https://ntp.niehs.nih.gov/go/4203

TDMS Study 88032-05 Pathology Tables


NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:16:20       
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       
------------------------------------------------------------------------------------------------------------------------------------
                                                            79 WEEK SSAC                                                            
               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
               REMOVAL DATE RANGE:     102094 102194                                                                                
               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: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:16:20       
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
                             Liver                         Basophilic Focus
                                                           Hyperplasia
                                                           Inflammation Chronic
                                                           Mixed Cell Focus
                             Lung                          Inflammation Chronic
                                                           Mineralization
                             Mammary Gland                 Dilatation
                                                           Hyperplasia
                             Testes                        Hyperplasia
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Adrenal Cortex                Vacuolization Cytoplasmic
                             Clitoral Gland                Cyst
                             Intestine Large, Rectum       Parasite Metazoan
                             Kidney                        Nephropathy
                             Liver                         Clear Cell Focus
                                                           Inflammation Chronic
                                                           Vacuolization Cytoplasmic
                             Mammary Gland                 Dilatation
                                                           Hyperplasia
                             Ovary                         DYSGENESIS
              ====================================================================================================
         DATE: 11/24/97                     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                                                                                                                   |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    3/10 (30%)   0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%        30.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    3/10 (30%)   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) |   ---          ---          ---          ---       |   ---          548 (I)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.206N     P=0.111        (e)          (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.206N     P=0.111        (e)          (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.206N     P=0.111        (e)          (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.203N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.105        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/10 (40%)   8/10 (80%)  10/10 (100%) 10/10 (100%)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   9/10 (90%) |
|ADJUSTED (b)           |  40.0%        80.0%       100.0%       100.0%      |   0.0%         0.0%        10.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   8/10 (80%)  10/10 (100%) 10/10 (100%)|  0/10 (0%)    0/10 (0%)    1/10 (10%)   9/10 (90%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   ---          ---          548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.028 *    P=0.091      P=0.009 **   P=0.009 ** |  P<0.001 **     (e)        P=0.500      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.028 *    P=0.091      P=0.009 **   P=0.009 ** |  P<0.001 **     (e)        P=0.500      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.028 *    P=0.091      P=0.009 **   P=0.009 ** |  P<0.001 **     (e)        P=0.500      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.027 *                                         |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.085      P=0.005 **   P=0.005 ** |                 (e)        P=0.500      P<0.001 ** |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   1/10 (10%)   2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|ADJUSTED (b)           |  30.0%        10.0%        20.0%         0.0%      |   0.0%         0.0%        10.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   2/10 (20%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    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) |   548 (I)      548 (I)      548 (I)      ---       |   ---          ---          548 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.140N     P=0.293N     P=0.500N     P=0.111N   |  P=0.785N       (e)        P=0.500        (e)      |
|INCIDENTAL TUMOR       |  P=0.140N     P=0.293N     P=0.500N     P=0.111N   |  P=0.785N       (e)        P=0.500        (e)      |
|LOGISTIC REGRESSION    |  P=0.140N     P=0.293N     P=0.500N     P=0.111N   |  P=0.785N       (e)        P=0.500        (e)      |
|COCHRAN-ARMITAGE       |  P=0.137N                                          |  P=0.788N                                          |
|FISHER EXACT           |               P=0.291N     P=0.500N     P=0.105N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |  0/9 (0%)     0/10 (0%)    0/8 (0%)     3/10 (30%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%        30.0%      |
|INTERIM SACRIFICE 1 (c)|  0/0          0/0          0/0          0/0        |  0/9 (0%)     0/10 (0%)    0/8 (0%)     3/10 (30%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.010 *      (e)          (e)        P=0.129    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.010 *      (e)          (e)        P=0.129    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.010 *      (e)          (e)        P=0.129    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.009 **                                        |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.124    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |  5/9 (56%)    3/10 (30%)   2/8 (25%)    4/10 (40%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  55.6%        30.0%        25.0%        40.0%      |
|INTERIM SACRIFICE 1 (c)|  0/0          0/0          0/0          0/0        |  5/9 (56%)    3/10 (30%)   2/8 (25%)    4/10 (40%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.575N     P=0.260N     P=0.223N     P=0.416N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.575N     P=0.260N     P=0.223N     P=0.416N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.575N     P=0.260N     P=0.223N     P=0.416N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.576N                                          |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.255N     P=0.218N     P=0.414N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|  6/10 (60%)   7/10 (70%)   8/10 (80%)   9/10 (90%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  60.0%        70.0%        80.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|  6/10 (60%)   7/10 (70%)   8/10 (80%)   9/10 (90%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.125      P=0.500      P=0.317      P=0.157    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.125      P=0.500      P=0.317      P=0.157    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.125      P=0.500      P=0.317      P=0.157    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.122                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=1.000N   |               P=0.500      P=0.314      P=0.152    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Rectum                                                                                                          |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   4/10 (40%)   1/10 (10%)   1/10 (10%) |  4/10 (40%)   4/10 (40%)   4/10 (40%)   0/10 (0%)  |
|ADJUSTED (b)           |  20.0%        40.0%        10.0%        10.0%      |  40.0%        40.0%        40.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   1/10 (10%)   1/10 (10%) |  4/10 (40%)   4/10 (40%)   4/10 (40%)   0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.234N     P=0.317      P=0.500N     P=0.500N   |  P=0.025N*    P=0.672      P=0.672      P=0.051N   |
|INCIDENTAL TUMOR       |  P=0.234N     P=0.317      P=0.500N     P=0.500N   |  P=0.025N*    P=0.672      P=0.672      P=0.051N   |
|LOGISTIC REGRESSION    |  P=0.234N     P=0.317      P=0.500N     P=0.500N   |  P=0.025N*    P=0.672      P=0.672      P=0.051N   |
|COCHRAN-ARMITAGE       |  P=0.231N                                          |  P=0.023N*                                         |
|FISHER EXACT           |               P=0.314      P=0.500N     P=0.500N   |               P=0.675N     P=0.675N     P=0.043N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    4/10 (40%) |  8/10 (80%)   9/10 (90%)  10/10 (100%)  9/10 (90%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        40.0%      |  80.0%        90.0%       100.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    4/10 (40%) |  8/10 (80%)   9/10 (90%)  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) |   ---          ---          ---          548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.001 **     (e)          (e)        P=0.051    |  P=0.526      P=0.500      P=0.234      P=0.500    |
|INCIDENTAL TUMOR       |  P=0.001 **     (e)          (e)        P=0.051    |  P=0.526      P=0.500      P=0.234      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.001 **     (e)          (e)        P=0.051    |  P=0.526      P=0.500      P=0.234      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.001 **                                        |  P=0.526                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.043 *  |               P=0.500      P=0.237      P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%) 10/10 (100%)  9/10 (90%)  10/10 (100%)|  8/10 (80%)   4/10 (40%)   9/10 (90%)  10/10 (100%)|
|ADJUSTED (b)           | 100.0%       100.0%        90.0%       100.0%      |  80.0%        40.0%        90.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%)  9/10 (90%)  10/10 (100%)|  8/10 (80%)   4/10 (40%)   9/10 (90%)  10/10 (100%)|
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.765        (e)        P=0.500N       (e)      |  P=0.022 *    P=0.091N     P=0.500      P=0.234    |
|INCIDENTAL TUMOR       |  P=0.765        (e)        P=0.500N       (e)      |  P=0.022 *    P=0.091N     P=0.500      P=0.234    |
|LOGISTIC REGRESSION    |  P=0.765        (e)        P=0.500N       (e)      |  P=0.022 *    P=0.091N     P=0.500      P=0.234    |
|COCHRAN-ARMITAGE       |  P=0.768                                           |  P=0.021 *                                         |
|FISHER EXACT           |               P=1.000N     P=0.500N     P=1.000N   |               P=0.085N     P=0.500      P=0.237    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/10 (40%)   8/10 (80%)   9/10 (90%)   8/10 (80%) |  7/10 (70%)  10/10 (100%) 10/10 (100%)  9/10 (90%) |
|ADJUSTED (b)           |  40.0%        80.0%        90.0%        80.0%      |  70.0%       100.0%       100.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)|  4/10 (40%)   8/10 (80%)   9/10 (90%)   8/10 (80%) |  7/10 (70%)  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) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.270      P=0.091      P=0.034 *    P=0.091    |  P=0.510      P=0.111      P=0.111      P=0.293    |
|INCIDENTAL TUMOR       |  P=0.270      P=0.091      P=0.034 *    P=0.091    |  P=0.510      P=0.111      P=0.111      P=0.293    |
|LOGISTIC REGRESSION    |  P=0.270      P=0.091      P=0.034 *    P=0.091    |  P=0.510      P=0.111      P=0.111      P=0.293    |
|COCHRAN-ARMITAGE       |  P=0.268                                           |  P=0.510                                           |
|FISHER EXACT           |               P=0.085      P=0.029 *    P=0.085    |               P=0.105      P=0.105      P=0.291    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   0/10 (0%)    2/10 (20%)   2/10 (20%) |  0/10 (0%)    1/10 (10%)   0/10 (0%)    3/10 (30%) |
|ADJUSTED (b)           |  20.0%         0.0%        20.0%        20.0%      |   0.0%        10.0%         0.0%        30.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    2/10 (20%)   2/10 (20%) |  0/10 (0%)    1/10 (10%)   0/10 (0%)    3/10 (30%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      ---          548 (I)      548 (I)   |   ---          548 (I)      ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.428      P=0.234N     P=0.707      P=0.707    |  P=0.041 *    P=0.500        (e)        P=0.111    |
|INCIDENTAL TUMOR       |  P=0.428      P=0.234N     P=0.707      P=0.707    |  P=0.041 *    P=0.500        (e)        P=0.111    |
|LOGISTIC REGRESSION    |  P=0.428      P=0.234N     P=0.707      P=0.707    |  P=0.041 *    P=0.500        (e)        P=0.111    |
|COCHRAN-ARMITAGE       |  P=0.427                                           |  P=0.039 *                                         |
|FISHER EXACT           |               P=0.237N     P=0.709N     P=0.709N   |               P=0.500        (e)        P=0.105    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    2/10 (20%)   1/10 (10%)   1/10 (10%) |  2/10 (20%)   1/10 (10%)   2/10 (20%)   1/10 (10%) |
|ADJUSTED (b)           |   0.0%        20.0%        10.0%        10.0%      |  20.0%        10.0%        20.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    2/10 (20%)   1/10 (10%)   1/10 (10%) |  2/10 (20%)   1/10 (10%)   2/10 (20%)   1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.686      P=0.234      P=0.500      P=0.500    |  P=0.493N     P=0.500N     P=0.707      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.686      P=0.234      P=0.500      P=0.500    |  P=0.494N     P=0.500N     P=0.707      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.686      P=0.234      P=0.500      P=0.500    |  P=0.494N     P=0.500N     P=0.707      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.688                                           |  P=0.493N                                          |
|FISHER EXACT           |               P=0.237      P=0.500      P=0.500    |               P=0.500N     P=0.709N     P=0.500N   |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/10 (80%)   5/10 (50%)   1/10 (10%)   0/10 (0%)  |  7/10 (70%)   6/10 (60%)   7/10 (70%)   1/10 (10%) |
|ADJUSTED (b)           |  80.0%        50.0%        10.0%         0.0%      |  70.0%        60.0%        70.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  8/10 (80%)   5/10 (50%)   1/10 (10%)   0/10 (0%)  |  7/10 (70%)   6/10 (60%)   7/10 (70%)   1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      ---       |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002N**   P=0.180N     P=0.004N**   P<0.001N** |  P=0.005N**   P=0.500N     P=0.683      P=0.013N*  |
|INCIDENTAL TUMOR       |  P=0.002N**   P=0.180N     P=0.004N**   P<0.001N** |  P=0.005N**   P=0.500N     P=0.683      P=0.013N*  |
|LOGISTIC REGRESSION    |  P=0.002N**   P=0.180N     P=0.004N**   P<0.001N** |  P=0.005N**   P=0.500N     P=0.683      P=0.013N*  |
|COCHRAN-ARMITAGE       |  P=0.002N**                                        |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.175N     P=0.003N**   P<0.001N** |               P=0.500N     P=0.686N     P=0.010N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    1/10 (10%)   0/10 (0%)    3/10 (30%) |  0/10 (0%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |
|ADJUSTED (b)           |   0.0%        10.0%         0.0%        30.0%      |   0.0%         0.0%        20.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    1/10 (10%)   0/10 (0%)    3/10 (30%) |  0/10 (0%)    0/10 (0%)    2/10 (20%)   0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          548 (I)      ---          548 (I)   |   ---          ---          548 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.037 *    P=0.500        (e)        P=0.111    |  P=0.694N       (e)        P=0.234        (e)      |
|INCIDENTAL TUMOR       |  P=0.037 *    P=0.500        (e)        P=0.111    |  P=0.694N       (e)        P=0.234        (e)      |
|LOGISTIC REGRESSION    |  P=0.037 *    P=0.500        (e)        P=0.111    |  P=0.694N       (e)        P=0.234        (e)      |
|COCHRAN-ARMITAGE       |  P=0.036 *                                         |  P=0.696N                                          |
|FISHER EXACT           |               P=0.500        (e)        P=0.105    |                 (e)        P=0.237        (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%)  6/10 (60%)   6/10 (60%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           | 100.0%        60.0%        60.0%         0.0%      |   0.0%         0.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  6/10 (60%)   6/10 (60%)   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) |   548 (I)      548 (I)      548 (I)      ---       |   ---          ---          ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P=0.051N     P=0.051N     P<0.001N** |  P=0.215        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.051N     P=0.051N     P<0.001N** |  P=0.215        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.051N     P=0.051N     P<0.001N** |  P=0.215        (e)          (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.212                                           |
|FISHER EXACT           |               P=0.043N*    P=0.043N*    P<0.001N** |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   5/10 (50%)   2/10 (20%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    9/10 (90%)   1/10 (10%) |
|ADJUSTED (b)           |  30.0%        50.0%        20.0%        10.0%      |   0.0%         0.0%        90.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   5/10 (50%)   2/10 (20%)   1/10 (10%) |  0/10 (0%)    0/10 (0%)    9/10 (90%)   1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   ---          ---          548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.107N     P=0.328      P=0.500N     P=0.293N   |  P=0.491        (e)        P<0.001 **   P=0.500    |
|INCIDENTAL TUMOR       |  P=0.107N     P=0.328      P=0.500N     P=0.293N   |  P=0.491        (e)        P<0.001 **   P=0.500    |
|LOGISTIC REGRESSION    |  P=0.107N     P=0.328      P=0.500N     P=0.293N   |  P=0.491        (e)        P<0.001 **   P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.104N                                          |  P=0.491                                           |
|FISHER EXACT           |               P=0.325      P=0.500N     P=0.291N   |                 (e)        P<0.001 **   P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    4/10 (40%)   3/9 (33%)    0/10 (0%)  |  1/10 (10%)   4/10 (40%)   4/10 (40%)   3/10 (30%) |
|ADJUSTED (b)           |   0.0%        40.0%        33.3%         0.0%      |  10.0%        40.0%        40.0%        30.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    4/10 (40%)   3/9 (33%)    0/10 (0%)  |  1/10 (10%)   4/10 (40%)   4/10 (40%)   3/10 (30%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          548 (I)      548 (I)      ---       |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.142N     P=0.051      P=0.093        (e)      |  P=0.507      P=0.157      P=0.157      P=0.293    |
|INCIDENTAL TUMOR       |  P=0.142N     P=0.051      P=0.093        (e)      |  P=0.507      P=0.157      P=0.157      P=0.293    |
|LOGISTIC REGRESSION    |  P=0.142N     P=0.051      P=0.093        (e)      |  P=0.507      P=0.157      P=0.157      P=0.293    |
|COCHRAN-ARMITAGE       |  P=0.139N                                          |  P=0.507                                           |
|FISHER EXACT           |               P=0.043 *    P=0.087        (e)      |               P=0.152      P=0.152      P=0.291    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   4/10 (40%)   6/9 (67%)    3/10 (30%) |  2/10 (20%)   1/10 (10%)   5/10 (50%)   3/10 (30%) |
|ADJUSTED (b)           |  10.0%        40.0%        66.7%        30.0%      |  20.0%        10.0%        50.0%        30.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   4/10 (40%)   6/9 (67%)    3/10 (30%) |  2/10 (20%)   1/10 (10%)   5/10 (50%)   3/10 (30%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.617N     P=0.157      P=0.021 *    P=0.293    |  P=0.325      P=0.500N     P=0.180      P=0.500    |
|INCIDENTAL TUMOR       |  P=0.617N     P=0.157      P=0.021 *    P=0.293    |  P=0.325      P=0.500N     P=0.180      P=0.500    |
|LOGISTIC REGRESSION    |  P=0.617N     P=0.157      P=0.021 *    P=0.293    |  P=0.325      P=0.500N     P=0.180      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.618N                                          |  P=0.323                                           |
|FISHER EXACT           |               P=0.152      P=0.017 *    P=0.291    |               P=0.500N     P=0.175      P=0.500    |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   3/10 (30%)   1/9 (11%)    2/10 (20%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  10.0%        30.0%        11.1%        20.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   3/10 (30%)   1/9 (11%)    2/10 (20%) |  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) |   548 (I)      548 (I)      548 (I)      548 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.615      P=0.293      P=0.743      P=0.500    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.615      P=0.293      P=0.743      P=0.500    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.615      P=0.293      P=0.743      P=0.500    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.617                                           |    (e)                                             |
|FISHER EXACT           |               P=0.291      P=0.737      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   3/10 (30%)   1/10 (10%)   7/10 (70%) |  4/10 (40%)   1/10 (10%)   0/10 (0%)    1/10 (10%) |
|ADJUSTED (b)           |  20.0%        30.0%        10.0%        70.0%      |  40.0%        10.0%         0.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   3/10 (30%)   1/10 (10%)   7/10 (70%) |  4/10 (40%)   1/10 (10%)   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) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.009 **   P=0.500      P=0.500N     P=0.040 *  |  P=0.252N     P=0.157N     P=0.051N     P=0.157N   |
|INCIDENTAL TUMOR       |  P=0.009 **   P=0.500      P=0.500N     P=0.040 *  |  P=0.252N     P=0.157N     P=0.051N     P=0.157N   |
|LOGISTIC REGRESSION    |  P=0.009 **   P=0.500      P=0.500N     P=0.040 *  |  P=0.252N     P=0.157N     P=0.051N     P=0.157N   |
|COCHRAN-ARMITAGE       |  P=0.008 **                                        |  P=0.249N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.035 *  |               P=0.152N     P=0.043N*    P=0.152N   |
|=================================================================================================================================|
         DATE: 11/24/97                     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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Galactocele                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  1/10 (10%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  20.0%        10.0%         0.0%         0.0%      |  10.0%        10.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   0/10 (0%)    0/10 (0%)  |  1/10 (10%)   1/10 (10%)   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) |   548 (I)      548 (I)      ---          ---       |   548 (I)      548 (I)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.236N     P=0.500N     P=0.234N     P=0.234N   |  P=0.306N     P=0.766      P=0.500N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.236N     P=0.500N     P=0.234N     P=0.234N   |  P=0.306N     P=0.766      P=0.500N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.236N     P=0.500N     P=0.234N     P=0.234N   |  P=0.306N     P=0.766      P=0.500N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.234N                                          |  P=0.304N                                          |
|FISHER EXACT           |               P=0.500N     P=0.237N     P=0.237N   |               P=0.763N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland: Lobular                                                                                                           |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    6/10 (60%) |  1/10 (10%)   0/10 (0%)    9/10 (90%)   9/10 (90%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        60.0%      |  10.0%         0.0%        90.0%        90.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    6/10 (60%) |  1/10 (10%)   0/10 (0%)    9/10 (90%)   9/10 (90%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          548 (I)   |   548 (I)      ---          548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **     (e)          (e)        P=0.009 ** |  P<0.001 **   P=0.500N     P=0.001 **   P=0.001 ** |
|INCIDENTAL TUMOR       |  P<0.001 **     (e)          (e)        P=0.009 ** |  P<0.001 **   P=0.500N     P=0.001 **   P=0.001 ** |
|LOGISTIC REGRESSION    |  P<0.001 **     (e)          (e)        P=0.009 ** |  P<0.001 **   P=0.500N     P<0.001 **   P<0.001 ** |
|COCHRAN-ARMITAGE       |  P<0.001 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |                 (e)          (e)        P=0.005 ** |               P=0.500N     P<0.001 **   P<0.001 ** |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  12
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/3 (67%)    1/1 (100%)   3/3 (100%)   0/0 (0%)   |  4/4 (100%)   3/3 (100%)   2/2 (100%)   1/1 (100%) |
|ADJUSTED (b)           |  66.7%       100.0%       100.0%         0.0%      | 100.0%       100.0%       100.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  2/3 (67%)    1/1 (100%)   3/3 (100%)   0/0        |  4/4 (100%)   3/3 (100%)   2/2 (100%)   1/1 (100%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      ---       |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.999      P=0.718      P=0.500        (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.999      P=0.718      P=0.500        (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.999      P=0.718      P=0.500        (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=1.000                                           |    (e)                                             |
|FISHER EXACT           |               P=0.750      P=0.500      P=1.000N   |               P=1.000N     P=1.000N     P=1.000N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/10 (10%)   2/10 (20%)   1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    1/10 (10%)   0/10 (0%)  |
|ADJUSTED (b)           |  10.0%        20.0%        10.0%         0.0%      |   0.0%         0.0%        10.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   1/10 (10%)   0/10 (0%)  |  0/10 (0%)    0/10 (0%)    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) |   548 (I)      548 (I)      548 (I)      ---       |   ---          ---          548 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.230N     P=0.500      P=0.766      P=0.500N   |  P=0.785N       (e)        P=0.500        (e)      |
|INCIDENTAL TUMOR       |  P=0.230N     P=0.500      P=0.766      P=0.500N   |  P=0.785N       (e)        P=0.500        (e)      |
|LOGISTIC REGRESSION    |  P=0.230N     P=0.500      P=0.766      P=0.500N   |  P=0.785N       (e)        P=0.500        (e)      |
|COCHRAN-ARMITAGE       |  P=0.227N                                          |  P=0.788N                                          |
|FISHER EXACT           |               P=0.500      P=0.763N     P=0.500N   |                 (e)        P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  13
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     DYSGENESIS                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/10 (0%)    0/10 (0%)    8/10 (80%)  10/10 (100%)|
|ADJUSTED (b)           |                                                    |   0.0%         0.0%        80.0%       100.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    8/10 (80%)  10/10 (100%)|
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          548 (I)      548 (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 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary: Periovarian Tissue                                                                                                        |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/10 (30%)   1/10 (10%)   1/10 (10%)   1/10 (10%) |
|ADJUSTED (b)           |                                                    |  30.0%        10.0%        10.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  3/10 (30%)   1/10 (10%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.366N     P=0.293N     P=0.293N     P=0.293N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.366N     P=0.293N     P=0.293N     P=0.293N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.366N     P=0.293N     P=0.293N     P=0.293N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.365N                                          |
|FISHER EXACT           |                                                    |               P=0.291N     P=0.291N     P=0.291N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  14
                              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)            |  1/10 (10%)   2/10 (20%)   2/10 (20%)   0/10 (0%)  |  1/10 (10%)   0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|ADJUSTED (b)           |  10.0%        20.0%        20.0%         0.0%      |  10.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   2/10 (20%)   0/10 (0%)  |  1/10 (10%)   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) |   548 (I)      548 (I)      548 (I)      ---       |   548 (I)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.214N     P=0.500      P=0.500      P=0.500N   |  P=0.517N     P=0.500N     P=0.500N     P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.214N     P=0.500      P=0.500      P=0.500N   |  P=0.517N     P=0.500N     P=0.500N     P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.214N     P=0.500      P=0.500      P=0.500N   |  P=0.517N     P=0.500N     P=0.500N     P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.212N                                          |  P=0.518N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/9 (0%)   |  2/10 (20%)   1/9 (11%)    2/10 (20%)   1/10 (10%) |
|ADJUSTED (b)           |  20.0%         0.0%         0.0%         0.0%      |  20.0%        11.1%        20.0%        10.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    0/10 (0%)    0/9 (0%)   |  2/10 (20%)   1/9 (11%)    2/10 (20%)   1/10 (10%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      ---          ---          ---       |   548 (I)      548 (I)      548 (I)      548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.377N     P=0.234N     P=0.234N     P=0.257N   |  P=0.473N     P=0.539N     P=0.707      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.377N     P=0.234N     P=0.234N     P=0.257N   |  P=0.473N     P=0.539N     P=0.707      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.377N     P=0.234N     P=0.234N     P=0.257N   |  P=0.473N     P=0.539N     P=0.707      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.375N                                          |  P=0.473N                                          |
|FISHER EXACT           |               P=0.237N     P=0.237N     P=0.263N   |               P=0.542N     P=0.709N     P=0.500N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  15
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   3/10 (30%)   2/10 (20%)   1/9 (11%)  |  1/10 (10%)   1/9 (11%)    0/10 (0%)    2/10 (20%) |
|ADJUSTED (b)           |  20.0%        30.0%        20.0%        11.1%      |  10.0%        11.1%         0.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   3/10 (30%)   2/10 (20%)   1/9 (11%)  |  1/10 (10%)   1/9 (11%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |   548 (I)      548 (I)      ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.334N     P=0.500      P=0.707      P=0.539N   |  P=0.341      P=0.743      P=0.500N     P=0.500    |
|INCIDENTAL TUMOR       |  P=0.334N     P=0.500      P=0.707      P=0.539N   |  P=0.341      P=0.743      P=0.500N     P=0.500    |
|LOGISTIC REGRESSION    |  P=0.334N     P=0.500      P=0.707      P=0.539N   |  P=0.341      P=0.743      P=0.500N     P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.332N                                          |  P=0.339                                           |
|FISHER EXACT           |               P=0.500      P=0.709N     P=0.542N   |               P=0.737      P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/10 (100%)  8/10 (80%)   9/10 (90%)   8/10 (80%) |  0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)   |
|ADJUSTED (b)           | 100.0%        80.0%        90.0%        80.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%)  8/10 (80%)   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) |   548 (I)      548 (I)      548 (I)      548 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.358N     P=0.234N     P=0.500N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.358N     P=0.234N     P=0.500N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.358N     P=0.234N     P=0.500N     P=0.234N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.356N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.237N     P=0.500N     P=0.237N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  16
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |                                                    |
|ADJUSTED (b)           |  20.0%        20.0%         0.0%         0.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   2/10 (20%)   0/10 (0%)    0/10 (0%)  |                                                    |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |                                                    |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.160N     P=0.707      P=0.234N     P=0.234N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.160N     P=0.707      P=0.234N     P=0.234N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.160N     P=0.707      P=0.234N     P=0.234N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.157N                                          |                                                    |
|FISHER EXACT           |               P=0.709N     P=0.237N     P=0.237N   |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   1/10 (10%)   2/10 (20%)   3/10 (30%) |                                                    |
|ADJUSTED (b)           |  20.0%        10.0%        20.0%        30.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   1/10 (10%)   2/10 (20%)   3/10 (30%) |                                                    |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |                                                    |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.290      P=0.500N     P=0.707      P=0.500    |                                                    |
|INCIDENTAL TUMOR       |  P=0.290      P=0.500N     P=0.707      P=0.500    |                                                    |
|LOGISTIC REGRESSION    |  P=0.290      P=0.500N     P=0.707      P=0.500    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.287                                           |                                                    |
|FISHER EXACT           |               P=0.500N     P=0.709N     P=0.500    |                                                    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  17
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   1/10 (10%)   7/10 (70%)   4/10 (40%) |                                                    |
|ADJUSTED (b)           |  30.0%        10.0%        70.0%        40.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   1/10 (10%)   7/10 (70%)   4/10 (40%) |                                                    |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |                                                    |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      548 (I)      548 (I)   |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.363      P=0.293N     P=0.095      P=0.500    |                                                    |
|INCIDENTAL TUMOR       |  P=0.363      P=0.293N     P=0.095      P=0.500    |                                                    |
|LOGISTIC REGRESSION    |  P=0.363      P=0.293N     P=0.090      P=0.500    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.361                                           |                                                    |
|FISHER EXACT           |               P=0.291N     P=0.089      P=0.500    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Interstitial Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/10 (30%)   4/10 (40%)   0/10 (0%)    0/10 (0%)  |                                                    |
|ADJUSTED (b)           |  30.0%        40.0%         0.0%         0.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  3/10 (30%)   4/10 (40%)   0/10 (0%)    0/10 (0%)  |                                                    |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |                                                    |
|FIRST INCIDENCE (DAYS) |   548 (I)      548 (I)      ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.048N*    P=0.500      P=0.111N     P=0.111N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.048N*    P=0.500      P=0.111N     P=0.111N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.048N*    P=0.500      P=0.111N     P=0.111N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.046N*                                         |                                                    |
|FISHER EXACT           |               P=0.500      P=0.105N     P=0.105N   |                                                    |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  18
                              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     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/10 (20%)   0/10 (0%)    0/9 (0%)     1/10 (10%) |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|ADJUSTED (b)           |  20.0%         0.0%         0.0%        10.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   0/10 (0%)    0/9 (0%)     1/10 (10%) |  0/10 (0%)    0/9 (0%)     0/10 (0%)    0/9 (0%)   |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   548 (I)      ---          ---          548 (I)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.678      P=0.234N     P=0.257N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.678      P=0.234N     P=0.257N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.678      P=0.234N     P=0.257N     P=0.500N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.681                                           |    (e)                                             |
|FISHER EXACT           |               P=0.237N     P=0.263N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  1/10 (10%)   0/10 (0%)    2/10 (20%)   0/10 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%        10.0%      |  10.0%         0.0%        20.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    1/10 (10%) |  1/10 (10%)   0/10 (0%)    2/10 (20%)   0/10 (0%)  |
|TERMINAL (d)           |  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          548 (I)   |   548 (I)      ---          548 (I)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.235        (e)          (e)        P=0.500    |  P=0.472N     P=0.500N     P=0.500      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.235        (e)          (e)        P=0.500    |  P=0.472N     P=0.500N     P=0.500      P=0.500N   |
|LOGISTIC REGRESSION    |  P=0.235        (e)          (e)        P=0.500    |  P=0.472N     P=0.500N     P=0.500      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.232                                           |  P=0.472N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.500N     P=0.500      P=0.500N   |
|=================================================================================================================================|
         DATE: 11/24/97                     EXPERIMENT: 88032 TEST: 05                                                 PAGE  19
                              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)            |                                                    |  3/10 (30%)   0/10 (0%)    0/10 (0%)    2/10 (20%) |
|ADJUSTED (b)           |                                                    |  30.0%         0.0%         0.0%        20.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  3/10 (30%)   0/10 (0%)    0/10 (0%)    2/10 (20%) |
|TERMINAL (d)           |                                                    |  0/0          0/0          0/0          0/0        |
|FIRST INCIDENCE (DAYS) |                                                    |   548 (I)      ---          ---          548 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.506      P=0.111N     P=0.111N     P=0.500N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.506      P=0.111N     P=0.111N     P=0.500N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.506      P=0.111N     P=0.111N     P=0.500N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.506                                           |
|FISHER EXACT           |                                                    |               P=0.105N     P=0.105N     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):   548
          Female interim sacrifices(days): 548
 (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).