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TDMS Study 05035-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                4-HYDROXYACETANILIDE                                 DATE: 09/05/94       
EXPERIMENT: 05035 TEST: 03                                                                                     TIME: 00:30:23       
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: 09/05/94      
EXPERIMENT: 05035 TEST: 03                                                                                     TIME: 00:30:23      
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       
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                                4-HYDROXYACETANILIDE                                 DATE: 09/05/94       
EXPERIMENT: 05035 TEST: 03                                                                                     TIME: 00:30:23       
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 RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pancreas                      Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Testes                        Adenoma
                             All Organs                    Mesothelioma Benign, Malignant, NOS
                                                           Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Skin: Subcutaneous Tissue     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
                                                            Neurofibroma, or Fibroma
                             Thyroid Gland: Follicular Cell
                                                           Carcinoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Tumors
 
              ====================================================================================================
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   1
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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)            | 16/44 (36%)  20/49 (41%)  17/49 (35%)  19/46 (41%) |  3/39 (8%)    6/47 (13%)   6/44 (14%)   4/47 (9%)  |
|ADJUSTED (b)           |  51.4%        54.6%        57.0%        63.0%      |  12.5%        17.8%        18.4%        16.0%      |
|TERMINAL (d)           | 10/24 (42%)  12/28 (43%)  10/22 (45%)  12/22 (55%) |  3/24 (13%)   5/32 (16%)   4/29 (14%)   4/25 (16%) |
|FIRST INCIDENCE (DAYS) |   635          549          642          586       |   729 (T)      689          644          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.230      P=0.444      P=0.401      P=0.250    |  P=0.502      P=0.389      P=0.325      P=0.523    |
|INCIDENTAL TUMOR       |  P=0.300      P=0.524      P=0.533N     P=0.321    |  P=0.558      P=0.392      P=0.288      P=0.523    |
|LOGISTIC REGRESSION    |  P=0.277      P=0.490      P=0.497N     P=0.296    |  P=0.541      P=0.399      P=0.315      P=0.523    |
|COCHRAN-ARMITAGE       |  P=0.443                                           |  P=0.485N                                          |
|FISHER EXACT           |               P=0.411      P=0.519N     P=0.396    |               P=0.344      P=0.306      P=0.605    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/44 (2%)    2/49 (4%)    2/49 (4%)    2/46 (4%)  |  0/39 (0%)    1/47 (2%)    0/44 (0%)    0/47 (0%)  |
|ADJUSTED (b)           |   4.2%         7.1%         9.1%         7.4%      |   0.0%         2.4%         0.0%         0.0%      |
|TERMINAL (d)           |  1/24 (4%)    2/28 (7%)    2/22 (9%)    1/22 (5%)  |  0/24 (0%)    0/32 (0%)    0/29 (0%)    0/25 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      669       |   ---          644          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.372      P=0.554      P=0.469      P=0.476    |  P=0.469N     P=0.510        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.379      P=0.554      P=0.469      P=0.493    |  P=0.401N     P=0.531        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.384      P=0.554      P=0.469      P=0.492    |  P=0.416N     P=0.503        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.444                                           |  P=0.433N                                          |
|FISHER EXACT           |               P=0.541      P=0.541      P=0.517    |               P=0.547        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   2
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/44 (39%)  22/49 (45%)  19/49 (39%)  21/46 (46%) |  3/39 (8%)    7/47 (15%)   6/44 (14%)   4/47 (9%)  |
|ADJUSTED (b)           |  54.9%        60.3%        64.2%        67.7%      |  12.5%        19.8%        18.4%        16.0%      |
|TERMINAL (d)           | 11/24 (46%)  14/28 (50%)  12/22 (55%)  13/22 (59%) |  3/24 (13%)   5/32 (16%)   4/29 (14%)   4/25 (16%) |
|FIRST INCIDENCE (DAYS) |   635          549          642          586       |   729 (T)      644          644          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.175      P=0.387      P=0.317      P=0.190    |  P=0.553N     P=0.277      P=0.325      P=0.523    |
|INCIDENTAL TUMOR       |  P=0.226      P=0.456      P=0.547      P=0.242    |  P=0.479N     P=0.285      P=0.288      P=0.523    |
|LOGISTIC REGRESSION    |  P=0.208      P=0.429      P=0.513      P=0.184    |  P=0.497N     P=0.287      P=0.315      P=0.523    |
|COCHRAN-ARMITAGE       |  P=0.386                                           |  P=0.410N                                          |
|FISHER EXACT           |               P=0.345      P=0.579      P=0.323    |               P=0.245      P=0.306      P=0.605    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/48 (4%)    6/50 (12%)   2/49 (4%)    5/47 (11%) |  5/43 (12%)   1/47 (2%)    6/43 (14%)   5/40 (13%) |
|ADJUSTED (b)           |   6.9%        19.6%         6.4%        17.8%      |  17.2%         3.0%        19.9%        18.8%      |
|TERMINAL (d)           |  1/25 (4%)    5/28 (18%)   1/23 (4%)    3/24 (13%) |  5/29 (17%)   1/33 (3%)    5/28 (18%)   3/22 (14%) |
|FIRST INCIDENCE (DAYS) |   682          600          521          577       |   729 (T)      729 (T)      611          640       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.346      P=0.170      P=0.671      P=0.205    |  P=0.114      P=0.074N     P=0.477      P=0.475    |
|INCIDENTAL TUMOR       |  P=0.366      P=0.163      P=0.624N     P=0.215    |  P=0.142      P=0.074N     P=0.489      P=0.518    |
|LOGISTIC REGRESSION    |  P=0.376      P=0.163      P=0.682N     P=0.207    |  P=0.125      P=0.074N     P=0.463      P=0.493    |
|COCHRAN-ARMITAGE       |  P=0.382                                           |  P=0.187                                           |
|FISHER EXACT           |               P=0.148      P=0.684N     P=0.209    |               P=0.082N     P=0.500      P=0.583    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   3
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/48 (6%)    6/50 (12%)   3/49 (6%)    5/47 (11%) |  4/43 (9%)    5/47 (11%)   3/43 (7%)    2/40 (5%)  |
|ADJUSTED (b)           |  12.0%        16.6%        10.0%        16.1%      |  12.3%        13.9%        10.7%         6.5%      |
|TERMINAL (d)           |  3/25 (12%)   2/28 (7%)    1/23 (4%)    3/24 (13%) |  2/29 (7%)    3/33 (9%)    3/28 (11%)   1/22 (5%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      549          642          533       |   679          670          729 (T)      308       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.429      P=0.296      P=0.631      P=0.338    |  P=0.275N     P=0.574      P=0.503N     P=0.426N   |
|INCIDENTAL TUMOR       |  P=0.456      P=0.296      P=0.641      P=0.300    |  P=0.136N     P=0.546      P=0.600N     P=0.231N   |
|LOGISTIC REGRESSION    |  P=0.463      P=0.271      P=0.661N     P=0.344    |  P=0.214N     P=0.570      P=0.528N     P=0.297N   |
|COCHRAN-ARMITAGE       |  P=0.462                                           |  P=0.212N                                          |
|FISHER EXACT           |               P=0.264      P=0.651N     P=0.345    |               P=0.557      P=0.500N     P=0.373N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/48 (10%)  12/50 (24%)   5/49 (10%)  10/47 (21%) |  9/43 (21%)   6/47 (13%)   8/43 (19%)   7/40 (18%) |
|ADJUSTED (b)           |  18.5%        34.1%        16.0%        32.5%      |  28.5%        16.8%        26.8%        24.6%      |
|TERMINAL (d)           |  4/25 (16%)   7/28 (25%)   2/23 (9%)    6/24 (25%) |  7/29 (24%)   4/33 (12%)   7/28 (25%)   4/22 (18%) |
|FIRST INCIDENCE (DAYS) |   682          549          521          533       |   679          670          611          308       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.298      P=0.090      P=0.588      P=0.119    |  P=0.386      P=0.209N     P=0.519N     P=0.579N   |
|INCIDENTAL TUMOR       |  P=0.325      P=0.083      P=0.599N     P=0.107    |  P=0.549N     P=0.219N     P=0.576N     P=0.418N   |
|LOGISTIC REGRESSION    |  P=0.337      P=0.074      P=0.623N     P=0.121    |  P=0.455      P=0.199N     P=0.549N     P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.340                                           |  P=0.527                                           |
|FISHER EXACT           |               P=0.065      P=0.617N     P=0.121    |               P=0.225N     P=0.500N     P=0.454N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   4
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    4/49 (8%)    2/46 (4%)    1/48 (2%)  |  1/46 (2%)    2/49 (4%)    1/48 (2%)    1/47 (2%)  |
|ADJUSTED (b)           |   7.7%        13.1%         7.4%         4.2%      |   3.4%         5.6%         3.1%         2.4%      |
|TERMINAL (d)           |  2/26 (8%)    3/27 (11%)   1/22 (5%)    1/24 (4%)  |  1/29 (3%)    1/34 (3%)    1/32 (3%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      613          661          729 (T)   |   729 (T)      694          729 (T)      611       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.249N     P=0.353      P=0.643      P=0.528N   |  P=0.517N     P=0.550      P=0.740N     P=0.755    |
|INCIDENTAL TUMOR       |  P=0.242N     P=0.335      P=0.649      P=0.528N   |  P=0.489N     P=0.504      P=0.740N     P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.237N     P=0.357      P=0.652      P=0.528N   |  P=0.498N     P=0.539      P=0.740N     P=0.758N   |
|COCHRAN-ARMITAGE       |  P=0.216N                                          |  P=0.478N                                          |
|FISHER EXACT           |               P=0.339      P=0.667      P=0.508N   |               P=0.524      P=0.742N     P=0.747N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/49 (4%)    5/49 (10%)   3/46 (7%)    1/48 (2%)  |  1/46 (2%)    2/49 (4%)    1/48 (2%)    1/47 (2%)  |
|ADJUSTED (b)           |   7.7%        15.7%        11.8%         4.2%      |   3.4%         5.6%         3.1%         2.4%      |
|TERMINAL (d)           |  2/26 (8%)    3/27 (11%)   2/22 (9%)    1/24 (4%)  |  1/29 (3%)    1/34 (3%)    1/32 (3%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      613          661          729 (T)   |   729 (T)      694          729 (T)      611       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.226N     P=0.234      P=0.434      P=0.528N   |  P=0.517N     P=0.550      P=0.740N     P=0.755    |
|INCIDENTAL TUMOR       |  P=0.221N     P=0.228      P=0.439      P=0.528N   |  P=0.489N     P=0.504      P=0.740N     P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.215N     P=0.232      P=0.443      P=0.528N   |  P=0.498N     P=0.539      P=0.740N     P=0.758N   |
|COCHRAN-ARMITAGE       |  P=0.194N                                          |  P=0.478N                                          |
|FISHER EXACT           |               P=0.218      P=0.470      P=0.508N   |               P=0.524      P=0.742N     P=0.747N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   5
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    0/50 (0%)    3/50 (6%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  11.1%         0.0%        13.0%        12.5%      |   0.0%         0.0%         0.0%         2.9%      |
|TERMINAL (d)           |  3/27 (11%)   0/28 (0%)    3/23 (13%)   3/24 (13%) |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      729 (T)   |   ---          ---          ---          668       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.220      P=0.113N     P=0.589      P=0.610    |  P=0.170        (e)          (e)        P=0.483    |
|INCIDENTAL TUMOR       |  P=0.220      P=0.113N     P=0.589      P=0.610    |  P=0.192        (e)          (e)        P=0.477    |
|LOGISTIC REGRESSION    |  P=0.220      P=0.113N     P=0.589      P=0.610    |  P=0.190        (e)          (e)        P=0.501    |
|COCHRAN-ARMITAGE       |  P=0.287                                           |  P=0.186                                           |
|FISHER EXACT           |               P=0.121N     P=0.661N     P=0.661N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    2/50 (4%)    3/50 (6%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.4%         5.9%         7.5%         8.7%      |   2.4%         2.9%         0.0%         0.0%      |
|TERMINAL (d)           |  2/27 (7%)    1/28 (4%)    1/23 (4%)    1/24 (4%)  |  0/30 (0%)    1/34 (3%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      635          703          585       |   607          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.324      P=0.682N     P=0.644      P=0.457    |  P=0.217N     P=0.739N     P=0.505N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.368      P=0.686      P=0.675      P=0.484    |  P=0.201N     P=0.747N     P=0.531N     P=0.450N   |
|LOGISTIC REGRESSION    |  P=0.373      P=0.683N     P=0.673      P=0.503    |  P=0.201N     P=0.750      P=0.500N     P=0.472N   |
|COCHRAN-ARMITAGE       |  P=0.381                                           |  P=0.208N                                          |
|FISHER EXACT           |               P=0.691N     P=0.691N     P=0.500    |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   6
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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 or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    2/50 (4%)    4/50 (8%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   7.4%         9.4%         7.5%        12.7%      |   2.4%         2.9%         0.0%         3.6%      |
|TERMINAL (d)           |  2/27 (7%)    2/28 (7%)    1/23 (4%)    2/24 (8%)  |  0/30 (0%)    1/34 (3%)    0/34 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      635          703          585       |   607          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.245      P=0.516      P=0.644      P=0.295    |  P=0.611N     P=0.739N     P=0.505N     P=0.753    |
|INCIDENTAL TUMOR       |  P=0.281      P=0.495      P=0.675      P=0.315    |  P=0.584N     P=0.747N     P=0.531N     P=0.741N   |
|LOGISTIC REGRESSION    |  P=0.285      P=0.520      P=0.673      P=0.331    |  P=0.594N     P=0.750      P=0.500N     P=0.762N   |
|COCHRAN-ARMITAGE       |  P=0.304                                           |  P=0.588N                                          |
|FISHER EXACT           |               P=0.500      P=0.691N     P=0.339    |               P=0.753N     P=0.500N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         2.9%         2.9%         5.5%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    0/24 (0%)  |  0/30 (0%)    1/34 (3%)    1/34 (3%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          729 (T)      729 (T)      611       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.148      P=0.525      P=0.525      P=0.235    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.170      P=0.525      P=0.525      P=0.254    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.161      P=0.525      P=0.525      P=0.245    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.168                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.500      P=0.247    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   7
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    5/50 (10%)   1/50 (2%)    1/50 (2%)  | 19/50 (38%)  24/50 (48%)  20/50 (40%)  18/50 (36%) |
|ADJUSTED (b)           |  14.8%        15.9%         3.8%         3.1%      |  47.8%        61.0%        52.0%        52.9%      |
|TERMINAL (d)           |  4/27 (15%)   3/28 (11%)   0/23 (0%)    0/24 (0%)  | 10/30 (33%)  19/34 (56%)  16/34 (47%)  13/28 (46%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      670          715          695       |   517          576          506          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.067N     P=0.535      P=0.225N     P=0.209N   |  P=0.426N     P=0.384      P=0.514N     P=0.555    |
|INCIDENTAL TUMOR       |  P=0.054N     P=0.543      P=0.202N     P=0.203N   |  P=0.372N     P=0.239      P=0.420      P=0.524    |
|LOGISTIC REGRESSION    |  P=0.056N     P=0.545      P=0.201N     P=0.197N   |  P=0.338N     P=0.261      P=0.507      P=0.540N   |
|COCHRAN-ARMITAGE       |  P=0.045N*                                         |  P=0.261N                                          |
|FISHER EXACT           |               P=0.500      P=0.181N     P=0.181N   |               P=0.210      P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    5/50 (10%)   1/50 (2%)    1/50 (2%)  | 19/50 (38%)  24/50 (48%)  20/50 (40%)  20/50 (40%) |
|ADJUSTED (b)           |  14.8%        15.9%         3.8%         3.1%      |  47.8%        61.0%        52.0%        55.5%      |
|TERMINAL (d)           |  4/27 (15%)   3/28 (11%)   0/23 (0%)    0/24 (0%)  | 10/30 (33%)  19/34 (56%)  16/34 (47%)  13/28 (46%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      670          715          695       |   517          576          506          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.067N     P=0.535      P=0.225N     P=0.209N   |  P=0.473      P=0.384      P=0.514N     P=0.407    |
|INCIDENTAL TUMOR       |  P=0.054N     P=0.543      P=0.202N     P=0.203N   |  P=0.529      P=0.239      P=0.420      P=0.368    |
|LOGISTIC REGRESSION    |  P=0.056N     P=0.545      P=0.201N     P=0.197N   |  P=0.509N     P=0.261      P=0.507      P=0.463    |
|COCHRAN-ARMITAGE       |  P=0.045N*                                         |  P=0.421N                                          |
|FISHER EXACT           |               P=0.500      P=0.181N     P=0.181N   |               P=0.210      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   8
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/49 (0%)    0/49 (0%)    0/47 (0%)    2/47 (4%)  |  0/47 (0%)    0/49 (0%)    0/49 (0%)    0/48 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         8.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/26 (0%)    0/27 (0%)    0/22 (0%)    2/24 (8%)  |  0/30 (0%)    0/34 (0%)    0/33 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.038 *      (e)          (e)        P=0.220    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.038 *      (e)          (e)        P=0.220    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.038 *      (e)          (e)        P=0.220    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.040 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.237    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/48 (33%)  27/49 (55%)  19/49 (39%)  19/48 (40%) | 23/47 (49%)  31/50 (62%)  27/50 (54%)  24/49 (49%) |
|ADJUSTED (b)           |  45.0%        62.0%        56.7%        51.7%      |  60.5%        71.3%        66.9%        68.9%      |
|TERMINAL (d)           |  9/27 (33%)  12/28 (43%)  10/23 (43%)   8/24 (33%) | 14/28 (50%)  22/34 (65%)  21/34 (62%)  17/27 (63%) |
|FIRST INCIDENCE (DAYS) |   568          549          582          564       |   517          501          456          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.479      P=0.068      P=0.227      P=0.262    |  P=0.531      P=0.309      P=0.540      P=0.435    |
|INCIDENTAL TUMOR       |  P=0.443N     P=0.026 *    P=0.271      P=0.293    |  P=0.445N     P=0.185      P=0.379      P=0.436    |
|LOGISTIC REGRESSION    |  P=0.414N     P=0.025 *    P=0.337      P=0.314    |  P=0.374N     P=0.152      P=0.387      P=0.522    |
|COCHRAN-ARMITAGE       |  P=0.374N                                          |  P=0.296N                                          |
|FISHER EXACT           |               P=0.025 *    P=0.365      P=0.336    |               P=0.138      P=0.384      P=0.579    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE   9
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/48 (2%)    0/49 (0%)    0/49 (0%)    1/48 (2%)  |  1/47 (2%)    0/50 (0%)    2/50 (4%)    1/49 (2%)  |
|ADJUSTED (b)           |   2.1%         0.0%         0.0%         4.2%      |   3.6%         0.0%         5.9%         3.7%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    1/24 (4%)  |  1/28 (4%)    0/34 (0%)    2/34 (6%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |   568          ---          ---          729 (T)   |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.512      P=0.500N     P=0.517N     P=0.743    |  P=0.390      P=0.461N     P=0.568      P=0.754    |
|INCIDENTAL TUMOR       |  P=0.535      P=0.540N     P=0.540N     P=0.757    |  P=0.390      P=0.461N     P=0.568      P=0.754    |
|LOGISTIC REGRESSION    |  P=0.577      P=0.486N     P=0.366N     P=0.740N   |  P=0.390      P=0.461N     P=0.568      P=0.754    |
|COCHRAN-ARMITAGE       |  P=0.535                                           |  P=0.430                                           |
|FISHER EXACT           |               P=0.495N     P=0.495N     P=0.753N   |               P=0.485N     P=0.523      P=0.742N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/48 (35%)  27/49 (55%)  19/49 (39%)  20/48 (42%) | 24/47 (51%)  31/50 (62%)  29/50 (58%)  25/49 (51%) |
|ADJUSTED (b)           |  46.2%        62.0%        56.7%        54.7%      |  63.4%        71.3%        72.0%        72.0%      |
|TERMINAL (d)           |  9/27 (33%)  12/28 (43%)  10/23 (43%)   9/24 (38%) | 15/28 (54%)  22/34 (65%)  23/34 (68%)  18/27 (67%) |
|FIRST INCIDENCE (DAYS) |   568          549          582          564       |   517          501          456          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.450      P=0.096      P=0.288      P=0.262    |  P=0.469      P=0.379      P=0.489      P=0.432    |
|INCIDENTAL TUMOR       |  P=0.473N     P=0.039 *    P=0.338      P=0.293    |  P=0.514N     P=0.250      P=0.323      P=0.433    |
|LOGISTIC REGRESSION    |  P=0.438N     P=0.039 *    P=0.429      P=0.323    |  P=0.442N     P=0.210      P=0.316      P=0.519    |
|COCHRAN-ARMITAGE       |  P=0.403N                                          |  P=0.346N                                          |
|FISHER EXACT           |               P=0.040 *    P=0.448      P=0.338    |               P=0.189      P=0.315      P=0.579N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  10
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/50 (4%)    2/50 (4%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.2%         7.1%         6.6%         3.1%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    2/28 (7%)    1/23 (4%)    0/24 (0%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   631          729 (T)      620          695       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.291N     P=0.493N     P=0.530N     P=0.333N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.240N     P=0.549N     P=0.591N     P=0.271N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.238N     P=0.517N     P=0.468N     P=0.275N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.246N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   6.4%         0.0%         0.0%         7.2%      |   0.0%         2.9%         2.9%         3.6%      |
|TERMINAL (d)           |  1/27 (4%)    0/28 (0%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    1/34 (3%)    1/34 (3%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   661          ---          ---          695       |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.388      P=0.227N     P=0.264N     P=0.663    |  P=0.381      P=0.525      P=0.525      P=0.486    |
|INCIDENTAL TUMOR       |  P=0.404      P=0.216N     P=0.227N     P=0.691    |  P=0.381      P=0.525      P=0.525      P=0.486    |
|LOGISTIC REGRESSION    |  P=0.403      P=0.234N     P=0.243N     P=0.679    |  P=0.381      P=0.525      P=0.525      P=0.486    |
|COCHRAN-ARMITAGE       |  P=0.424                                           |  P=0.412                                           |
|FISHER EXACT           |               P=0.247N     P=0.247N     P=0.691N   |               P=0.500      P=0.500      P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  11
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |   6.4%         0.0%         0.0%         4.2%      |   0.0%         2.9%         2.9%         3.6%      |
|TERMINAL (d)           |  1/27 (4%)    0/28 (0%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    1/34 (3%)    1/34 (3%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   661          ---          ---          729 (T)   |   ---          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.570N     P=0.227N     P=0.264N     P=0.537N   |  P=0.381      P=0.525      P=0.525      P=0.486    |
|INCIDENTAL TUMOR       |  P=0.555N     P=0.216N     P=0.227N     P=0.516N   |  P=0.381      P=0.525      P=0.525      P=0.486    |
|LOGISTIC REGRESSION    |  P=0.550N     P=0.234N     P=0.243N     P=0.517N   |  P=0.381      P=0.525      P=0.525      P=0.486    |
|COCHRAN-ARMITAGE       |  P=0.529N                                          |  P=0.412                                           |
|FISHER EXACT           |               P=0.247N     P=0.247N     P=0.500N   |               P=0.500      P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.1%         0.0%         0.0%         8.3%      |   2.4%         2.9%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    2/24 (8%)  |  0/30 (0%)    1/34 (3%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   703          ---          ---          729 (T)   |   607          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.180      P=0.494N     P=0.513N     P=0.461    |  P=0.217N     P=0.739N     P=0.505N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.189      P=0.464N     P=0.448N     P=0.484    |  P=0.201N     P=0.747N     P=0.531N     P=0.450N   |
|LOGISTIC REGRESSION    |  P=0.186      P=0.494N     P=0.508N     P=0.478    |  P=0.201N     P=0.750      P=0.500N     P=0.472N   |
|COCHRAN-ARMITAGE       |  P=0.208                                           |  P=0.208N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |               P=0.753N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  12
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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)            |  6/50 (12%)   2/50 (4%)    2/50 (4%)    5/50 (10%) |  1/50 (2%)    2/50 (4%)    1/50 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |  15.8%         7.1%         6.6%        18.0%      |   2.4%         5.9%         2.9%         3.6%      |
|TERMINAL (d)           |  1/27 (4%)    2/28 (7%)    1/23 (4%)    3/24 (13%) |  0/30 (0%)    2/34 (6%)    1/34 (3%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   631          729 (T)      620          695       |   607          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.438      P=0.134N     P=0.170N     P=0.557N   |  P=0.509N     P=0.537      P=0.749N     P=0.753    |
|INCIDENTAL TUMOR       |  P=0.501      P=0.141N     P=0.156N     P=0.489N   |  P=0.489N     P=0.529      P=0.758      P=0.741N   |
|LOGISTIC REGRESSION    |  P=0.491      P=0.139N     P=0.125N     P=0.596N   |  P=0.499N     P=0.500      P=0.762      P=0.762N   |
|COCHRAN-ARMITAGE       |  P=0.514                                           |  P=0.477N                                          |
|FISHER EXACT           |               P=0.134N     P=0.134N     P=0.500N   |               P=0.500      P=0.753N     P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   4/50 (8%)    2/50 (4%)    0/50 (0%)  |  2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  15.1%        11.5%         5.8%         0.0%      |   6.7%         5.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    2/28 (7%)    0/23 (0%)    0/24 (0%)  |  2/30 (7%)    1/34 (3%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   514          613          655          ---       |   729 (T)      562          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.015N*    P=0.348N     P=0.165N     P=0.025N*  |  P=0.076N     P=0.656N     P=0.211N     P=0.253N   |
|INCIDENTAL TUMOR       |  P=0.006N**   P=0.399N     P=0.067N     P=0.014N*  |  P=0.071N     P=0.660N     P=0.211N     P=0.253N   |
|LOGISTIC REGRESSION    |  P=0.005N**   P=0.421N     P=0.102N     P=0.010N*  |  P=0.071N     P=0.695      P=0.211N     P=0.253N   |
|COCHRAN-ARMITAGE       |  P=0.009N**                                        |  P=0.070N                                          |
|FISHER EXACT           |               P=0.370N     P=0.134N     P=0.013N*  |               P=0.691N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  13
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)  |  2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.0%         2.2%      |   5.3%         0.0%         0.0%         6.6%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    0/24 (0%)  |  1/30 (3%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          719          577       |   396          ---          ---          690       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.198        (e)        P=0.485      P=0.500    |  P=0.394      P=0.224N     P=0.226N     P=0.670    |
|INCIDENTAL TUMOR       |  P=0.228        (e)        P=0.552      P=0.517    |  P=0.383      P=0.298N     P=0.183N     P=0.605    |
|LOGISTIC REGRESSION    |  P=0.229        (e)        P=0.488      P=0.576    |  P=0.482      P=0.353N     P=0.233N     P=0.669N   |
|COCHRAN-ARMITAGE       |  P=0.208                                           |  P=0.424                                           |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |               P=0.247N     P=0.247N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   5/50 (10%)   3/50 (6%)    1/50 (2%)  |  4/50 (8%)    2/50 (4%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |  15.1%        14.9%         9.6%         2.2%      |  11.8%         5.0%         0.0%         6.6%      |
|TERMINAL (d)           |  0/27 (0%)    3/28 (11%)   0/23 (0%)    0/24 (0%)  |  3/30 (10%)   1/34 (3%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   514          613          655          577       |   396          562          ---          690       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.049N*    P=0.470N     P=0.283N     P=0.076N   |  P=0.278N     P=0.297N     P=0.053N     P=0.369N   |
|INCIDENTAL TUMOR       |  P=0.023N*    P=0.527N     P=0.132N     P=0.046N*  |  P=0.273N     P=0.350N     P=0.042N*    P=0.426N   |
|LOGISTIC REGRESSION    |  P=0.021N*    P=0.548N     P=0.205N     P=0.033N*  |  P=0.220N     P=0.406N     P=0.062N     P=0.329N   |
|COCHRAN-ARMITAGE       |  P=0.030N*                                         |  P=0.246N                                          |
|FISHER EXACT           |               P=0.500N     P=0.243N     P=0.056N   |               P=0.339N     P=0.059N     P=0.339N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  14
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)  |  2/50 (4%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         3.6%         4.0%         2.2%      |   5.3%         0.0%         0.0%         6.6%      |
|TERMINAL (d)           |  0/27 (0%)    1/28 (4%)    0/23 (0%)    0/24 (0%)  |  1/30 (3%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      719          577       |   396          ---          ---          690       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.386      P=0.507      P=0.485      P=0.500    |  P=0.394      P=0.224N     P=0.226N     P=0.670    |
|INCIDENTAL TUMOR       |  P=0.417      P=0.507      P=0.552      P=0.517    |  P=0.383      P=0.298N     P=0.183N     P=0.605    |
|LOGISTIC REGRESSION    |  P=0.418      P=0.507      P=0.488      P=0.576    |  P=0.482      P=0.353N     P=0.233N     P=0.669N   |
|COCHRAN-ARMITAGE       |  P=0.412                                           |  P=0.424                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.247N     P=0.247N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.3%         2.9%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    0/24 (0%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          692          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.115N     P=0.489N     P=0.249N     P=0.264N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.095N     P=0.481N     P=0.232N     P=0.220N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.098N     P=0.516N     P=0.224N     P=0.223N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.105N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.247N     P=0.247N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  15
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 42/50 (84%)  45/50 (90%)  48/50 (96%)  42/50 (84%) |                                                    |
|ADJUSTED (b)           |  97.6%        95.7%       100.0%        97.5%      |                                                    |
|TERMINAL (d)           | 26/27 (96%)  26/28 (93%)  23/23 (100%) 23/24 (96%) |                                                    |
|FIRST INCIDENCE (DAYS) |   514          506          441          442       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.200      P=0.509      P=0.063      P=0.314    |                                                    |
|INCIDENTAL TUMOR       |  P=0.426      P=0.373      P=0.039 *    P=0.451    |                                                    |
|LOGISTIC REGRESSION    |  P=0.469      P=0.351      P=0.023 *    P=0.493    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.489N                                          |                                                    |
|FISHER EXACT           |               P=0.277      P=0.046 *    P=0.607N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    8/50 (16%)   1/50 (2%)    6/50 (12%) |  9/49 (18%)   5/50 (10%)   6/50 (12%)   7/50 (14%) |
|ADJUSTED (b)           |  13.3%        25.6%         4.3%        18.4%      |  24.7%        12.7%        17.6%        23.7%      |
|TERMINAL (d)           |  2/27 (7%)    6/28 (21%)   1/23 (4%)    2/24 (8%)  |  5/30 (17%)   2/34 (6%)    6/34 (18%)   6/28 (21%) |
|FIRST INCIDENCE (DAYS) |   682          619          729 (T)      533       |   578          618          729 (T)      662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.538      P=0.210      P=0.219N     P=0.332    |  P=0.527      P=0.155N     P=0.231N     P=0.450N   |
|INCIDENTAL TUMOR       |  P=0.519N     P=0.206      P=0.177N     P=0.370    |  P=0.515N     P=0.166N     P=0.275N     P=0.393N   |
|LOGISTIC REGRESSION    |  P=0.527N     P=0.200      P=0.194N     P=0.361    |  P=0.531N     P=0.187N     P=0.268N     P=0.407N   |
|COCHRAN-ARMITAGE       |  P=0.488N                                          |  P=0.478N                                          |
|FISHER EXACT           |               P=0.178      P=0.181N     P=0.370    |               P=0.183N     P=0.274N     P=0.376N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  16
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    3/50 (6%)    1/50 (2%)    2/50 (4%)  |  1/49 (2%)    3/50 (6%)    3/50 (6%)    1/50 (2%)  |
|ADJUSTED (b)           |  11.1%        10.7%         4.3%         5.5%      |   3.3%         8.0%         8.6%         2.9%      |
|TERMINAL (d)           |  3/27 (11%)   3/28 (11%)   1/23 (4%)    0/24 (0%)  |  1/30 (3%)    2/34 (6%)    2/34 (6%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      606       |   729 (T)      626          718          668       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.377N     P=0.649N     P=0.362N     P=0.540N   |  P=0.490N     P=0.349      P=0.352      P=0.743    |
|INCIDENTAL TUMOR       |  P=0.361N     P=0.649N     P=0.362N     P=0.515N   |  P=0.463N     P=0.340      P=0.278      P=0.753    |
|LOGISTIC REGRESSION    |  P=0.352N     P=0.649N     P=0.362N     P=0.517N   |  P=0.470N     P=0.326      P=0.336      P=0.759    |
|COCHRAN-ARMITAGE       |  P=0.317N                                          |  P=0.439N                                          |
|FISHER EXACT           |               P=0.661N     P=0.309N     P=0.500N   |               P=0.316      P=0.316      P=0.747N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/50 (14%)  11/50 (22%)   2/50 (4%)    8/50 (16%) | 10/49 (20%)   8/50 (16%)   9/50 (18%)   8/50 (16%) |
|ADJUSTED (b)           |  23.7%        35.7%         8.7%        23.0%      |  27.7%        20.0%        25.7%        25.9%      |
|TERMINAL (d)           |  5/27 (19%)   9/28 (32%)   2/23 (9%)    2/24 (8%)  |  6/30 (20%)   4/34 (12%)   8/34 (24%)   6/28 (21%) |
|FIRST INCIDENCE (DAYS) |   682          619          729 (T)      533       |   578          618          718          662       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.445N     P=0.252      P=0.117N     P=0.438    |  P=0.518N     P=0.317N     P=0.409N     P=0.461N   |
|INCIDENTAL TUMOR       |  P=0.381N     P=0.248      P=0.095N     P=0.490    |  P=0.448N     P=0.345N     P=0.502N     P=0.401N   |
|LOGISTIC REGRESSION    |  P=0.383N     P=0.256      P=0.092N     P=0.482    |  P=0.464N     P=0.378N     P=0.471N     P=0.413N   |
|COCHRAN-ARMITAGE       |  P=0.330N                                          |  P=0.403N                                          |
|FISHER EXACT           |               P=0.218      P=0.080N     P=0.500    |               P=0.379N     P=0.480N     P=0.379N   |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  17
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |  0/49 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%         4.2%      |   0.0%         0.0%         0.0%         6.0%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   635          ---          ---          729 (T)   |   ---          ---          ---          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.508      P=0.495N     P=0.505N     P=0.739    |  P=0.037 *      (e)          (e)        P=0.229    |
|INCIDENTAL TUMOR       |  P=0.535      P=0.540N     P=0.540N     P=0.757    |  P=0.050 *      (e)          (e)        P=0.259    |
|LOGISTIC REGRESSION    |  P=0.536      P=0.529N     P=0.476N     P=0.762    |  P=0.042 *      (e)          (e)        P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.536                                           |  P=0.044 *                                         |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.753N   |                 (e)          (e)        P=0.253    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |  0/49 (0%)    1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   2.5%         3.4%         0.0%         4.2%      |   0.0%         2.9%         0.0%         6.0%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    1/34 (3%)    0/34 (0%)    1/28 (4%)  |
|FIRST INCIDENCE (DAYS) |   635          725          ---          729 (T)   |   ---          729 (T)      ---          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.625N     P=0.750N     P=0.505N     P=0.739    |  P=0.149      P=0.525        (e)        P=0.229    |
|INCIDENTAL TUMOR       |  P=0.583N     P=0.759      P=0.540N     P=0.757    |  P=0.171      P=0.525        (e)        P=0.259    |
|LOGISTIC REGRESSION    |  P=0.601N     P=0.759      P=0.476N     P=0.762    |  P=0.160      P=0.525        (e)        P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.588N                                          |  P=0.171                                           |
|FISHER EXACT           |               P=0.753N     P=0.500N     P=0.753N   |               P=0.505        (e)        P=0.253    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  18
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                               |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 15/50 (30%)  12/50 (24%)  14/50 (28%)  10/50 (20%) |
|ADJUSTED (b)           |                                                    |  41.9%        31.9%        34.9%        27.6%      |
|TERMINAL (d)           |                                                    | 10/30 (33%)   9/34 (26%)   9/34 (26%)   5/28 (18%) |
|FIRST INCIDENCE (DAYS) |                                                    |   574          627          372          554       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.313N     P=0.224N     P=0.394N     P=0.241N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.247N     P=0.282N     P=0.547N     P=0.176N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.239N     P=0.263N     P=0.497N     P=0.197N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.211N                                          |
|FISHER EXACT           |                                                    |               P=0.326N     P=0.500N     P=0.178N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    4/50 (8%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        10.4%         6.4%      |   0.0%         0.0%         0.0%         2.1%      |
|TERMINAL (d)           |  0/27 (0%)    0/28 (0%)    1/23 (4%)    1/24 (4%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          471          586       |   ---          ---          ---          354       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.066        (e)        P=0.060      P=0.222    |  P=0.181        (e)          (e)        P=0.492    |
|INCIDENTAL TUMOR       |  P=0.089        (e)        P=0.102      P=0.236    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.137        (e)        P=0.096      P=0.247    |  P=0.492        (e)          (e)        P=0.774    |
|COCHRAN-ARMITAGE       |  P=0.078                                           |  P=0.186                                           |
|FISHER EXACT           |                 (e)        P=0.059      P=0.247    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  19
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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)            |  2/50 (4%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.3%         6.4%         0.0%         4.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    1/28 (4%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          692          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.299N     P=0.680N     P=0.249N     P=0.539N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.269N     P=0.676N     P=0.232N     P=0.493N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.273N     P=0.692      P=0.224N     P=0.502N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.263N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.247N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    0/50 (0%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.3%         6.4%         0.0%         4.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/27 (0%)    1/28 (4%)    0/23 (0%)    1/24 (4%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          692          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.299N     P=0.680N     P=0.249N     P=0.539N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.269N     P=0.676N     P=0.232N     P=0.493N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.273N     P=0.692      P=0.224N     P=0.502N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.263N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.247N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  20
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 27/50 (54%)  26/50 (52%)  24/50 (48%)  20/50 (40%) |  9/50 (18%)  17/50 (34%)  15/50 (30%)  24/50 (48%) |
|ADJUSTED (b)           |  63.4%        64.9%        62.4%        54.5%      |  26.4%        42.8%        35.1%        56.3%      |
|TERMINAL (d)           | 12/27 (44%)  15/28 (54%)  10/23 (43%)   9/24 (38%) |  6/30 (20%)  12/34 (35%)   8/34 (24%)  10/28 (36%) |
|FIRST INCIDENCE (DAYS) |   568          549          484          442       |   575          581          485          554       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.270N     P=0.419N     P=0.531N     P=0.262N   |  P=0.003 **   P=0.116      P=0.188      P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.091N     P=0.454N     P=0.353N     P=0.116N   |  P=0.002 **   P=0.069      P=0.123      P=0.001 ** |
|LOGISTIC REGRESSION    |  P=0.084N     P=0.499N     P=0.410N     P=0.122N   |  P=0.003 **   P=0.070      P=0.120      P=0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.078N                                          |  P=0.004 **                                        |
|FISHER EXACT           |               P=0.500N     P=0.345N     P=0.115N   |               P=0.055      P=0.121      P=0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    5/50 (10%)   0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   7.4%        13.9%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/27 (7%)    2/28 (7%)    0/23 (0%)    0/24 (0%)  |  0/30 (0%)    0/34 (0%)    0/34 (0%)    0/28 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      506          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.031N*    P=0.244      P=0.274N     P=0.264N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.021N*    P=0.208      P=0.274N     P=0.264N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.022N*    P=0.210      P=0.274N     P=0.264N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.023N*                                         |    (e)                                             |
|FISHER EXACT           |               P=0.218      P=0.247N     P=0.247N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  21
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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)            | 47/50 (94%)  50/50 (100%) 50/50 (100%) 49/50 (98%) | 41/50 (82%)  44/50 (88%)  45/50 (90%)  40/50 (80%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.1%        91.6%        97.8%        90.7%      |
|TERMINAL (d)           | 27/27 (100%) 28/28 (100%) 23/23 (100%) 24/24 (100%)| 26/30 (87%)  30/34 (88%)  33/34 (97%)  24/28 (86%) |
|FIRST INCIDENCE (DAYS) |   514          506          441          442       |   517          501          372          471       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.133      P=0.517      P=0.147      P=0.214    |  P=0.359      P=0.456N     P=0.569      P=0.463    |
|INCIDENTAL TUMOR       |  P=0.056      P=0.189      P=0.087      P=0.110    |  P=0.453      P=0.379      P=0.152      P=0.502    |
|LOGISTIC REGRESSION    |  P=0.053      P=0.171      P=0.045 *    P=0.086    |  P=0.522N     P=0.420      P=0.174      P=0.591    |
|COCHRAN-ARMITAGE       |  P=0.327                                           |  P=0.334N                                          |
|FISHER EXACT           |               P=0.121      P=0.121      P=0.309    |               P=0.288      P=0.194      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/50 (68%)  34/50 (68%)  34/50 (68%)  35/50 (70%) | 21/50 (42%)  23/50 (46%)  21/50 (42%)  33/50 (66%) |
|ADJUSTED (b)           |  78.5%        80.0%        77.6%        80.0%      |  51.1%        53.1%        49.1%        69.9%      |
|TERMINAL (d)           | 18/27 (67%)  20/28 (71%)  14/23 (61%)  16/24 (67%) | 11/30 (37%)  14/34 (41%)  13/34 (38%)  14/28 (50%) |
|FIRST INCIDENCE (DAYS) |   568          506          471          305       |   380          581          485          245       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.217      P=0.463N     P=0.362      P=0.330    |  P=0.011 *    P=0.543N     P=0.455N     P=0.028 *  |
|INCIDENTAL TUMOR       |  P=0.490      P=0.541N     P=0.555      P=0.539    |  P=0.027 *    P=0.392      P=0.528      P=0.034 *  |
|LOGISTIC REGRESSION    |  P=0.491      P=0.575N     P=0.580N     P=0.523    |  P=0.016 *    P=0.401      P=0.578      P=0.017 *  |
|COCHRAN-ARMITAGE       |  P=0.446                                           |  P=0.011 *                                         |
|FISHER EXACT           |               P=0.585N     P=0.585N     P=0.500    |               P=0.420      P=0.580N     P=0.013 *  |
|=================================================================================================================================|
 
         DATE: 09/05/94                     EXPERIMENT: 05035 TEST: 03                                                 PAGE  22
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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)            | 49/50 (98%)  50/50 (100%) 50/50 (100%) 50/50 (100%)| 47/50 (94%)  46/50 (92%)  49/50 (98%)  46/50 (92%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  95.9%        93.9%       100.0%        92.0%      |
|TERMINAL (d)           | 27/27 (100%) 28/28 (100%) 23/23 (100%) 24/24 (100%)| 28/30 (93%)  31/34 (91%)  34/34 (100%) 24/28 (86%) |
|FIRST INCIDENCE (DAYS) |   514          506          441          305       |   380          501          372          245       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.148      P=0.482N     P=0.227      P=0.265    |  P=0.247      P=0.210N     P=0.425N     P=0.453    |
|INCIDENTAL TUMOR       |  P=0.267      P=0.638      P=0.318      P=0.500    |  P=0.496N     P=0.443N     P=0.264      P=0.415N   |
|LOGISTIC REGRESSION    |  P=0.095      P=0.638      P=0.247      P=0.276    |  P=0.545N     P=0.454N     P=0.305      P=0.482N   |
|COCHRAN-ARMITAGE       |  P=0.351                                           |  P=0.545N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.500N     P=0.309      P=0.500N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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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