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TDMS Study 05098-01 Pathology Tables


NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                            P-NITROPHENOL                                     DATE: 09/13/94       
EXPERIMENT: 05098 TEST: 01                                                                                     TIME: 13:11:31       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES45040            ROUTE: DERMAL,SOLUTION                                                             NTP C#: 55992B       
PATHOLOGIST: R. CARDY                        S. EUSTIS                                                         CAS: 100-02-7        
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Hazelton, MD                                            P-NITROPHENOL                                     DATE: 09/13/94      
EXPERIMENT: 05098 TEST: 01                                                                                     TIME: 13:11:31      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES45040            ROUTE: DERMAL,SOLUTION                                                             NTP C#: 55992B      
PATHOLOGIST: R. CARDY                        S. EUSTIS                                                         CAS: 100-02-7       
                                                    35(  )
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                    ----------------
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                            P-NITROPHENOL                                     DATE: 09/13/94       
EXPERIMENT: 05098 TEST: 01                                                                                     TIME: 13:11:31       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES45040            ROUTE: DERMAL,SOLUTION                                                             NTP C#: 55992B       
PATHOLOGIST: R. CARDY                        S. EUSTIS                                                         CAS: 100-02-7        
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF P-NITROPHENOL
              ====================================================================================================
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Stomach, Forestomach          Squamous Cell Papilloma
                             Uterus                        Schwannoma Malignant
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant and Benign Tumors
              ====================================================================================================
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   1
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    7/58 (12%)   6/59 (10%)   6/59 (10%) |  0/60 (0%)    0/59 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |  13.2%        37.3%        20.6%        20.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  3/29 (10%)   6/17 (35%)   4/25 (16%)   3/23 (13%) |  0/35 (0%)    0/26 (0%)    0/33 (0%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   536          503          435          442       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.326      P=0.060      P=0.305      P=0.250    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.338      P=0.080      P=0.351      P=0.334    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.299      P=0.115      P=0.332      P=0.272    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.392                                           |    (e)                                             |
|FISHER EXACT           |               P=0.245      P=0.361      P=0.361    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         5.9%         0.0%         0.0%      |   0.0%         3.8%         0.0%         5.6%      |
|TERMINAL (d)           |  0/29 (0%)    1/17 (6%)    0/26 (0%)    0/24 (0%)  |  0/35 (0%)    1/26 (4%)    0/33 (0%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          552 (T)      ---          ---       |   ---          552 (T)      ---          468       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.573N     P=0.393        (e)          (e)      |  P=0.126      P=0.441        (e)        P=0.215    |
|INCIDENTAL TUMOR       |  P=0.573N     P=0.393        (e)          (e)      |  P=0.136      P=0.441        (e)        P=0.245    |
|LOGISTIC REGRESSION    |  P=0.573N     P=0.393        (e)          (e)      |  P=0.141      P=0.441        (e)        P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.567N                                          |  P=0.140                                           |
|FISHER EXACT           |               P=0.500        (e)          (e)      |               P=0.500        (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   2
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/59 (0%)    2/60 (3%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         7.7%         4.2%      |   0.0%         0.0%         0.0%         3.7%      |
|TERMINAL (d)           |  0/29 (0%)    0/17 (0%)    2/26 (8%)    1/24 (4%)  |  0/35 (0%)    0/26 (0%)    0/33 (0%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          552 (T)      552 (T)   |   ---          ---          ---          552 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.239        (e)        P=0.214      P=0.462    |  P=0.179        (e)          (e)        P=0.448    |
|INCIDENTAL TUMOR       |  P=0.239        (e)        P=0.214      P=0.462    |  P=0.179        (e)          (e)        P=0.448    |
|LOGISTIC REGRESSION    |  P=0.239        (e)        P=0.214      P=0.462    |  P=0.178        (e)          (e)        P=0.448    |
|COCHRAN-ARMITAGE       |  P=0.247                                           |  P=0.199                                           |
|FISHER EXACT           |                 (e)        P=0.248      P=0.500    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    3/59 (5%)    5/60 (8%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.4%        14.7%        17.9%         4.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    4/26 (15%)   1/24 (4%)  |  0/35 (0%)    0/26 (0%)    0/33 (0%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   552 (T)      545          519          552 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.583N     P=0.167      P=0.082      P=0.720    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.575      P=0.313      P=0.085      P=0.720    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.569      P=0.192      P=0.092      P=0.720    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.541N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.303      P=0.103      P=0.752N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   3
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)   11/58 (19%)  12/60 (20%)   6/60 (10%) |  7/60 (12%)   8/60 (13%)   8/60 (13%)   6/60 (10%) |
|ADJUSTED (b)           |  11.2%        35.8%        34.0%        20.2%      |  16.7%        22.3%        19.9%        18.0%      |
|TERMINAL (d)           |  2/29 (7%)    3/17 (18%)   6/26 (23%)   4/24 (17%) |  4/35 (11%)   2/26 (8%)    5/33 (15%)   3/27 (11%) |
|FIRST INCIDENCE (DAYS) |   409          438          454          442       |   438          449          446          454       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.409      P=0.014 *    P=0.024 *    P=0.282    |  P=0.476N     P=0.360      P=0.479      P=0.609N   |
|INCIDENTAL TUMOR       |  P=0.506      P=0.045 *    P=0.025 *    P=0.350    |  P=0.388N     P=0.594N     P=0.498      P=0.491N   |
|LOGISTIC REGRESSION    |  P=0.467      P=0.034 *    P=0.028 *    P=0.341    |  P=0.403N     P=0.491      P=0.500      P=0.501N   |
|COCHRAN-ARMITAGE       |  P=0.498                                           |  P=0.407N                                          |
|FISHER EXACT           |               P=0.041 *    P=0.029 *    P=0.372    |               P=0.500      P=0.500      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    9/58 (16%)   6/60 (10%)   7/60 (12%) |  4/60 (7%)    1/60 (2%)    5/60 (8%)    5/60 (8%)  |
|ADJUSTED (b)           |  16.6%        35.6%        14.6%        27.6%      |  11.4%         2.4%        11.9%        18.5%      |
|TERMINAL (d)           |  4/29 (14%)   4/17 (24%)   1/26 (4%)    6/24 (25%) |  4/35 (11%)   0/26 (0%)    2/33 (6%)    5/27 (19%) |
|FIRST INCIDENCE (DAYS) |   536          486          293          514       |   552 (T)      497          427          552 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.387      P=0.047 *    P=0.469      P=0.247    |  P=0.191      P=0.260N     P=0.486      P=0.338    |
|INCIDENTAL TUMOR       |  P=0.477      P=0.091      P=0.495      P=0.292    |  P=0.220      P=0.238N     P=0.493      P=0.338    |
|LOGISTIC REGRESSION    |  P=0.417      P=0.099      P=0.499      P=0.231    |  P=0.250      P=0.211N     P=0.516      P=0.338    |
|COCHRAN-ARMITAGE       |  P=0.468                                           |  P=0.249                                           |
|FISHER EXACT           |               P=0.179      P=0.500      P=0.381    |               P=0.182N     P=0.500      P=0.500    |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   4
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)  20/58 (34%)  17/60 (28%)  11/60 (18%) | 11/60 (18%)   9/60 (15%)  12/60 (20%)  11/60 (18%) |
|ADJUSTED (b)           |  26.8%        61.4%        42.4%        38.3%      |  27.4%        24.1%        28.8%        35.1%      |
|TERMINAL (d)           |  6/29 (21%)   7/17 (41%)   7/26 (27%)   8/24 (33%) |  8/35 (23%)   2/26 (8%)    7/33 (21%)   8/27 (30%) |
|FIRST INCIDENCE (DAYS) |   409          438          293          442       |   438          449          427          454       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.494      P=0.001 **   P=0.051      P=0.248    |  P=0.366      P=0.589N     P=0.473      P=0.395    |
|INCIDENTAL TUMOR       |  P=0.442N     P=0.006 **   P=0.053      P=0.333    |  P=0.453      P=0.333N     P=0.490      P=0.492    |
|LOGISTIC REGRESSION    |  P=0.505N     P=0.005 **   P=0.058      P=0.287    |  P=0.475      P=0.426N     P=0.517      P=0.576    |
|COCHRAN-ARMITAGE       |  P=0.455N                                          |  P=0.466                                           |
|FISHER EXACT           |               P=0.012 *    P=0.060      P=0.404    |               P=0.404N     P=0.500      P=0.593N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   3.1%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         5.7%      |
|TERMINAL (d)           |  0/29 (0%)    0/17 (0%)    0/26 (0%)    0/24 (0%)  |  0/35 (0%)    0/26 (0%)    0/33 (0%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |   532          ---          ---          ---       |   ---          ---          ---          475       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.325N     P=0.566N     P=0.506N     P=0.549N   |  P=0.042 *      (e)          (e)        P=0.211    |
|INCIDENTAL TUMOR       |  P=0.291N     P=0.454N     P=0.493N     P=0.460N   |  P=0.050 *      (e)          (e)        P=0.245    |
|LOGISTIC REGRESSION    |  P=0.316N     P=0.532N     P=0.505N     P=0.526N   |  P=0.046 *      (e)          (e)        P=0.238    |
|COCHRAN-ARMITAGE       |  P=0.306N                                          |  P=0.046 *                                         |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   5
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Tissue NOS                                                                                                                       |
|     Lipoma                                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    3/60 (5%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   3.4%         0.0%        11.5%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    3/26 (12%)   0/24 (0%)  |  0/35 (0%)    0/26 (0%)    0/33 (0%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   552 (T)      ---          552 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.517N     P=0.607N     P=0.265      P=0.538N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.517N     P=0.607N     P=0.265      P=0.538N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.517N     P=0.607N     P=0.265      P=0.538N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.500N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  4/60 (7%)    2/60 (3%)    6/60 (10%)   1/60 (2%)  |
|ADJUSTED (b)           |                                                    |  10.4%         6.5%        14.3%         3.7%      |
|TERMINAL (d)           |                                                    |  3/35 (9%)    1/26 (4%)    2/33 (6%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   463          500          401          552 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.277N     P=0.448N     P=0.368      P=0.245N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.226N     P=0.388N     P=0.379      P=0.224N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.231N     P=0.359N     P=0.375      P=0.186N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.235N                                          |
|FISHER EXACT           |                                                    |               P=0.340N     P=0.372      P=0.182N   |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   6
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/60 (2%)    2/60 (3%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |                                                    |   2.0%         5.9%         3.0%         9.1%      |
|TERMINAL (d)           |                                                    |  0/35 (0%)    1/26 (4%)    1/33 (3%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   475          482          552 (T)      517       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.218      P=0.461      P=0.754      P=0.283    |
|INCIDENTAL TUMOR       |                                                    |  P=0.262      P=0.527      P=0.758N     P=0.372    |
|LOGISTIC REGRESSION    |                                                    |  P=0.240      P=0.502      P=0.762      P=0.305    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.238                                           |
|FISHER EXACT           |                                                    |               P=0.500      P=0.752N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/60 (8%)    4/60 (7%)    7/60 (12%)   4/60 (7%)  |
|ADJUSTED (b)           |                                                    |  12.2%        12.2%        17.1%        12.6%      |
|TERMINAL (d)           |                                                    |  3/35 (9%)    2/26 (8%)    3/33 (9%)    2/27 (7%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   463          482          401          517       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.556N     P=0.615N     P=0.375      P=0.586N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.473N     P=0.529N     P=0.390      P=0.499N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.495N     P=0.513N     P=0.383      P=0.505N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.500N                                          |
|FISHER EXACT           |                                                    |               P=0.500N     P=0.381      P=0.500N   |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   7
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |   0.0%         0.0%         0.0%         5.7%      |
|TERMINAL (d)           |                                                    |  0/35 (0%)    0/26 (0%)    0/33 (0%)    1/27 (4%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   ---          ---          ---          475       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.042 *      (e)          (e)        P=0.211    |
|INCIDENTAL TUMOR       |                                                    |  P=0.050 *      (e)          (e)        P=0.245    |
|LOGISTIC REGRESSION    |                                                    |  P=0.046 *      (e)          (e)        P=0.238    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.046 *                                         |
|FISHER EXACT           |                                                    |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    3/60 (5%)    2/60 (3%)  |  0/60 (0%)    1/60 (2%)    3/60 (5%)    3/60 (5%)  |
|ADJUSTED (b)           |   3.4%         0.0%        11.5%         6.6%      |   0.0%         1.9%         8.5%        11.1%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    3/26 (12%)   1/24 (4%)  |  0/35 (0%)    0/26 (0%)    1/33 (3%)    3/27 (11%) |
|FIRST INCIDENCE (DAYS) |   552 (T)      ---          552 (T)      482       |   ---          450          545          552 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.225      P=0.607N     P=0.265      P=0.433    |  P=0.052      P=0.500      P=0.121      P=0.079    |
|INCIDENTAL TUMOR       |  P=0.239      P=0.607N     P=0.265      P=0.479    |  P=0.046 *    P=0.553      P=0.242      P=0.079    |
|LOGISTIC REGRESSION    |  P=0.206      P=0.607N     P=0.265      P=0.461    |  P=0.067      P=0.494      P=0.126      P=0.079    |
|COCHRAN-ARMITAGE       |  P=0.242                                           |  P=0.068                                           |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500    |               P=0.500      P=0.122      P=0.122    |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   8
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    3/60 (5%)    2/60 (3%)  |  0/60 (0%)    1/60 (2%)    3/60 (5%)    3/60 (5%)  |
|ADJUSTED (b)           |   3.4%         0.0%        11.5%         6.6%      |   0.0%         1.9%         8.5%        11.1%      |
|TERMINAL (d)           |  1/29 (3%)    0/17 (0%)    3/26 (12%)   1/24 (4%)  |  0/35 (0%)    0/26 (0%)    1/33 (3%)    3/27 (11%) |
|FIRST INCIDENCE (DAYS) |   552 (T)      ---          552 (T)      482       |   ---          450          545          552 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.225      P=0.607N     P=0.265      P=0.433    |  P=0.052      P=0.500      P=0.121      P=0.079    |
|INCIDENTAL TUMOR       |  P=0.239      P=0.607N     P=0.265      P=0.479    |  P=0.046 *    P=0.553      P=0.242      P=0.079    |
|LOGISTIC REGRESSION    |  P=0.206      P=0.607N     P=0.265      P=0.461    |  P=0.067      P=0.494      P=0.126      P=0.079    |
|COCHRAN-ARMITAGE       |  P=0.242                                           |  P=0.068                                           |
|FISHER EXACT           |               P=0.500N     P=0.309      P=0.500    |               P=0.500      P=0.122      P=0.122    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    5/60 (8%)    2/60 (3%)  |  4/60 (7%)    2/60 (3%)    5/60 (8%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.3%        10.4%        15.3%         5.1%      |   9.4%         4.0%        13.8%         4.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    3/26 (12%)   0/24 (0%)  |  2/35 (6%)    0/26 (0%)    3/33 (9%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   423          442          362          437       |   373          449          507          463       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.543      P=0.389      P=0.200      P=0.651    |  P=0.408N     P=0.391N     P=0.487      P=0.379N   |
|INCIDENTAL TUMOR       |  P=0.568N     P=0.467      P=0.216      P=0.657N   |  P=0.346N     P=0.302N     P=0.639      P=0.278N   |
|LOGISTIC REGRESSION    |  P=0.579N     P=0.501      P=0.219      P=0.686N   |  P=0.371N     P=0.333N     P=0.505      P=0.338N   |
|COCHRAN-ARMITAGE       |  P=0.579                                           |  P=0.368N                                          |
|FISHER EXACT           |               P=0.500      P=0.219      P=0.691N   |               P=0.340N     P=0.500      P=0.340N   |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE   9
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    5/60 (8%)    2/60 (3%)  |  4/60 (7%)    2/60 (3%)    5/60 (8%)    2/60 (3%)  |
|ADJUSTED (b)           |   5.3%        10.4%        15.3%         5.1%      |   9.4%         4.0%        13.8%         4.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/17 (6%)    3/26 (12%)   0/24 (0%)  |  2/35 (6%)    0/26 (0%)    3/33 (9%)    0/27 (0%)  |
|FIRST INCIDENCE (DAYS) |   423          442          362          437       |   373          449          507          463       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.543      P=0.389      P=0.200      P=0.651    |  P=0.408N     P=0.391N     P=0.487      P=0.379N   |
|INCIDENTAL TUMOR       |  P=0.568N     P=0.467      P=0.216      P=0.657N   |  P=0.346N     P=0.302N     P=0.639      P=0.278N   |
|LOGISTIC REGRESSION    |  P=0.579N     P=0.501      P=0.219      P=0.686N   |  P=0.371N     P=0.333N     P=0.505      P=0.338N   |
|COCHRAN-ARMITAGE       |  P=0.579                                           |  P=0.368N                                          |
|FISHER EXACT           |               P=0.500      P=0.219      P=0.691N   |               P=0.340N     P=0.500      P=0.340N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 13/60 (22%)  23/60 (38%)  22/60 (37%)  12/60 (20%) | 15/60 (25%)  10/60 (17%)  15/60 (25%)  14/60 (23%) |
|ADJUSTED (b)           |  38.4%        76.6%        60.6%        38.3%      |  34.1%        28.8%        34.8%        37.5%      |
|TERMINAL (d)           |  9/29 (31%)  11/17 (65%)  13/26 (50%)   7/24 (29%) |  9/35 (26%)   4/26 (15%)   8/33 (24%)   7/27 (26%) |
|FIRST INCIDENCE (DAYS) |   409          438          435          442       |   370          449          401          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.386N     P<0.001 **   P=0.033 *    P=0.474    |  P=0.380      P=0.372N     P=0.554      P=0.489    |
|INCIDENTAL TUMOR       |  P=0.297N     P=0.007 **   P=0.038 *    P=0.556N   |  P=0.502      P=0.148N     P=0.580N     P=0.495N   |
|LOGISTIC REGRESSION    |  P=0.355N     P=0.007 **   P=0.040 *    P=0.548    |  P=0.484      P=0.194N     P=0.579      P=0.500N   |
|COCHRAN-ARMITAGE       |  P=0.266N                                          |  P=0.479                                           |
|FISHER EXACT           |               P=0.036 *    P=0.054      P=0.500N   |               P=0.184N     P=0.583N     P=0.500N   |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE  10
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |   0MG/KG       40MG/KG      80MG/KG      160MG/KG  |
|                       |   VM           LM           MM           HM        |   VF           LF           MF           HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/60 (15%)  13/60 (22%)  14/60 (23%)  13/60 (22%) | 13/60 (22%)   8/60 (13%)  16/60 (27%)  17/60 (28%) |
|ADJUSTED (b)           |  28.0%        44.6%        36.9%        41.6%      |  30.9%        18.2%        36.0%        46.6%      |
|TERMINAL (d)           |  7/29 (24%)   5/17 (29%)   6/26 (23%)   8/24 (33%) |  8/35 (23%)   1/26 (4%)    7/33 (21%)  10/27 (37%) |
|FIRST INCIDENCE (DAYS) |   423          442          293          427       |   373          375          427          463       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.190      P=0.051      P=0.148      P=0.124    |  P=0.070      P=0.300N     P=0.331      P=0.140    |
|INCIDENTAL TUMOR       |  P=0.264      P=0.112      P=0.161      P=0.184    |  P=0.114      P=0.150N     P=0.423      P=0.237    |
|LOGISTIC REGRESSION    |  P=0.218      P=0.156      P=0.172      P=0.159    |  P=0.097      P=0.166N     P=0.349      P=0.259    |
|COCHRAN-ARMITAGE       |  P=0.249                                           |  P=0.096                                           |
|FISHER EXACT           |               P=0.240      P=0.177      P=0.240    |               P=0.168N     P=0.335      P=0.264    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/60 (33%)  33/60 (55%)  33/60 (55%)  21/60 (35%) | 25/60 (42%)  16/60 (27%)  28/60 (47%)  26/60 (43%) |
|ADJUSTED (b)           |  57.7%        87.7%        79.1%        58.7%      |  52.0%        39.9%        56.8%        63.9%      |
|TERMINAL (d)           | 15/29 (52%)  13/17 (76%)  18/26 (69%)  11/24 (46%) | 14/35 (40%)   5/26 (19%)  13/33 (39%)  14/27 (52%) |
|FIRST INCIDENCE (DAYS) |   409          438          293          427       |   120          375          401          411       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.503      P<0.001 **   P=0.008 **   P=0.250    |  P=0.152      P=0.228N     P=0.356      P=0.273    |
|INCIDENTAL TUMOR       |  P=0.407N     P=0.001 **   P=0.007 **   P=0.424    |  P=0.245      P=0.039N*    P=0.418      P=0.475    |
|LOGISTIC REGRESSION    |  P=0.479N     P=0.002 **   P=0.009 **   P=0.350    |  P=0.218      P=0.058N     P=0.317      P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.388N                                          |  P=0.217                                           |
|FISHER EXACT           |               P=0.013 *    P=0.013 *    P=0.500    |               P=0.062N     P=0.357      P=0.500    |
|=================================================================================================================================|
         DATE: 09/13/94                     EXPERIMENT: 05098 TEST: 01                                                 PAGE  11
                                    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN 35(  ) -- P-NITROPHENOL
                                                 TERMINAL SACRIFICE AT 79 WEEKS
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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).