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TDMS Study 88032-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/25/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 07:20:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            27 WEEK SSAC                                                            
                                                                                                                                    

               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     102193 102293                                                                                
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    3 MG/KG                                                                       
                                       INCLUDE 004    3 MG/KG                                                                       
                                       INCLUDE 005    30 MG/KG                                                                      
                                       INCLUDE 006    30 MG/KG                                                                      
                                       INCLUDE 007    150     MG/KG                                                                 
                                       INCLUDE 008    100     MG/KG                                                                 
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/25/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 07:20:57       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       




                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                          IN THE ANALYSIS OF THE STUDY OF OXYMETHOLONE

              ====================================================================================================

                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Adrenal Cortex                Vacuolization Cytoplasmic
                             Kidney                        Mineralization
                             Lung                          Inflammation Chronic
                                                           Mineralization
                             Mammary Gland                 Dilatation

              ====================================================================================================

                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Clitoral Gland                Inflammation Chronic
                             Heart                         Degeneration Chronic
                             Kidney                        Nephropathy
                             Lung                          Inflammation Chronic
                                                           Mineralization
                             Mammary Gland                 Hyperplasia
                             Ovary                         DYSGENESIS

              ====================================================================================================
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   1
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Accessory Adrenal Cortical Nodule                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%) |  3/10 (30%)   2/10 (20%)   1/10 (10%)   0/10 (0%)  |
|ADJUSTED (b)           |   0.0%        10.0%        10.0%        10.0%      |  30.0%        20.0%        10.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   1/10 (10%)   1/10 (10%) |  3/10 (30%)   2/10 (20%)   1/10 (10%)   0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          184 (I)      184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.555      P=0.500      P=0.500      P=0.500    |  P=0.081N     P=0.500N     P=0.293N     P=0.111N   |
|INCIDENTAL TUMOR       |  P=0.555      P=0.500      P=0.500      P=0.500    |  P=0.081N     P=0.500N     P=0.293N     P=0.111N   |
|LOGISTIC REGRESSION    |  P=0.555      P=0.500      P=0.500      P=0.500    |  P=0.081N     P=0.500N     P=0.293N     P=0.111N   |
|COCHRAN-ARMITAGE       |  P=0.555                                           |  P=0.079N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.500N     P=0.291N     P=0.105N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%)  8/10 (80%)   0/10 (0%)    8/10 (80%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           | 100.0%        80.0%         0.0%        80.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  8/10 (80%)   0/10 (0%)    8/10 (80%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      ---          184 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.554      P=0.234N     P<0.001N**   P=0.234N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.554      P=0.234N     P<0.001N**   P=0.234N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.554      P=0.234N     P<0.001N**   P=0.234N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.555                                           |    (e)                                             |
|FISHER EXACT           |               P=0.237N     P<0.001N**   P=0.237N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   2
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |  6/10 (60%)   7/10 (70%)  10/10 (100%)  8/10 (80%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  60.0%        70.0%       100.0%        80.0%      |
|INTERIM SACRIFICE 1 (c)|  0/0          0/0          0/0          0/0        |  6/10 (60%)   7/10 (70%)  10/10 (100%)  8/10 (80%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.304      P=0.500      P=0.051      P=0.317    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.304      P=0.500      P=0.051      P=0.317    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.304      P=0.500      P=0.051      P=0.317    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.302                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.500      P=0.043 *    P=0.314    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%) 10/10 (100%)  9/10 (90%)  10/10 (100%)|  5/10 (50%)   5/10 (50%)   7/10 (70%)  10/10 (100%)|
|ADJUSTED (b)           | 100.0%       100.0%        90.0%       100.0%      |  50.0%        50.0%        70.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%)  9/10 (90%)  10/10 (100%)|  5/10 (50%)   5/10 (50%)   7/10 (70%)  10/10 (100%)|
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.765        (e)        P=0.500N       (e)      |  P=0.008 **   P=0.669      P=0.328      P=0.022 *  |
|INCIDENTAL TUMOR       |  P=0.765        (e)        P=0.500N       (e)      |  P=0.008 **   P=0.669      P=0.328      P=0.022 *  |
|LOGISTIC REGRESSION    |  P=0.765        (e)        P=0.500N       (e)      |  P=0.008 **   P=0.669      P=0.328      P=0.022 *  |
|COCHRAN-ARMITAGE       |  P=0.768                                           |  P=0.007 **                                        |
|FISHER EXACT           |               P=1.000N     P=0.500N     P=1.000N   |               P=0.672N     P=0.325      P=0.016 *  |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   3
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   0/10 (0%)    1/10 (10%)   9/10 (90%) | 10/10 (100%) 10/10 (100%) 10/10 (100%)  9/10 (90%) |
|ADJUSTED (b)           |  20.0%         0.0%        10.0%        90.0%      | 100.0%       100.0%       100.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    1/10 (10%)   9/10 (90%) | 10/10 (100%) 10/10 (100%) 10/10 (100%)  9/10 (90%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      ---          184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.234N     P=0.500N     P=0.004 ** |  P=0.215N       (e)          (e)        P=0.500N   |
|INCIDENTAL TUMOR       |  P<0.001 **   P=0.234N     P=0.500N     P=0.004 ** |  P=0.215N       (e)          (e)        P=0.500N   |
|LOGISTIC REGRESSION    |  P<0.001 **   P=0.234N     P=0.500N     P=0.004 ** |  P=0.215N       (e)          (e)        P=0.500N   |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.212N                                          |
|FISHER EXACT           |               P=0.237N     P=0.500N     P=0.003 ** |               P=1.000N     P=1.000N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/10 (80%)   7/10 (70%)   9/10 (90%)  10/10 (100%)|  0/10 (0%)    1/10 (10%)   2/10 (20%)   7/10 (70%) |
|ADJUSTED (b)           |  80.0%        70.0%        90.0%       100.0%      |   0.0%        10.0%        20.0%        70.0%      |
|INTERIM SACRIFICE 1 (c)|  8/10 (80%)   7/10 (70%)   9/10 (90%)  10/10 (100%)|  0/10 (0%)    1/10 (10%)   2/10 (20%)   7/10 (70%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   ---          184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.105      P=0.500N     P=0.500      P=0.234    |  P<0.001 **   P=0.500      P=0.234      P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.105      P=0.500N     P=0.500      P=0.234    |  P<0.001 **   P=0.500      P=0.234      P=0.003 ** |
|LOGISTIC REGRESSION    |  P=0.105      P=0.500N     P=0.500      P=0.234    |  P<0.001 **   P=0.500      P=0.234      P=0.003 ** |
|COCHRAN-ARMITAGE       |  P=0.102                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.237    |               P=0.500      P=0.237      P=0.002 ** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   4
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   1/10 (10%)   1/10 (10%)   1/10 (10%) |  1/10 (10%)   5/10 (50%)   1/10 (10%)   2/10 (20%) |
|ADJUSTED (b)           |  10.0%        10.0%        10.0%        10.0%      |  10.0%        50.0%        10.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   1/10 (10%)   1/10 (10%)   1/10 (10%) |  1/10 (10%)   5/10 (50%)   1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.695      P=0.766      P=0.766      P=0.766    |  P=0.429N     P=0.077      P=0.766      P=0.500    |
|INCIDENTAL TUMOR       |  P=0.695      P=0.766      P=0.766      P=0.766    |  P=0.429N     P=0.077      P=0.766      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.695      P=0.766      P=0.766      P=0.766    |  P=0.429N     P=0.077      P=0.766      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.697                                           |  P=0.428N                                          |
|FISHER EXACT           |               P=0.763N     P=0.763N     P=0.763N   |               P=0.070      P=0.763N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   1/10 (10%)   3/10 (30%)   1/10 (10%) |  2/10 (20%)   5/10 (50%)   4/10 (40%)   2/10 (20%) |
|ADJUSTED (b)           |  30.0%        10.0%        30.0%        10.0%      |  20.0%        50.0%        40.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   3/10 (30%)   1/10 (10%) |  2/10 (20%)   5/10 (50%)   4/10 (40%)   2/10 (20%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.344N     P=0.293N     P=0.683      P=0.293N   |  P=0.303N     P=0.180      P=0.317      P=0.707    |
|INCIDENTAL TUMOR       |  P=0.344N     P=0.293N     P=0.683      P=0.293N   |  P=0.303N     P=0.180      P=0.317      P=0.707    |
|LOGISTIC REGRESSION    |  P=0.344N     P=0.293N     P=0.683      P=0.293N   |  P=0.303N     P=0.180      P=0.317      P=0.707    |
|COCHRAN-ARMITAGE       |  P=0.342N                                          |  P=0.301N                                          |
|FISHER EXACT           |               P=0.291N     P=0.686N     P=0.291N   |               P=0.175      P=0.314      P=0.709N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   5
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  30.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.228N     P=0.111N     P=0.111N     P=0.111N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.228N     P=0.111N     P=0.111N     P=0.111N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.228N     P=0.111N     P=0.111N     P=0.111N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.225N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.105N     P=0.105N     P=0.105N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   3/10 (30%)   8/10 (80%)   3/10 (30%) |  2/10 (20%)   4/10 (40%)   7/10 (70%)   2/10 (20%) |
|ADJUSTED (b)           |  20.0%        30.0%        80.0%        30.0%      |  20.0%        40.0%        70.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   3/10 (30%)   8/10 (80%)   3/10 (30%) |  2/10 (20%)   4/10 (40%)   7/10 (70%)   2/10 (20%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.556N     P=0.500      P=0.015 *    P=0.500    |  P=0.369N     P=0.317      P=0.040 *    P=0.707    |
|INCIDENTAL TUMOR       |  P=0.556N     P=0.500      P=0.015 *    P=0.500    |  P=0.369N     P=0.317      P=0.040 *    P=0.707    |
|LOGISTIC REGRESSION    |  P=0.556N     P=0.500      P=0.015 *    P=0.500    |  P=0.369N     P=0.317      P=0.040 *    P=0.707    |
|COCHRAN-ARMITAGE       |  P=0.557N                                          |  P=0.367N                                          |
|FISHER EXACT           |               P=0.500      P=0.012 *    P=0.500    |               P=0.314      P=0.035 *    P=0.709N   |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   6
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  10.0%        20.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.245N     P=0.500      P=0.500N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.245N     P=0.500      P=0.500N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.245N     P=0.500      P=0.500N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    4/10 (40%)   4/10 (40%)   1/10 (10%) |  0/10 (0%)    2/10 (20%)   4/10 (40%)   1/10 (10%) |
|ADJUSTED (b)           |   0.0%        40.0%        40.0%        10.0%      |   0.0%        20.0%        40.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    4/10 (40%)   4/10 (40%)   1/10 (10%) |  0/10 (0%)    2/10 (20%)   4/10 (40%)   1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          184 (I)      184 (I)      184 (I)   |   ---          184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.335N     P=0.051      P=0.051      P=0.500    |  P=0.613N     P=0.234      P=0.051      P=0.500    |
|INCIDENTAL TUMOR       |  P=0.335N     P=0.051      P=0.051      P=0.500    |  P=0.613N     P=0.234      P=0.051      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.335N     P=0.051      P=0.051      P=0.500    |  P=0.613N     P=0.234      P=0.051      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.333N                                          |  P=0.615N                                          |
|FISHER EXACT           |               P=0.043 *    P=0.043 *    P=0.500    |               P=0.237      P=0.043 *    P=0.500    |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   7
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    9/10 (90%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        90.0%      |   0.0%         0.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    9/10 (90%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          184 (I)   |   ---          ---          ---          184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P<0.001 ** |  P=0.215        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P<0.001 ** |  P=0.215        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P<0.001 ** |  P=0.215        (e)          (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P=0.212                                           |
|FISHER EXACT           |                 (e)          (e)        P<0.001 ** |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland: Lobular                                                                                                           |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)   10/10 (100%) 10/10 (100%)|
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)   10/10 (100%) 10/10 (100%)|
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |    (e)                                             |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   8
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   0/10 (0%)    2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  10.0%         0.0%        20.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      ---          184 (I)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.434N     P=0.500N     P=0.500      P=0.500N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.434N     P=0.500N     P=0.500      P=0.500N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.434N     P=0.500N     P=0.500      P=0.500N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.433N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     DYSGENESIS                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/10 (0%)    0/10 (0%)   10/10 (100%) 10/10 (100%)|
|ADJUSTED (b)           |                                                    |   0.0%         0.0%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)   10/10 (100%) 10/10 (100%)|
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|INCIDENTAL TUMOR       |                                                    |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|LOGISTIC REGRESSION    |                                                    |  P<0.001 **     (e)        P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |                                                    |  P<0.001 **                                        |
|FISHER EXACT           |                                                    |                 (e)        P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE   9
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           |   0.0%        20.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    2/10 (20%)   0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          184 (I)      ---          ---       |   ---          ---          ---          184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.383N     P=0.234        (e)          (e)      |  P=0.215        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.383N     P=0.234        (e)          (e)      |  P=0.215        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.383N     P=0.234        (e)          (e)      |  P=0.215        (e)          (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.381N                                          |  P=0.212                                           |
|FISHER EXACT           |               P=0.237        (e)          (e)      |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/10 (70%)  10/10 (100%)  9/10 (90%)   8/10 (80%) |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           |  70.0%       100.0%        90.0%        80.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  7/10 (70%)  10/10 (100%)  9/10 (90%)   8/10 (80%) |  0/0          0/0          0/0          0/0        |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      184 (I)      184 (I)      184 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.513N     P=0.111      P=0.293      P=0.500    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.513N     P=0.111      P=0.293      P=0.500    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.513N     P=0.111      P=0.293      P=0.500    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.513N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.105      P=0.291      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  10
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland                                                                                                                    |
|     Ultimobranchial Cyst                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%) |
|ADJUSTED (b)           |  10.0%         0.0%         0.0%         0.0%      |   0.0%        10.0%        10.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      ---          ---          ---       |   ---          184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.592N     P=0.500N     P=0.500N     P=0.500N   |  P=0.200      P=0.500      P=0.500      P=0.234    |
|INCIDENTAL TUMOR       |  P=0.592N     P=0.500N     P=0.500N     P=0.500N   |  P=0.200      P=0.500      P=0.500      P=0.234    |
|LOGISTIC REGRESSION    |  P=0.592N     P=0.500N     P=0.500N     P=0.500N   |  P=0.200      P=0.500      P=0.500      P=0.234    |
|COCHRAN-ARMITAGE       |  P=0.593N                                          |  P=0.197                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.500      P=0.500      P=0.237    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicle                                                                                                          |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  20.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   184 (I)      ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.356N     P=0.234N     P=0.234N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.356N     P=0.234N     P=0.234N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.356N     P=0.234N     P=0.234N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.355N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.237N     P=0.237N     P=0.237N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/25/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  11
                              STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN RATS(FISCHER344) -- OXYMETHOLONE

                                                 TERMINAL SACRIFICE AT . WEEKS

|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      3 MG/KG      30 MG/KG     150       |   0 MG/KG      3 MG/KG      30 MG/KG     100       |
|                       |                                          MG/KG     |                                          MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hydrometra                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/10 (20%)   3/10 (30%)   4/10 (40%)   1/10 (10%) |
|ADJUSTED (b)           |                                                    |  20.0%        30.0%        40.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  2/10 (20%)   3/10 (30%)   4/10 (40%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   184 (I)      184 (I)      184 (I)      184 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.270N     P=0.500      P=0.317      P=0.500N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.270N     P=0.500      P=0.317      P=0.500N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.270N     P=0.500      P=0.317      P=0.500N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.267N                                          |
|FISHER EXACT           |                                                    |               P=0.500      P=0.314      P=0.500N   |
|=================================================================================================================================|

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   184
          Female interim sacrifices(days): 184
 (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).