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TDMS Study 05142-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95       
EXPERIMENT: 05142 TEST: 03                                                                                     TIME: 07:57:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B       
PATHOLOGIST: DR J. HEATH                     S. EUSTIS                                                         CAS: 75-65-0         
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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: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95       
EXPERIMENT: 05142 TEST: 03                                                                                     TIME: 07:57:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B       
PATHOLOGIST: DR J. HEATH                     S. EUSTIS                                                         CAS: 75-65-0         


                                                    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 Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial 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: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95       
EXPERIMENT: 05142 TEST: 03                                                                                     TIME: 07:57:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B       
PATHOLOGIST: DR J. HEATH                     S. EUSTIS                                                         CAS: 75-65-0         


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF T-BUTYL ALCOHOL
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
              Islets, Pancreatic            Adenoma
                                            Carcinoma or Adenoma
              Kidney: Renal Tubule          Adenoma
                                            Carcinoma or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Testes                        Adenoma
              Thymus                        Thymoma Benign
                                            Thymoma: Benign, Malignant, NOS
              Thyroid Gland: Follicular Cell
                                            Carcinoma or Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Lung                          Alveolar/Bronchiolar Adenoma
              Mammary Gland                 Carcinoma
                                            Carcinoma or Adenoma
                                            Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Uterus                        Polyp Stromal
                                            Sarcoma Stromal or Polyp Stromal
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   1
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)   7/60 (12%)   4/60 (7%)    4/60 (7%)  |  3/60 (5%)    0/60 (0%)    1/60 (2%)    2/59 (3%)  |
|ADJUSTED (b)           |  44.7%        35.0%        55.2%        14.2%      |   9.4%         0.0%         4.5%        11.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/10 (20%)   0/6 (0%)     2/4 (50%)    0/1 (0%)   |  2/28 (7%)    0/24 (0%)    1/22 (5%)    1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   588          584          637          506       |   591          ---          729 (T)      617       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.545N     P=0.442N     P=0.446N     P=0.568N   |  P=0.484      P=0.146N     P=0.384N     P=0.641    |
|INCIDENTAL TUMOR       |  P=0.106N     P=0.284N     P=0.240N     P=0.143N   |  P=0.587      P=0.141N     P=0.411N     P=0.611N   |
|LOGISTIC REGRESSION    |  P=0.188N     P=0.385N     P=0.265N     P=0.213N   |  P=0.598      P=0.131N     P=0.333N     P=0.586N   |
|COCHRAN-ARMITAGE       |  P=0.073N                                          |  P=0.562N                                          |
|FISHER EXACT           |               P=0.395N     P=0.120N     P=0.120N   |               P=0.122N     P=0.309N     P=0.508N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    1/60 (2%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    1/59 (2%)  |
|ADJUSTED (b)           |  24.9%         3.3%        26.7%         0.0%      |   0.0%         4.2%         0.0%         1.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  2/10 (20%)   0/6 (0%)     1/4 (25%)    0/1 (0%)   |  0/28 (0%)    1/24 (4%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   588          624          512          ---       |   ---          729 (T)      ---          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.182N     P=0.223N     P=0.586N     P=0.251N   |  P=0.324      P=0.469        (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.107N     P=0.272N     P=0.461N     P=0.154N   |  P=0.324      P=0.469        (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.081N     P=0.177N     P=0.435N     P=0.119N   |  P=0.407      P=0.469        (e)        P=0.517    |
|COCHRAN-ARMITAGE       |  P=0.053N                                          |  P=0.401                                           |
|FISHER EXACT           |               P=0.182N     P=0.340N     P=0.059N   |               P=0.500        (e)        P=0.496    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   2
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 12/60 (20%)   7/60 (12%)   6/60 (10%)   4/60 (7%)  |  3/60 (5%)    1/60 (2%)    2/60 (3%)    3/59 (5%)  |
|ADJUSTED (b)           |  60.0%        35.0%        78.1%        14.2%      |   9.4%         4.2%         6.9%        12.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  4/10 (40%)   0/6 (0%)     3/4 (75%)    0/1 (0%)   |  2/28 (7%)    1/24 (4%)    1/22 (5%)    1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   588          584          512          506       |   591          729 (T)      565          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.436N     P=0.231N     P=0.496N     P=0.431N   |  P=0.292      P=0.355N     P=0.587N     P=0.458    |
|INCIDENTAL TUMOR       |  P=0.064N     P=0.122N     P=0.241N     P=0.073N   |  P=0.411      P=0.348N     P=0.638N     P=0.575    |
|LOGISTIC REGRESSION    |  P=0.087N     P=0.142N     P=0.250N     P=0.084N   |  P=0.441      P=0.331N     P=0.526N     P=0.637    |
|COCHRAN-ARMITAGE       |  P=0.024N*                                         |  P=0.469                                           |
|FISHER EXACT           |               P=0.159N     P=0.100N     P=0.029N*  |               P=0.309N     P=0.500N     P=0.652    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    1/60 (2%)    2/59 (3%)  |  4/59 (7%)    6/60 (10%)   4/60 (7%)    2/60 (3%)  |
|ADJUSTED (b)           |  13.9%         2.8%         3.1%       100.0%      |  13.1%        19.4%        18.2%         7.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     0/4 (0%)     1/1 (100%) |  2/27 (7%)    3/24 (13%)   4/22 (18%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   636          596          582          575       |   645          457 (I)      729 (T)      597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.297      P=0.531N     P=0.628N     P=0.308    |  P=0.450N     P=0.313      P=0.550      P=0.571N   |
|INCIDENTAL TUMOR       |  P=0.423      P=0.589N     P=0.602N     P=0.397    |  P=0.247N     P=0.334      P=0.634      P=0.276N   |
|LOGISTIC REGRESSION    |  P=0.456      P=0.498N     P=0.573N     P=0.509    |  P=0.241N     P=0.353      P=0.610      P=0.403N   |
|COCHRAN-ARMITAGE       |  P=0.549                                           |  P=0.185N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.684    |               P=0.382      P=0.632N     P=0.332N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   3
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    3/60 (5%)    1/59 (2%)  |  3/59 (5%)    2/60 (3%)    6/60 (10%)   4/60 (7%)  |
|ADJUSTED (b)           |   2.2%         7.0%        13.0%         1.7%      |  10.6%         6.6%        24.4%        21.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  2/27 (7%)    1/24 (4%)    4/22 (18%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   553          348          589          262       |   723          591          699          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.576N     P=0.331      P=0.264      P=0.758N   |  P=0.073      P=0.548N     P=0.162      P=0.192    |
|INCIDENTAL TUMOR       |  P=0.409N     P=0.270      P=0.303      P=0.736N   |  P=0.264      P=0.532N     P=0.257      P=0.492    |
|LOGISTIC REGRESSION    |  P=0.498N     P=0.273      P=0.289      P=0.723    |  P=0.181      P=0.523N     P=0.197      P=0.342    |
|COCHRAN-ARMITAGE       |  P=0.507N                                          |  P=0.317                                           |
|FISHER EXACT           |               P=0.309      P=0.309      P=0.748    |               P=0.492N     P=0.254      P=0.509    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    4/60 (7%)    3/59 (5%)  |  7/59 (12%)   8/60 (13%)  10/60 (17%)   6/60 (10%) |
|ADJUSTED (b)           |  15.8%         7.0%        15.7%       100.0%      |  22.8%        25.2%        41.2%        27.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     0/4 (0%)     1/1 (100%) |  4/27 (15%)   4/24 (17%)   8/22 (36%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   553          348          582          262       |   645          457 (I)      699          597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.338      P=0.647      P=0.379      P=0.355    |  P=0.211      P=0.417      P=0.176      P=0.321    |
|INCIDENTAL TUMOR       |  P=0.531      P=0.581      P=0.432      P=0.443    |  P=0.534N     P=0.448      P=0.297      P=0.463N   |
|LOGISTIC REGRESSION    |  P=0.557      P=0.657      P=0.445      P=0.656    |  P=0.523      P=0.470      P=0.237      P=0.583    |
|COCHRAN-ARMITAGE       |  P=0.548                                           |  P=0.424N                                          |
|FISHER EXACT           |               P=0.660N     P=0.500      P=0.652    |               P=0.514      P=0.314      P=0.487N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   4
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/60 (25%)  15/59 (25%)   7/59 (12%)   6/59 (10%) |  1/60 (2%)    1/60 (2%)    4/58 (7%)    1/60 (2%)  |
|ADJUSTED (b)           |  68.0%        66.3%        51.4%        29.0%      |   3.4%         4.0%        18.0%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/10 (40%)   1/6 (17%)    1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    3/21 (14%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   604          520          556          555       |   723          727          724          666       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.438N     P=0.477      P=0.392N     P=0.568N   |  P=0.261      P=0.735      P=0.114      P=0.637    |
|INCIDENTAL TUMOR       |  P=0.012N*    P=0.400N     P=0.109N     P=0.044N*  |  P=0.537      P=0.769      P=0.187      P=0.640N   |
|LOGISTIC REGRESSION    |  P=0.051N     P=0.574N     P=0.144N     P=0.131N   |  P=0.351      P=0.742      P=0.120      P=0.710    |
|COCHRAN-ARMITAGE       |  P=0.009N**                                        |  P=0.524                                           |
|FISHER EXACT           |               P=0.563      P=0.053N     P=0.029N*  |               P=0.752N     P=0.172      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/59 (0%)    2/59 (3%)    0/59 (0%)  |  1/60 (2%)    0/60 (0%)    0/58 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.9%         0.0%         6.3%         0.0%      |   3.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     0/4 (0%)     0/1 (0%)   |  1/28 (4%)    0/24 (0%)    0/21 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   636          ---          542          ---       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.407N     P=0.285N     P=0.582      P=0.499N   |  P=0.398N     P=0.531N     P=0.557N     P=0.669N   |
|INCIDENTAL TUMOR       |  P=0.289N     P=0.312N     P=0.698N     P=0.399N   |  P=0.398N     P=0.531N     P=0.557N     P=0.669N   |
|LOGISTIC REGRESSION    |  P=0.288N     P=0.240N     P=0.649      P=0.392N   |  P=0.398N     P=0.531N     P=0.557N     P=0.669N   |
|COCHRAN-ARMITAGE       |  P=0.251N                                          |  P=0.307N                                          |
|FISHER EXACT           |               P=0.252N     P=0.684      P=0.252N   |               P=0.500N     P=0.508N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   5
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/60 (28%)  15/59 (25%)   9/59 (15%)   6/59 (10%) |  2/60 (3%)    1/60 (2%)    4/58 (7%)    1/60 (2%)  |
|ADJUSTED (b)           |  74.5%        66.3%        54.5%        29.0%      |   6.9%         4.0%        18.0%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  5/10 (50%)   1/6 (17%)    1/4 (25%)    0/1 (0%)   |  1/28 (4%)    0/24 (0%)    3/21 (14%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   604          520          542          555       |   723          727          724          666       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.368N     P=0.538N     P=0.450N     P=0.466N   |  P=0.404      P=0.543N     P=0.226      P=0.714N   |
|INCIDENTAL TUMOR       |  P=0.007N**   P=0.264N     P=0.125N     P=0.023N*  |  P=0.533N     P=0.518N     P=0.327      P=0.469N   |
|LOGISTIC REGRESSION    |  P=0.028N*    P=0.387N     P=0.167N     P=0.066N   |  P=0.509      P=0.535N     P=0.241      P=0.622N   |
|COCHRAN-ARMITAGE       |  P=0.004N**                                        |  P=0.502N                                          |
|FISHER EXACT           |               P=0.440N     P=0.066N     P=0.011N*  |               P=0.500N     P=0.324      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    4/60 (7%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  10.0%        40.0%        34.9%        24.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   2/6 (33%)    0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      708          605          566       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.018 *    P=0.160      P=0.061      P=0.091    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.131      P=0.206      P=0.127      P=0.206    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.094      P=0.188      P=0.093      P=0.215    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.283                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309      P=0.182      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   6
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    4/60 (7%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  10.0%        40.0%        34.9%        24.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   2/6 (33%)    0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      708          605          566       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.018 *    P=0.160      P=0.061      P=0.091    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.131      P=0.206      P=0.127      P=0.206    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.094      P=0.188      P=0.093      P=0.215    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.283                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309      P=0.182      P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |  10.0%         0.0%        25.0%         0.0%      |   0.0%         0.0%         4.5%        10.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    1/22 (5%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      ---       |   ---          ---          729 (T)      605       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.691      P=0.602N     P=0.546      P=0.923N   |  P=0.029 *      (e)        P=0.452      P=0.159    |
|INCIDENTAL TUMOR       |  P=0.691      P=0.602N     P=0.546      P=0.923N   |  P=0.094        (e)        P=0.452      P=0.377    |
|LOGISTIC REGRESSION    |  P=0.691      P=0.602N     P=0.546      P=0.923N   |  P=0.052        (e)        P=0.452      P=0.211    |
|COCHRAN-ARMITAGE       |  P=0.405N                                          |  P=0.070                                           |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.500N   |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   7
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    1/60 (2%)    2/60 (3%)    2/60 (3%)  |
|ADJUSTED (b)           |  10.0%         0.0%        25.0%        12.5%      |   0.0%         4.2%         6.3%        10.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     1/4 (25%)    0/1 (0%)   |  0/28 (0%)    1/24 (4%)    1/22 (5%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          729 (T)      669       |   ---          729 (T)      457 (I)      605       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.154      P=0.602N     P=0.546      P=0.426    |  P=0.076      P=0.469      P=0.213      P=0.159    |
|INCIDENTAL TUMOR       |  P=0.223      P=0.602N     P=0.546      P=0.591    |  P=0.155      P=0.469      P=0.213      P=0.377    |
|LOGISTIC REGRESSION    |  P=0.199      P=0.602N     P=0.546      P=0.528    |  P=0.149      P=0.469      P=0.246      P=0.211    |
|COCHRAN-ARMITAGE       |  P=0.539                                           |  P=0.160                                           |
|FISHER EXACT           |               P=0.500N     P=0.752N     P=0.752N   |               P=0.500      P=0.248      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  2/60 (3%)    1/60 (2%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   7.1%         4.2%         6.8%         3.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  2/28 (7%)    1/24 (4%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   729 (T)      729 (T)      694          631       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.578      P=0.554N     P=0.646      P=0.720N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.456N     P=0.554N     P=0.645N     P=0.620N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.538N     P=0.554N     P=0.663      P=0.594N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.444N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.691N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   8
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  6/60 (10%)   5/60 (8%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  18.9%        18.4%         4.2%         3.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  3/28 (11%)   3/24 (13%)   0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   625          646          708          636       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.083N     P=0.588N     P=0.098N     P=0.226N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.015N*    P=0.560N     P=0.046N*    P=0.052N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.034N*    P=0.559N     P=0.072N     P=0.102N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.019N*                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500N     P=0.057N     P=0.057N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  8/60 (13%)   5/60 (8%)    3/60 (5%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  25.4%        18.4%        10.7%         7.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  5/28 (18%)   3/24 (13%)   0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   625          646          694          631       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.145N     P=0.371N     P=0.169N     P=0.255N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.020N*    P=0.338N     P=0.067N     P=0.058N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.013N*    P=0.330N     P=0.126N     P=0.096N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.028N*                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.279N     P=0.102N     P=0.047N*  |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE   9
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  | 14/60 (23%)  15/60 (25%)  11/60 (18%)   8/60 (13%) |
|ADJUSTED (b)           |   8.3%        25.0%         2.3%         0.0%      |  34.5%        47.5%        40.8%        32.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    0/4 (0%)     0/1 (0%)   |  4/28 (14%)   9/24 (38%)   7/22 (32%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          708          525          ---       |   457 (I)      457 (I)      652          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.613N     P=0.375      P=0.635      P=0.944N   |  P=0.432N     P=0.375      P=0.477N     P=0.447N   |
|INCIDENTAL TUMOR       |  P=0.326N     P=0.556      P=0.647N     P=0.467N   |  P=0.045N*    P=0.451      P=0.321N     P=0.019N*  |
|LOGISTIC REGRESSION    |  P=0.377N     P=0.424      P=0.743      P=0.856N   |  P=0.106N     P=0.450      P=0.390N     P=0.151N   |
|COCHRAN-ARMITAGE       |  P=0.248N                                          |  P=0.063N                                          |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.500N   |               P=0.500      P=0.327N     P=0.119N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  | 16/60 (27%)  15/60 (25%)  11/60 (18%)   9/60 (15%) |
|ADJUSTED (b)           |   8.3%        25.0%         2.3%         0.0%      |  40.0%        47.5%        40.8%        35.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    0/4 (0%)     0/1 (0%)   |  6/28 (21%)   9/24 (38%)   7/22 (32%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          708          525          ---       |   457 (I)      457 (I)      652          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.613N     P=0.375      P=0.635      P=0.944N   |  P=0.420N     P=0.518      P=0.338N     P=0.445N   |
|INCIDENTAL TUMOR       |  P=0.326N     P=0.556      P=0.647N     P=0.467N   |  P=0.040N*    P=0.560N     P=0.197N     P=0.019N*  |
|LOGISTIC REGRESSION    |  P=0.377N     P=0.424      P=0.743      P=0.856N   |  P=0.091N     P=0.559N     P=0.242N     P=0.123N   |
|COCHRAN-ARMITAGE       |  P=0.248N                                          |  P=0.052N                                          |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.500N   |               P=0.500N     P=0.191N     P=0.088N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  10
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/60 (3%)    1/60 (2%)    0/60 (0%)  | 19/60 (32%)  17/60 (28%)  12/60 (20%)  10/60 (17%) |
|ADJUSTED (b)           |   8.3%        25.0%         2.3%         0.0%      |  48.2%        52.6%        43.3%        37.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    0/4 (0%)     0/1 (0%)   |  9/28 (32%)  10/24 (42%)   7/22 (32%)   0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   720          708          525          ---       |   457 (I)      457 (I)      652          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.613N     P=0.375      P=0.635      P=0.944N   |  P=0.346N     P=0.564      P=0.241N     P=0.398N   |
|INCIDENTAL TUMOR       |  P=0.326N     P=0.556      P=0.647N     P=0.467N   |  P=0.018N*    P=0.503N     P=0.107N     P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.377N     P=0.424      P=0.743      P=0.856N   |  P=0.048N*    P=0.494N     P=0.142N     P=0.072N   |
|COCHRAN-ARMITAGE       |  P=0.248N                                          |  P=0.023N*                                         |
|FISHER EXACT           |               P=0.500      P=0.752N     P=0.500N   |               P=0.421N     P=0.105N     P=0.043N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Papilloma Squamous or Papilloma                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |  10.0%         0.0%         0.0%         3.3%      |   0.0%         4.0%         0.0%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          594       |   ---          727          ---          597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.394      P=0.602N     P=0.682N     P=0.541    |  P=0.098      P=0.477        (e)        P=0.216    |
|INCIDENTAL TUMOR       |  P=0.455      P=0.602N     P=0.682N     P=0.606    |  P=0.285      P=0.500        (e)        P=0.389    |
|LOGISTIC REGRESSION    |  P=0.505      P=0.602N     P=0.682N     P=0.674    |  P=0.132      P=0.480        (e)        P=0.241    |
|COCHRAN-ARMITAGE       |  P=0.595                                           |  P=0.140                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.752N   |               P=0.500        (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  11
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  0/60 (0%)    2/60 (3%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |  10.0%         0.0%         0.0%         3.3%      |   0.0%         7.4%         3.0%         5.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          594       |   ---          703          651          597       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.394      P=0.602N     P=0.682N     P=0.541    |  P=0.163      P=0.224      P=0.506      P=0.216    |
|INCIDENTAL TUMOR       |  P=0.455      P=0.602N     P=0.682N     P=0.606    |  P=0.453      P=0.231      P=0.607      P=0.389    |
|LOGISTIC REGRESSION    |  P=0.505      P=0.602N     P=0.682N     P=0.674    |  P=0.224      P=0.217      P=0.493      P=0.241    |
|COCHRAN-ARMITAGE       |  P=0.595                                           |  P=0.246                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.752N   |               P=0.248      P=0.500      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    6/59 (10%)   1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  22.9%        63.3%        16.7%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   3/6 (50%)    0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   694          693          685          575       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.456      P=0.111      P=0.667N     P=0.683    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.253N     P=0.250      P=0.381N     P=0.395N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.434N     P=0.156      P=0.571N     P=0.524N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.095N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.237      P=0.309N     P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  12
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    7/59 (12%)   2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  22.9%        64.8%        18.9%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/10 (10%)   3/6 (50%)    0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   694          639          551          575       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.488      P=0.073      P=0.527      P=0.683    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.219N     P=0.156      P=0.580N     P=0.395N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.330N     P=0.108      P=0.652N     P=0.524N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.096N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.154      P=0.500N     P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/59 (66%)  38/60 (63%)  35/59 (59%)  27/58 (47%) | 33/60 (55%)  32/60 (53%)  28/59 (47%)  30/59 (51%) |
|ADJUSTED (b)           |  93.2%        96.3%       100.0%        93.5%      |  79.3%        80.6%        74.2%        92.2%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   5/10 (50%)   4/10 (40%)   4/9 (44%)  |  3/10 (30%)   3/10 (30%)   2/10 (20%)   3/10 (30%) |
|TERMINAL (d)           |  7/9 (78%)    5/6 (83%)    4/4 (100%)   0/1 (0%)   | 20/28 (71%)  17/24 (71%)  13/22 (59%)  10/12 (83%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      395          398          456 (I)   |   457 (I)      424          377          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.174      P=0.520      P=0.190      P=0.337    |  P=0.035 *    P=0.385      P=0.559N     P=0.031 *  |
|INCIDENTAL TUMOR       |  P=0.027N*    P=0.436N     P=0.367N     P=0.033N*  |  P=0.513      P=0.534      P=0.305N     P=0.437    |
|LOGISTIC REGRESSION    |  P=0.021N*    P=0.416N     P=0.353N     P=0.033N*  |  P=0.439N     P=0.547      P=0.350N     P=0.538N   |
|COCHRAN-ARMITAGE       |  P=0.014N*                                         |  P=0.332N                                          |
|FISHER EXACT           |               P=0.451N     P=0.284N     P=0.026N*  |               P=0.500N     P=0.261N     P=0.394N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  13
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    0/60 (0%)    0/59 (0%)    0/58 (0%)  |  2/60 (3%)    1/60 (2%)    1/59 (2%)    1/59 (2%)  |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         0.0%      |   5.0%         3.0%         3.8%         2.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/9 (0%)   |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/9 (0%)     0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   645          ---          ---          ---       |   457 (I)      624          703          555       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.364N     P=0.473N     P=0.567N     P=0.581N   |  P=0.480N     P=0.524N     P=0.520N     P=0.562N   |
|INCIDENTAL TUMOR       |  P=0.305N     P=0.402N     P=0.500N     P=0.467N   |  P=0.254N     P=0.500N     P=0.376N     P=0.366N   |
|LOGISTIC REGRESSION    |  P=0.335N     P=0.493N     P=0.536N     P=0.554N   |  P=0.411N     P=0.488N     P=0.504N     P=0.489N   |
|COCHRAN-ARMITAGE       |  P=0.308N                                          |  P=0.416N                                          |
|FISHER EXACT           |               P=0.496N     P=0.500N     P=0.504N   |               P=0.500N     P=0.506N     P=0.506N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 39/59 (66%)  38/60 (63%)  35/59 (59%)  27/58 (47%) | 35/60 (58%)  33/60 (55%)  29/59 (49%)  31/59 (53%) |
|ADJUSTED (b)           |  93.2%        96.3%       100.0%        93.5%      |  80.4%        81.2%        75.2%        92.4%      |
|INTERIM SACRIFICE 1 (c)|  6/10 (60%)   5/10 (50%)   4/10 (40%)   4/9 (44%)  |  4/10 (40%)   3/10 (30%)   2/10 (20%)   3/10 (30%) |
|TERMINAL (d)           |  7/9 (78%)    5/6 (83%)    4/4 (100%)   0/1 (0%)   | 20/28 (71%)  17/24 (71%)  13/22 (59%)  10/12 (83%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      395          398          456 (I)   |   457 (I)      424          377          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.174      P=0.520      P=0.190      P=0.337    |  P=0.047 *    P=0.444      P=0.501N     P=0.045 *  |
|INCIDENTAL TUMOR       |  P=0.027N*    P=0.436N     P=0.367N     P=0.033N*  |  P=0.439N     P=0.543N     P=0.208N     P=0.565    |
|LOGISTIC REGRESSION    |  P=0.021N*    P=0.416N     P=0.353N     P=0.033N*  |  P=0.371N     P=0.527N     P=0.283N     P=0.443N   |
|COCHRAN-ARMITAGE       |  P=0.014N*                                         |  P=0.279N                                          |
|FISHER EXACT           |               P=0.451N     P=0.284N     P=0.026N*  |               P=0.427N     P=0.206N     P=0.326N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  14
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.0%         0.0%      |   0.0%         0.0%         0.0%         2.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          556          ---       |   ---          ---          ---          576       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.559        (e)        P=0.221        (e)      |  P=0.207        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.653        (e)        P=0.237        (e)      |  P=0.310        (e)          (e)        P=0.630    |
|LOGISTIC REGRESSION    |  P=0.592        (e)        P=0.234        (e)      |  P=0.201        (e)          (e)        P=0.510    |
|COCHRAN-ARMITAGE       |  P=0.595                                           |  P=0.199                                           |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    5/60 (8%)    6/60 (10%)   3/60 (5%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |  14.1%        32.0%        43.4%        18.4%      |   0.0%         0.0%         2.9%         6.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   588          591          456 (I)      555       |   ---          ---          645          576       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.224      P=0.328      P=0.109      P=0.414    |  P=0.051        (e)        P=0.494      P=0.199    |
|INCIDENTAL TUMOR       |  P=0.520N     P=0.342      P=0.200      P=0.554N   |  P=0.157        (e)        P=0.607      P=0.377    |
|LOGISTIC REGRESSION    |  P=0.511      P=0.359      P=0.195      P=0.607    |  P=0.069        (e)        P=0.494      P=0.237    |
|COCHRAN-ARMITAGE       |  P=0.517N                                          |  P=0.070                                           |
|FISHER EXACT           |               P=0.359      P=0.245      P=0.660N   |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  15
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.7%        17.3%         2.2%        20.0%      |   0.0%         4.2%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    1/24 (4%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   692          584          484          679       |   ---          729 (T)      562          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.477      P=0.277      P=0.641      P=0.403    |  P=0.672N     P=0.469      P=0.486        (e)      |
|INCIDENTAL TUMOR       |  P=0.398N     P=0.369      P=0.647N     P=0.727N   |  P=0.588N     P=0.469      P=0.419        (e)      |
|LOGISTIC REGRESSION    |  P=0.505N     P=0.307      P=0.761      P=0.597    |  P=0.604N     P=0.469      P=0.518        (e)      |
|COCHRAN-ARMITAGE       |  P=0.444N                                          |  P=0.595N                                          |
|FISHER EXACT           |               P=0.309      P=0.752N     P=0.752N   |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    4/60 (7%)    2/60 (3%)    2/60 (3%)  |  2/60 (3%)    4/60 (7%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  15.3%        19.2%         6.3%        22.0%      |   7.1%        14.9%         2.4%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  2/28 (7%)    3/24 (13%)   0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   553          562          484          566       |   729 (T)      610          562          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546      P=0.466      P=0.662      P=0.502    |  P=0.181N     P=0.277      P=0.564N     P=0.438N   |
|INCIDENTAL TUMOR       |  P=0.242N     P=0.572      P=0.408N     P=0.408N   |  P=0.132N     P=0.279      P=0.602N     P=0.438N   |
|LOGISTIC REGRESSION    |  P=0.363N     P=0.504      P=0.526N     P=0.601N   |  P=0.111N     P=0.296      P=0.521N     P=0.438N   |
|COCHRAN-ARMITAGE       |  P=0.319N                                          |  P=0.087N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.340      P=0.500N     P=0.248N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  16
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    1/60 (2%)    1/60 (2%)    1/60 (2%)  |  2/60 (3%)    3/60 (5%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   9.2%         2.3%         4.2%         2.4%      |   7.1%        10.8%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  2/28 (7%)    2/24 (8%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   553          562          623          566       |   729 (T)      610          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.539N     P=0.512N     P=0.639N     P=0.679N   |  P=0.146N     P=0.441      P=0.292N     P=0.438N   |
|INCIDENTAL TUMOR       |  P=0.333N     P=0.475N     P=0.500N     P=0.422N   |  P=0.121N     P=0.444      P=0.292N     P=0.438N   |
|LOGISTIC REGRESSION    |  P=0.423N     P=0.499N     P=0.536N     P=0.520N   |  P=0.100N     P=0.462      P=0.292N     P=0.438N   |
|COCHRAN-ARMITAGE       |  P=0.409N                                          |  P=0.073N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.500      P=0.248N     P=0.248N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%        19.6%        29.2%         2.3%      |   0.0%         0.0%         2.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          626          638          555       |   ---          ---          645          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.192      P=0.199      P=0.132      P=0.514    |  P=0.658        (e)        P=0.494        (e)      |
|INCIDENTAL TUMOR       |  P=0.310      P=0.172      P=0.145      P=0.551    |  P=0.734N       (e)        P=0.607        (e)      |
|LOGISTIC REGRESSION    |  P=0.338      P=0.234      P=0.143      P=0.504    |  P=0.690        (e)        P=0.494        (e)      |
|COCHRAN-ARMITAGE       |  P=0.470                                           |  P=0.694                                           |
|FISHER EXACT           |               P=0.248      P=0.248      P=0.500    |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  17
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    3/60 (5%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  14.1%        15.4%        14.1%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   588          591          456 (I)      575       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.426N     P=0.648      P=0.676N     P=0.524N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.150N     P=0.631N     P=0.500N     P=0.227N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.227N     P=0.660N     P=0.529N     P=0.355N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.194N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.660N     P=0.500N     P=0.309N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    5/60 (8%)    4/60 (7%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |
|ADJUSTED (b)           |  14.1%        32.0%        39.1%        18.4%      |   0.0%         0.0%         2.9%         4.5%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   588          591          456 (I)      555       |   ---          ---          645          667       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.249      P=0.328      P=0.278      P=0.414    |  P=0.175        (e)        P=0.494      P=0.425    |
|INCIDENTAL TUMOR       |  P=0.511N     P=0.342      P=0.434      P=0.554N   |  P=0.341        (e)        P=0.607      P=0.607    |
|LOGISTIC REGRESSION    |  P=0.544      P=0.359      P=0.427      P=0.607    |  P=0.224        (e)        P=0.494      P=0.477    |
|COCHRAN-ARMITAGE       |  P=0.482N                                          |  P=0.236                                           |
|FISHER EXACT           |               P=0.359      P=0.500      P=0.660N   |                 (e)        P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  18
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    5/60 (8%)    4/60 (7%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |  14.1%        32.0%        39.1%         4.8%      |   0.0%         0.0%         2.9%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    1/6 (17%)    1/4 (25%)    0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   588          591          456 (I)      555       |   ---          ---          645          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.442      P=0.328      P=0.278      P=0.674    |  P=0.658        (e)        P=0.494        (e)      |
|INCIDENTAL TUMOR       |  P=0.345N     P=0.342      P=0.434      P=0.392N   |  P=0.734N       (e)        P=0.607        (e)      |
|LOGISTIC REGRESSION    |  P=0.418N     P=0.359      P=0.427      P=0.537N   |  P=0.690        (e)        P=0.494        (e)      |
|COCHRAN-ARMITAGE       |  P=0.321N                                          |  P=0.694                                           |
|FISHER EXACT           |               P=0.359      P=0.500      P=0.500N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 38/60 (63%)  34/60 (57%)  39/60 (65%)  40/60 (67%) |                                                    |
|ADJUSTED (b)           |  96.7%       100.0%        96.7%       100.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   3/10 (30%)   8/10 (80%)   7/10 (70%) |                                                    |
|TERMINAL (d)           |  9/10 (90%)   6/6 (100%)   3/4 (75%)    1/1 (100%) |                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      456 (I)      456 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.492N     P=0.048 *    P=0.004 ** |                                                    |
|INCIDENTAL TUMOR       |  P=0.120      P=0.323N     P=0.333      P=0.257    |                                                    |
|LOGISTIC REGRESSION    |  P=0.154      P=0.252N     P=0.379      P=0.319    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.271                                           |                                                    |
|FISHER EXACT           |               P=0.288N     P=0.500      P=0.424    |                                                    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  19
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma Benign                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/54 (2%)    0/59 (0%)    0/57 (0%)    2/56 (4%)  |  0/58 (0%)    0/57 (0%)    0/59 (0%)    0/58 (0%)  |
|ADJUSTED (b)           |  11.1%         0.0%         0.0%       100.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/9 (0%)     0/10 (0%)    0/9 (0%)     1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/9 (11%)    0/5 (0%)     0/4 (0%)     1/1 (100%) |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          456 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.047 *    P=0.617N     P=0.662N     P=0.106    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.047 *    P=0.617N     P=0.662N     P=0.106    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.199      P=0.617N     P=0.662N     P=0.444    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.246                                           |    (e)                                             |
|FISHER EXACT           |               P=0.478N     P=0.486N     P=0.514    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Thymoma: Benign, Malignant, NOS                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/54 (2%)    1/59 (2%)    0/57 (0%)    3/56 (5%)  |  0/58 (0%)    0/57 (0%)    0/59 (0%)    0/58 (0%)  |
|ADJUSTED (b)           |  11.1%         5.9%         0.0%       100.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/9 (0%)     0/10 (0%)    0/9 (0%)     1/9 (11%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/9 (11%)    0/5 (0%)     0/4 (0%)     1/1 (100%) |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      673          ---          274       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.024 *    P=0.705      P=0.662N     P=0.055    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.048 *    P=0.761N     P=0.662N     P=0.055    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.164      P=0.762      P=0.662N     P=0.321    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.160                                           |    (e)                                             |
|FISHER EXACT           |               P=0.730N     P=0.486N     P=0.323    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  20
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    5/59 (8%)    1/60 (2%)    5/60 (8%)  |  8/59 (14%)   4/60 (7%)    6/60 (10%)   9/60 (15%) |
|ADJUSTED (b)           |  34.2%        38.0%         4.8%        22.6%      |  24.8%        12.0%        20.1%        38.2%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  1/9 (11%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/10 (30%)   2/6 (33%)    0/4 (0%)     0/1 (0%)   |  6/28 (21%)   2/24 (8%)    2/22 (9%)    1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      637          456 (I)   |   457 (I)      430          575          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.223      P=0.485      P=0.232N     P=0.206    |  P=0.069      P=0.242N     P=0.510N     P=0.125    |
|INCIDENTAL TUMOR       |  P=0.410      P=0.438      P=0.222N     P=0.376    |  P=0.341      P=0.189N     P=0.445N     P=0.486    |
|LOGISTIC REGRESSION    |  P=0.561      P=0.628N     P=0.155N     P=0.551    |  P=0.239      P=0.191N     P=0.434N     P=0.375    |
|COCHRAN-ARMITAGE       |  P=0.497N                                          |  P=0.312                                           |
|FISHER EXACT           |               P=0.618      P=0.103N     P=0.628N   |               P=0.173N     P=0.376N     P=0.515    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    2/59 (3%)    0/60 (0%)    1/60 (2%)  |  1/59 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.2%         7.4%         0.0%         2.3%      |   3.6%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  1/28 (4%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   603          629          ---          555       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.591N     P=0.533      P=0.528N     P=0.731    |  P=0.395N     P=0.531N     P=0.548N     P=0.669N   |
|INCIDENTAL TUMOR       |  P=0.407N     P=0.453      P=0.500N     P=0.704N   |  P=0.395N     P=0.531N     P=0.548N     P=0.669N   |
|LOGISTIC REGRESSION    |  P=0.516N     P=0.500      P=0.508N     P=0.762N   |  P=0.395N     P=0.531N     P=0.548N     P=0.669N   |
|COCHRAN-ARMITAGE       |  P=0.498N                                          |  P=0.304N                                          |
|FISHER EXACT           |               P=0.494      P=0.500N     P=0.752N   |               P=0.496N     P=0.496N     P=0.496N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  21
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/60 (10%)   7/59 (12%)   1/60 (2%)    6/60 (10%) |  9/59 (15%)   4/60 (7%)    6/60 (10%)   9/60 (15%) |
|ADJUSTED (b)           |  36.3%        42.6%         4.8%        24.4%      |  28.3%        12.0%        20.1%        38.2%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |  1/9 (11%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/10 (30%)   2/6 (33%)    0/4 (0%)     0/1 (0%)   |  7/28 (25%)   2/24 (8%)    2/22 (9%)    1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      637          456 (I)   |   457 (I)      430          575          610       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.271      P=0.387      P=0.148N     P=0.219    |  P=0.101      P=0.171N     P=0.414N     P=0.165    |
|INCIDENTAL TUMOR       |  P=0.533      P=0.306      P=0.133N     P=0.420    |  P=0.414      P=0.130N     P=0.351N     P=0.551    |
|LOGISTIC REGRESSION    |  P=0.515N     P=0.502      P=0.089N     P=0.556    |  P=0.317      P=0.130N     P=0.335N     P=0.462    |
|COCHRAN-ARMITAGE       |  P=0.433N                                          |  P=0.403                                           |
|FISHER EXACT           |               P=0.487      P=0.057N     P=0.619N   |               P=0.113N     P=0.279N     P=0.585N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |  1/59 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   5.9%         0.0%         0.0%         0.0%      |   3.6%         0.0%         4.5%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  1/28 (4%)    0/24 (0%)    1/22 (5%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   573          ---          ---          ---       |   729 (T)      ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.132N     P=0.224N     P=0.268N     P=0.274N   |  P=0.565N     P=0.531N     P=0.708      P=0.669N   |
|INCIDENTAL TUMOR       |  P=0.095N     P=0.267N     P=0.237N     P=0.183N   |  P=0.565N     P=0.531N     P=0.708      P=0.669N   |
|LOGISTIC REGRESSION    |  P=0.115N     P=0.243N     P=0.239N     P=0.239N   |  P=0.565N     P=0.531N     P=0.708      P=0.669N   |
|COCHRAN-ARMITAGE       |  P=0.115N                                          |  P=0.402N                                          |
|FISHER EXACT           |               P=0.252N     P=0.248N     P=0.248N   |               P=0.496N     P=0.748N     P=0.496N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  22
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |  1/59 (2%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.4%         0.0%         0.0%         0.0%      |   3.0%         0.0%         4.5%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    1/22 (5%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   623          ---          ---          ---       |   650          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.141N     P=0.206N     P=0.249N     P=0.321N   |  P=0.510N     P=0.526N     P=0.734      P=0.564N   |
|INCIDENTAL TUMOR       |  P=0.095N     P=0.267N     P=0.237N     P=0.183N   |  P=0.414N     P=0.500N     P=0.732N     P=0.393N   |
|LOGISTIC REGRESSION    |  P=0.127N     P=0.237N     P=0.263N     P=0.271N   |  P=0.440N     P=0.503N     P=0.747      P=0.509N   |
|COCHRAN-ARMITAGE       |  P=0.115N                                          |  P=0.402N                                          |
|FISHER EXACT           |               P=0.252N     P=0.248N     P=0.248N   |               P=0.496N     P=0.748N     P=0.496N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |  2/59 (3%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.7%         0.0%         0.0%         0.0%      |   6.5%         0.0%         9.1%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/9 (0%)     0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  1/28 (4%)    0/24 (0%)    2/22 (9%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   573          ---          ---          ---       |   650          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.028N*    P=0.053N     P=0.078N     P=0.104N   |  P=0.403N     P=0.271N     P=0.628      P=0.371N   |
|INCIDENTAL TUMOR       |  P=0.014N*    P=0.078N     P=0.061N     P=0.034N*  |  P=0.337N     P=0.257N     P=0.679      P=0.258N   |
|LOGISTIC REGRESSION    |  P=0.022N*    P=0.064N     P=0.069N     P=0.070N   |  P=0.317N     P=0.251N     P=0.664      P=0.282N   |
|COCHRAN-ARMITAGE       |  P=0.020N*                                         |  P=0.244N                                          |
|FISHER EXACT           |               P=0.061N     P=0.059N     P=0.059N   |               P=0.244N     P=0.684N     P=0.244N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  23
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 14/60 (23%)   6/60 (10%)   9/60 (15%)   7/60 (12%) |
|ADJUSTED (b)           |                                                    |  39.1%        19.7%        26.3%        22.8%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  3/10 (30%)   1/10 (10%)   2/10 (20%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  9/28 (32%)   3/24 (13%)   3/22 (14%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      457 (I)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.385N     P=0.075N     P=0.302N     P=0.350N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.156N     P=0.066N     P=0.214N     P=0.149N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.122N     P=0.050N*    P=0.190N     P=0.085N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.111N                                          |
|FISHER EXACT           |                                                    |               P=0.042N*    P=0.177N     P=0.074N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 14/60 (23%)   6/60 (10%)   9/60 (15%)   7/60 (12%) |
|ADJUSTED (b)           |                                                    |  39.1%        19.7%        26.3%        22.8%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  3/10 (30%)   1/10 (10%)   2/10 (20%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  9/28 (32%)   3/24 (13%)   3/22 (14%)   1/12 (8%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   457 (I)      457 (I)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.385N     P=0.075N     P=0.302N     P=0.350N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.156N     P=0.066N     P=0.214N     P=0.149N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.122N     P=0.050N*    P=0.190N     P=0.085N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.111N                                          |
|FISHER EXACT           |                                                    |               P=0.042N*    P=0.177N     P=0.074N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  24
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  2/60 (3%)    1/60 (2%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.2%         2.2%      |   5.2%         2.5%         0.0%         2.3%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  1/28 (4%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          623          526       |   428          590          ---          591       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.199        (e)        P=0.492      P=0.496    |  P=0.412N     P=0.527N     P=0.274N     P=0.591N   |
|INCIDENTAL TUMOR       |  P=0.265        (e)        P=0.500      P=0.500    |  P=0.321N     P=0.417N     P=0.165N     P=0.521N   |
|LOGISTIC REGRESSION    |  P=0.238        (e)        P=0.480      P=0.501    |  P=0.357N     P=0.484N     P=0.222N     P=0.484N   |
|COCHRAN-ARMITAGE       |  P=0.236                                           |  P=0.367N                                          |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |               P=0.500N     P=0.248N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    2/60 (3%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.6%         0.0%      |   0.0%         0.0%         4.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/10 (0%)    0/6 (0%)     0/4 (0%)     0/1 (0%)   |  0/28 (0%)    0/24 (0%)    0/22 (0%)    0/12 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          355          ---       |   ---          ---          724          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.587        (e)        P=0.232        (e)      |  P=0.614        (e)        P=0.461        (e)      |
|INCIDENTAL TUMOR       |  P=0.624        (e)        P=0.240        (e)      |  P=0.734N       (e)        P=0.607        (e)      |
|LOGISTIC REGRESSION    |  P=0.569        (e)        P=0.203        (e)      |  P=0.637        (e)        P=0.475        (e)      |
|COCHRAN-ARMITAGE       |  P=0.595                                           |  P=0.694                                           |
|FISHER EXACT           |                 (e)        P=0.248        (e)      |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  25
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/60 (50%)  28/60 (47%)  24/60 (40%)  25/60 (42%) | 22/60 (37%)  20/60 (33%)  19/60 (32%)  14/60 (23%) |
|ADJUSTED (b)           |  85.0%        85.1%       100.0%        78.4%      |  54.4%        49.5%        53.5%        43.6%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |  0/10 (0%)    0/10 (0%)    1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |  6/10 (60%)   3/6 (50%)    4/4 (100%)   0/1 (0%)   | 11/28 (39%)   5/24 (21%)   8/22 (36%)   2/12 (17%) |
|FIRST INCIDENCE (DAYS) |   288          553          510          456 (I)   |   524          232          457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.046 *    P=0.524N     P=0.299      P=0.132    |  P=0.463N     P=0.548      P=0.562      P=0.502N   |
|INCIDENTAL TUMOR       |  P=0.215N     P=0.401N     P=0.255N     P=0.225N   |  P=0.015N*    P=0.420N     P=0.498N     P=0.046N*  |
|LOGISTIC REGRESSION    |  P=0.373N     P=0.400N     P=0.325N     P=0.329N   |  P=0.039N*    P=0.468N     P=0.496N     P=0.026N*  |
|COCHRAN-ARMITAGE       |  P=0.184N                                          |  P=0.063N                                          |
|FISHER EXACT           |               P=0.428N     P=0.179N     P=0.232N   |               P=0.424N     P=0.350N     P=0.081N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 57/60 (95%)  55/60 (92%)  58/60 (97%)  56/60 (93%) | 48/60 (80%)  45/60 (75%)  40/60 (67%)  39/60 (65%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  97.9%        95.5%        92.8%        94.7%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  8/10 (80%)   9/10 (90%)   9/10 (90%) |  5/10 (50%)   4/10 (40%)   2/10 (20%)   3/10 (30%) |
|TERMINAL (d)           | 10/10 (100%)  6/6 (100%)   4/4 (100%)   1/1 (100%) | 27/28 (96%)  22/24 (92%)  19/22 (86%)  10/12 (83%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      395          343          456 (I)   |   457 (I)      424          377          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.509      P=0.034 *    P=0.006 ** |  P=0.077      P=0.421      P=0.494N     P=0.074    |
|INCIDENTAL TUMOR       |  P=0.581N     P=0.282N     P=0.500      P=0.549N   |  P=0.052N     P=0.463N     P=0.113N     P=0.104N   |
|LOGISTIC REGRESSION    |  P=0.568N     P=0.279N     P=0.612      P=0.493N   |  P=0.035N*    P=0.471N     P=0.148N     P=0.062N   |
|COCHRAN-ARMITAGE       |  P=0.537N                                          |  P=0.033N*                                         |
|FISHER EXACT           |               P=0.359N     P=0.500      P=0.500N   |               P=0.331N     P=0.074N     P=0.051N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  26
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   VEHICLE      0.125%       0.25%        0.50%     |   VEHICLE      0.25%        0.50%        1.00%     |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 38/60 (63%)  33/60 (55%)  32/60 (53%)  30/60 (50%) | 33/60 (55%)  31/60 (52%)  29/60 (48%)  22/60 (37%) |
|ADJUSTED (b)           |  93.9%        87.1%       100.0%        83.4%      |  70.8%        72.8%        70.4%        61.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    2/10 (20%) |  1/10 (10%)   0/10 (0%)    3/10 (30%)   2/10 (20%) |
|TERMINAL (d)           |  8/10 (80%)   3/6 (50%)    4/4 (100%)   0/1 (0%)   | 15/28 (54%)  13/24 (54%)  11/22 (50%)   3/12 (25%) |
|FIRST INCIDENCE (DAYS) |   288          348          355          262       |   226          232          377          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.067      P=0.377N     P=0.245      P=0.160    |  P=0.528      P=0.469      P=0.531      P=0.545N   |
|INCIDENTAL TUMOR       |  P=0.087N     P=0.222N     P=0.197N     P=0.103N   |  P=0.004N**   P=0.405N     P=0.299N     P=0.011N*  |
|LOGISTIC REGRESSION    |  P=0.174N     P=0.193N     P=0.294N     P=0.136N   |  P=0.029N*    P=0.483N     P=0.354N     P=0.042N*  |
|COCHRAN-ARMITAGE       |  P=0.098N                                          |  P=0.021N*                                         |
|FISHER EXACT           |               P=0.229N     P=0.177N     P=0.099N   |               P=0.427N     P=0.292N     P=0.033N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 59/60 (98%)  57/60 (95%)  59/60 (98%)  59/60 (98%) | 54/60 (90%)  51/60 (85%)  48/60 (80%)  50/60 (83%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      | 100.0%        96.1%        97.9%       100.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  8/10 (80%)   9/10 (90%)   9/10 (90%) |  6/10 (60%)   4/10 (40%)   5/10 (50%)   5/10 (50%) |
|TERMINAL (d)           | 10/10 (100%)  6/6 (100%)   4/4 (100%)   1/1 (100%) | 28/28 (100%) 22/24 (92%)  21/22 (95%)  12/12 (100%)|
|FIRST INCIDENCE (DAYS) |   288          348          343          262       |   226          232          377          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.513      P=0.045 *    P=0.005 ** |  P=0.011 *    P=0.410      P=0.476      P=0.013 *  |
|INCIDENTAL TUMOR       |  P=0.442      P=0.289N     P=0.760      P=0.760    |  P=0.180N     P=0.292N     P=0.154N     P=0.335N   |
|LOGISTIC REGRESSION    |  P=0.512      P=0.134N     P=0.557N     P=0.642N   |  P=0.211N     P=0.375N     P=0.223N     P=0.230N   |
|COCHRAN-ARMITAGE       |  P=0.444                                           |  P=0.190N                                          |
|FISHER EXACT           |               P=0.309N     P=0.752N     P=0.752N   |               P=0.291N     P=0.100N     P=0.211N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05142 TEST: 03                                                 PAGE  27
                             STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- T-BUTYL ALCOHOL
                                                 TERMINAL SACRIFICE AT 105 WEEKS
                                                                           
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 457
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.