538N     P=0.422N     P=0.684      P=0.511N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.538N     P=0.422N     P=0.684      P=0.511N   |  P=0.228      P=0.534      P=0.485      P=0.310    |
|LOGISTIC REGRESSION    |  P=0.538N     P=0.422N     P=0.684      P=0.511N   |  P=0.228      P=0.534      P=0.485      P=0.310    |
|COCHRAN-ARMITAGE       |  P=0.470N                                          |  P=0.228      P=0.534      P=0.485      P=0.310    |
|FISHER EXACT           |               P=0.500N     P=0.684N     P=0.492N   |  P=0.173                                           |
                                                                                             P=0.510      P=0.510      P=0.258  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/49 (6%)    1/49 (2%)    3/50 (6%)    1/50 (2%)  |  0/48 (0%)    1/50 (2%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   9.4%         2.5%         9.0%         3.2%      |   0.0%         3.1%         8.0%         5.4%      |
|TERMINAL (d)           |  3/32 (9%)    1/40 (3%)    2/31 (6%)    1/31 (3%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      666          729 (T)   |  0/27 (0%)    1/32 (3%)    2/25 (8%)    2/37 (5%)  |
|-----------------------|                                                    |   ---          730 (T)      730 (T)      730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.436N     P=0.229N     P=0.653      P=0.316N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.415N     P=0.229N     P=0.629N     P=0.316N   |  P=0.229      P=0.534      P=0.221      P=0.310    |
|LOGISTIC REGRESSION    |  P=0.401N     P=0.229N     P=0.641N     P=0.316N   |  P=0.229      P=0.534      P=0.221      P=0.310    |
|COCHRAN-ARMITAGE       |  P=0.364N                                          |  P=0.229      P=0.534      P=0.221      P=0.310    |
|FISHER EXACT           |               P=0.309N     P=0.651N     P=0.301N   |  P=0.170                                           |
                                                                                             P=0.510      P=0.258      P=0.258  
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    2/50 (4%)    0/50 (0%)    1/51 (2%)  |
|ADJUSTED (b)           |   0.0%         2.5%         2.9%         0.0%      |   0.0%         6.3%         0.0%         2.6%      |
|TERMINAL (d)           |  0/32 (0%)    1/40 (3%)    0/31 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      687          ---       |  0/27 (0%)    2/32 (6%)    0/25 (0%)    1/38 (3%)  |
|-----------------------|                                                    |   ---          730 (T)      ---          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.563N     P=0.545      P=0.500        (e)      |                                                    |
|INCIDENTAL TUMOR       |  P=0.524N     P=0.545      P=0.623        (e)      |  P=0.572N     P=0.276        (e)        P=0.568    |
|LOGISTIC REGRESSION    |  P=0.544N     P=0.545      P=0.506        (e)      |  P=0.572N     P=0.276        (e)        P=0.568    |
|COCHRAN-ARMITAGE       |  P=0.536N                                          |  P=0.573N     P=0.276        (e)        P=0.568    |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |  P=0.639N                                          |
                                                                                             P=0.247        (e)        P=0.505  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    2/50 (4%)    1/50 (2%)  |  2/50 (4%)    3/50 (6%)    1/50 (2%)    0/51 (0%)  |
|ADJUSTED (b)           |  11.4%         5.0%         5.0%         2.4%      |   4.9%         9.1%         3.8%         0.0%      |
|TERMINAL (d)           |  3/32 (9%)    2/40 (5%)    0/31 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   541          729 (T)      650          570       |  0/27 (0%)    2/32 (6%)    0/25 (0%)    0/38 (0%)  |
|-----------------------|                                                    |   536          691          726          ---       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.192N     P=0.258N     P=0.333N     P=0.192N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.134N     P=0.276N     P=0.276N     P=0.175N   |  P=0.067N     P=0.537      P=0.532N     P=0.227N   |
|LOGISTIC REGRESSION    |  P=0.161N     P=0.327N     P=0.335N     P=0.181N   |  P=0.156N     P=0.378      P=0.552N     P=0.620N   |
|COCHRAN-ARMITAGE       |  P=0.160N                                          |  P=0.077N     P=0.494      P=0.489N     P=0.219N   |
|FISHER EXACT           |               P=0.339N     P=0.339N     P=0.181N   |  P=0.076N                                          |
                                                                                             P=0.500      P=0.500N     P=0.243N 
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    2/50 (4%)    3/50 (6%)    1/50 (2%)  |  2/50 (4%)    4/50 (8%)    1/50 (2%)    1/51 (2%)  |
|ADJUSTED (b)           |  11.4%         5.0%         7.8%         2.4%      |   4.9%        12.1%         3.8%         2.6%      |
|TERMINAL (d)           |  3/32 (9%)    2/40 (5%)    0/31 (0%)    0/31 (0%)  |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   541          729 (T)      650          570       |  0/27 (0%)    3/32 (9%)    0/25 (0%)    1/38 (3%)  |
|-----------------------|                                                    |   536          691          726          730 (T)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.232N     P=0.258N     P=0.493N     P=0.192N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.155N     P=0.276N     P=0.389N     P=0.175N   |  P=0.134N     P=0.385      P=0.532N     P=0.447N   |
|LOGISTIC REGRESSION    |  P=0.195N     P=0.327N     P=0.498N     P=0.181N   |  P=0.274N     P=0.251      P=0.552N     P=0.724    |
|COCHRAN-ARMITAGE       |  P=0.193N                                          |  P=0.164N     P=0.335      P=0.489N     P=0.497N   |
|FISHER EXACT           |               P=0.339N     P=0.500N     P=0.181N   |  P=0.163N                                          |
                                                                                             P=0.339      P=0.500N     P=0.492N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/50 (16%)   4/50 (8%)    4/50 (8%)    2/50 (4%)  | 11/50 (22%)  11/50 (22%)   8/50 (16%)  17/51 (33%) |
|ADJUSTED (b)           |  22.8%         9.7%        12.0%         6.5%      |  30.1%        27.9%        28.5%        37.1%      |
|TERMINAL (d)           |  6/32 (19%)   3/40 (8%)    2/31 (6%)    2/31 (6%)  |  0/0          0/0          0/0          1/1 (100%) |
|FIRST INCIDENCE (DAYS) |   267          651          687          729 (T)   |  5/27 (19%)   6/32 (19%)   5/25 (20%)  10/38 (26%) |
|-----------------------|                                                    |   506          516          701          457 (I)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.085N     P=0.106N     P=0.197N     P=0.055N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.061N     P=0.150N     P=0.185N     P=0.050N   |  P=0.320      P=0.495N     P=0.397N     P=0.417    |
|LOGISTIC REGRESSION    |  P=0.056N     P=0.175N     P=0.165N     P=0.050N   |  P=0.097      P=0.577      P=0.394N     P=0.116    |
|COCHRAN-ARMITAGE       |  P=0.055N                                          |  P=0.110      P=0.580      P=0.379N     P=0.131    |
|FISHER EXACT           |               P=0.178N     P=0.178N     P=0.046N*  |  P=0.110                                           |
                                                                                             P=0.595N     P=0.306N     P=0.147  
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)   4/50 (8%)    3/50 (6%)    2/50 (4%)  | 10/50 (20%)  10/50 (20%)   7/50 (14%)  16/51 (31%) |
|ADJUSTED (b)           |  19.9%         9.7%         9.4%         6.5%      |  26.9%        25.1%        24.9%        35.8%      |
|TERMINAL (d)           |  5/32 (16%)   3/40 (8%)    2/31 (6%)    2/31 (6%)  |  0/0          0/0          0/0          1/1 (100%) |
|FIRST INCIDENCE (DAYS) |   267          651          715          729 (T)   |  4/27 (15%)   5/32 (16%)   4/25 (16%)  10/38 (26%) |
|-----------------------|                                                    |   506          516          701          457 (I)   |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.101N     P=0.173N     P=0.175N     P=0.092N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.079N     P=0.236N     P=0.190N     P=0.085N   |  P=0.296      P=0.510N     P=0.386N     P=0.397    |
|LOGISTIC REGRESSION    |  P=0.070N     P=0.259N     P=0.152N     P=0.084N   |  P=0.087      P=0.564      P=0.382N     P=0.126    |
|COCHRAN-ARMITAGE       |  P=0.068N                                          |  P=0.102      P=0.579      P=0.358N     P=0.128    |
|FISHER EXACT           |               P=0.262N     P=0.159N     P=0.080N   |  P=0.102                                           |
                                                                                             P=0.598N     P=0.298N     P=0.140  
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/50 (46%)  22/50 (44%)  21/50 (42%)  20/50 (40%) | 22/50 (44%)  22/50 (44%)  17/50 (34%)  22/51 (43%) |
|ADJUSTED (b)           |  60.1%        52.3%        54.4%        56.3%      |  61.6%        57.5%        51.7%        54.8%      |
|TERMINAL (d)           | 17/32 (53%)  20/40 (50%)  14/31 (45%)  16/31 (52%) |  0/0          0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   479          502          512          512       | 14/27 (52%)  16/32 (50%)  10/25 (40%)  20/38 (53%) |
|-----------------------|                                                    |   536          634          534          596       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.532      P=0.188N     P=0.441N     P=0.396N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.374N     P=0.430N     P=0.295N     P=0.392N   |  P=0.167N     P=0.370N     P=0.335N     P=0.151N   |
|LOGISTIC REGRESSION    |  P=0.339N     P=0.430N     P=0.302N     P=0.374N   |  P=0.418N     P=0.483N     P=0.324N     P=0.388N   |
|COCHRAN-ARMITAGE       |  P=0.299N                                          |  P=0.375N     P=0.543N     P=0.336N     P=0.437N   |
|FISHER EXACT           |               P=0.500N     P=0.420N     P=0.343N   |  P=0.428N                                          |
                                                                                             P=0.580N     P=0.206N     P=0.545N 
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 25/50 (50%)  14/50 (28%)  17/50 (34%)  13/50 (26%) | 20/50 (40%)  15/50 (30%)  14/50 (28%)  19/51 (37%) |
|ADJUSTED (b)           |  56.3%        32.6%        40.6%        31.8%      |  50.0%        38.1%        42.0%        39.9%      |
|TERMINAL (d)           | 13/32 (41%)  11/40 (28%)   7/31 (23%)   4/31 (13%) |  0/0          0/0          0/0          1/1 (100%) |
|FIRST INCIDENCE (DAYS) |   267          651          647          523       |  9/27 (33%)   9/32 (28%)   6/25 (24%)  10/38 (26%) |
|-----------------------|                                                    |   506          516          642          251       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.136N     P=0.009N**   P=0.112N     P=0.035N*  |                                                    |
|INCIDENTAL TUMOR       |  P=0.011N*    P=0.086N     P=0.022N*    P=0.008N** |  P=0.289N     P=0.146N     P=0.269N     P=0.193N   |
|LOGISTIC REGRESSION    |  P=0.024N*    P=0.020N*    P=0.085N     P=0.012N*  |  P=0.377      P=0.227N     P=0.244N     P=0.525N   |
|COCHRAN-ARMITAGE       |  P=0.046N*                                         |  P=0.522      P=0.207N     P=0.250N     P=0.537N   |
|FISHER EXACT           |               P=0.020N*    P=0.078N     P=0.011N*  |  P=0.523                                           |
                                                                                             P=0.201N     P=0.146N     P=0.469N 
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 02                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   CONTROL      0.06% LM     0.3% MM      0.6% HM   |   CONTROL      0.06% LF     0.3% MF      0.6% HF   |
|                       |   UM                                               |   UF                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 35/50 (70%)  29/50 (58%)  31/50 (62%)  28/50 (56%) | 35/50 (70%)  28/50 (56%)  24/50 (48%)  35/51 (69%) |
|ADJUSTED (b)           |  77.6%        65.9%        70.1%        66.3%      |  81.0%        67.7%        66.2%        72.8%      |
|TERMINAL (d)           | 22/32 (69%)  25/40 (63%)  18/31 (58%)  17/31 (55%) |  0/0          0/0          0/0          1/1 (100%) |
|FIRST INCIDENCE (DAYS) |   267          502          512          512       | 19/27 (70%)  19/32 (59%)  13/25 (52%)  25/38 (66%) |
|-----------------------|                                                    |   506          516          534          251       |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.466N     P=0.030N*    P=0.314N     P=0.207N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.121N     P=0.238N     P=0.124N     P=0.113N   |  P=0.210N     P=0.061N     P=0.123N     P=0.085N   |
|LOGISTIC REGRESSION    |  P=0.143N     P=0.136N     P=0.195N     P=0.133N   |  P=0.385      P=0.093N     P=0.064N     P=0.517N   |
|COCHRAN-ARMITAGE       |  P=0.173N                                          |  P=0.440      P=0.093N     P=0.060N     P=0.520N   |
|FISHER EXACT           |               P=0.149N     P=0.263N     P=0.107N   |  P=0.444                                           |
                                                                                             P=0.107N     P=0.021N*    P=0.526N 
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):  
          Female interim sacrifices(days): 457
 (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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