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TDMS Study 05119-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                  DIETHYLPHTHALATE/DIMETHYLPHTHALATE                          DATE: 05/20/95       
EXPERIMENT: 05119 TEST: 01                                                                                     TIME: 02:44:25       
TEST TYPE:  INIT/PROMOT                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 10112F       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                  DIETHYLPHTHALATE/DIMETHYLPHTHALATE                          DATE: 05/20/95       
EXPERIMENT: 05119 TEST: 01                                                                                     TIME: 02:44:25       
TEST TYPE:  INIT/PROMOT                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 10112F       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         


                                                    CD(1 CRL MICE OUTBRED CHARLES RIVER)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    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                                  DIETHYLPHTHALATE/DIMETHYLPHTHALATE                          DATE: 05/20/95       
EXPERIMENT: 05119 TEST: 01                                                                                     TIME: 02:44:25       
TEST TYPE:  INIT/PROMOT                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 10112F       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                               IN THE ANALYSIS OF THE STUDY OF DIETHYLPHTHALATE/DIMETHYLPHTHALATE
              ====================================================================================================
                                                           MALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
              Skin                          Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Papilloma
                                            Squamous Cell Carcinoma
                                            Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
              Tissue NOS                    Lipoma
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Adrenal Cortex                                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     6/98 (6%)       0/1 (0%)        0/0 (0%)         |
|ADJUSTED (b)           |      7.8%            0.0%            0.0%            |
|TERMINAL (d)           |     6/77 (8%)       0/0             0/0              |
|FIRST INCIDENCE (DAYS) |      387 (T)         ---             ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |       (e)             (e)             (e)            |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)            |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)            |
|COCHRAN-ARMITAGE       |     P=1.000N                                         |
|FISHER EXACT           |                     P=0.939N        P=1.000N         |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    19/120 (16%)     7/32 (22%)     11/40 (28%)       |
|ADJUSTED (b)           |     21.6%           41.2%           53.8%            |
|TERMINAL (d)           |    19/88 (22%)      7/17 (41%)      9/17 (53%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         368             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.003 **      P=0.081         P=0.003 **       |
|INCIDENTAL TUMOR       |     P=0.003 **      P=0.081         P=0.001 **       |
|LOGISTIC REGRESSION    |     P=0.004 **      P=0.081         P=0.002 **       |
|COCHRAN-ARMITAGE       |     P=0.104                                          |
|FISHER EXACT           |                     P=0.286         P=0.083          |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     3/120 (3%)      1/32 (3%)       2/40 (5%)        |
|ADJUSTED (b)           |      3.4%            5.9%           11.8%            |
|TERMINAL (d)           |     3/88 (3%)       1/17 (6%)       2/17 (12%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         387 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.212         P=0.581         P=0.196          |
|INCIDENTAL TUMOR       |     P=0.212         P=0.581         P=0.196          |
|LOGISTIC REGRESSION    |     P=0.212         P=0.581         P=0.196          |
|COCHRAN-ARMITAGE       |     P=0.399                                          |
|FISHER EXACT           |                     P=0.616         P=0.367          |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    22/120 (18%)     8/32 (25%)     13/40 (33%)       |
|ADJUSTED (b)           |     25.0%           47.1%           65.4%            |
|TERMINAL (d)           |    22/88 (25%)      8/17 (47%)     11/17 (65%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         368             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P<0.001 **      P=0.061         P<0.001 **       |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.061         P<0.001 **       |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.061         P<0.001 **       |
|COCHRAN-ARMITAGE       |     P=0.066                                          |
|FISHER EXACT           |                     P=0.271         P=0.052          |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    22/120 (18%)     8/32 (25%)     13/40 (33%)       |
|ADJUSTED (b)           |     25.0%           47.1%           65.4%            |
|TERMINAL (d)           |    22/88 (25%)      8/17 (47%)     11/17 (65%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         368             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P<0.001 **      P=0.061         P<0.001 **       |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.061         P<0.001 **       |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.061         P<0.001 **       |
|COCHRAN-ARMITAGE       |     P=0.066                                          |
|FISHER EXACT           |                     P=0.271         P=0.052          |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    19/199 (10%)    15/199 (8%)     10/197 (5%)       |
|ADJUSTED (b)           |     14.0%           10.9%            9.9%            |
|TERMINAL (d)           |    18/135 (13%)    11/131 (8%)     10/101 (10%)      |
|FIRST INCIDENCE (DAYS) |      380             330             387 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.278N        P=0.328N        P=0.222N         |
|INCIDENTAL TUMOR       |     P=0.225N        P=0.329N        P=0.225N         |
|LOGISTIC REGRESSION    |     P=0.228N        P=0.331N        P=0.198N         |
|COCHRAN-ARMITAGE       |     P=0.088N                                         |
|FISHER EXACT           |                     P=0.296N        P=0.064N         |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma                                           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     4/199 (2%)      2/199 (1%)      1/197 (1%)       |
|ADJUSTED (b)           |      2.9%            1.5%            1.0%            |
|TERMINAL (d)           |     3/135 (2%)      2/131 (2%)      1/101 (1%)       |
|FIRST INCIDENCE (DAYS) |      338             387 (T)         387 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.353N        P=0.354N        P=0.275N         |
|INCIDENTAL TUMOR       |     P=0.309N        P=0.341N        P=0.220N         |
|LOGISTIC REGRESSION    |     P=0.324N        P=0.355N        P=0.247N         |
|COCHRAN-ARMITAGE       |     P=0.254N                                         |
|FISHER EXACT           |                     P=0.343N        P=0.189N         |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    22/199 (11%)    17/199 (9%)     11/197 (6%)       |
|ADJUSTED (b)           |     16.0%           12.4%           10.9%            |
|TERMINAL (d)           |    20/135 (15%)    13/131 (10%)    11/101 (11%)      |
|FIRST INCIDENCE (DAYS) |      338             330             387 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.218N        P=0.282N        P=0.159N         |
|INCIDENTAL TUMOR       |     P=0.163N        P=0.278N        P=0.145N         |
|LOGISTIC REGRESSION    |     P=0.169N        P=0.285N        P=0.132N         |
|COCHRAN-ARMITAGE       |     P=0.056N                                         |
|FISHER EXACT           |                     P=0.250N        P=0.036N*        |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal    |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoep|thelioma
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     5/199 (3%)     31/199 (16%)     8/198 (4%)       |
|ADJUSTED (b)           |      3.6%           19.7%            7.6%            |
|TERMINAL (d)           |     4/135 (3%)     15/131 (11%)     7/102 (7%)       |
|FIRST INCIDENCE (DAYS) |      323             141             348             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.081N        P<0.001 **      P=0.144          |
|INCIDENTAL TUMOR       |     P=0.014N*       P<0.001 **      P=0.195          |
|LOGISTIC REGRESSION    |     P=0.019N*       P<0.001 **      P=0.173          |
|COCHRAN-ARMITAGE       |     P=0.021N*                                        |
|FISHER EXACT           |                     P<0.001 **      P=0.284          |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Papilloma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     5/199 (3%)     27/199 (14%)     7/198 (4%)       |
|ADJUSTED (b)           |      3.6%           17.3%            6.6%            |
|TERMINAL (d)           |     4/135 (3%)     13/131 (10%)     6/102 (6%)       |
|FIRST INCIDENCE (DAYS) |      323             141             348             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.092N        P<0.001 **      P=0.221          |
|INCIDENTAL TUMOR       |     P=0.020N*       P<0.001 **      P=0.290          |
|LOGISTIC REGRESSION    |     P=0.028N*       P<0.001 **      P=0.259          |
|COCHRAN-ARMITAGE       |     P=0.028N*                                        |
|FISHER EXACT           |                     P<0.001 **      P=0.382          |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     0/199 (0%)     11/199 (6%)      1/198 (1%)       |
|ADJUSTED (b)           |      0.0%            7.4%            1.0%            |
|TERMINAL (d)           |     0/135 (0%)      5/131 (4%)      1/102 (1%)       |
|FIRST INCIDENCE (DAYS) |      ---             259             387 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.107N        P=0.001 **      P=0.444          |
|INCIDENTAL TUMOR       |     P=0.041N*       P=0.002 **      P=0.444          |
|LOGISTIC REGRESSION    |     P=0.058N        P=0.001 **      P=0.444          |
|COCHRAN-ARMITAGE       |     P=0.062N                                         |
|FISHER EXACT           |                     P<0.001 **      P=0.499          |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacan|homa
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     5/199 (3%)     31/199 (16%)     8/198 (4%)       |
|ADJUSTED (b)           |      3.6%           19.7%            7.6%            |
|TERMINAL (d)           |     4/135 (3%)     15/131 (11%)     7/102 (7%)       |
|FIRST INCIDENCE (DAYS) |      323             141             348             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.081N        P<0.001 **      P=0.144          |
|INCIDENTAL TUMOR       |     P=0.014N*       P<0.001 **      P=0.195          |
|LOGISTIC REGRESSION    |     P=0.019N*       P<0.001 **      P=0.173          |
|COCHRAN-ARMITAGE       |     P=0.021N*                                        |
|FISHER EXACT           |                     P<0.001 **      P=0.284          |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|Tissue NOS                                                                    |
|     Lipoma                                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     4/199 (2%)     11/199 (6%)     10/198 (5%)       |
|ADJUSTED (b)           |      3.0%            8.4%            9.6%            |
|TERMINAL (d)           |     4/135 (3%)     11/131 (8%)      9/102 (9%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         357             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.119         P=0.049 *       P=0.028 *        |
|INCIDENTAL TUMOR       |     P=0.135         P=0.049 *       P=0.035 *        |
|LOGISTIC REGRESSION    |     P=0.140         P=0.049 *       P=0.034 *        |
|COCHRAN-ARMITAGE       |     P=0.302                                          |
|FISHER EXACT           |                     P=0.056         P=0.084          |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Hemangiosarcoma or Hemangioma                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     2/199 (1%)      1/199 (1%)      1/198 (1%)       |
|ADJUSTED (b)           |      1.5%            0.8%            0.8%            |
|TERMINAL (d)           |     2/135 (1%)      1/131 (1%)      0/102 (0%)       |
|FIRST INCIDENCE (DAYS) |      387 (T)         387 (T)         320             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.660N        P=0.510N        P=0.585N         |
|INCIDENTAL TUMOR       |     P=0.597N        P=0.510N        P=0.503N         |
|LOGISTIC REGRESSION    |     P=0.625N        P=0.510N        P=0.549N         |
|COCHRAN-ARMITAGE       |     P=0.572N                                         |
|FISHER EXACT           |                     P=0.500N        P=0.502N         |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma And Histiocytic Sarcoma                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     2/199 (1%)      1/199 (1%)      1/198 (1%)       |
|ADJUSTED (b)           |      1.2%            0.6%            0.7%            |
|TERMINAL (d)           |     0/135 (0%)      0/131 (0%)      0/102 (0%)       |
|FIRST INCIDENCE (DAYS) |      253             304             273             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.633N        P=0.515N        P=0.563N         |
|INCIDENTAL TUMOR       |     P=0.391N        P=0.448N        P=0.316N         |
|LOGISTIC REGRESSION    |     P=0.501N        P=0.475N        P=0.420N         |
|COCHRAN-ARMITAGE       |     P=0.572N                                         |
|FISHER EXACT           |                     P=0.500N        P=0.502N         |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferenti|ted
|     Cell Type                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     2/199 (1%)      1/199 (1%)      1/198 (1%)       |
|ADJUSTED (b)           |      1.2%            0.6%            0.7%            |
|TERMINAL (d)           |     0/135 (0%)      0/131 (0%)      0/102 (0%)       |
|FIRST INCIDENCE (DAYS) |      253             304             273             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.633N        P=0.515N        P=0.563N         |
|INCIDENTAL TUMOR       |     P=0.391N        P=0.448N        P=0.316N         |
|LOGISTIC REGRESSION    |     P=0.501N        P=0.475N        P=0.420N         |
|COCHRAN-ARMITAGE       |     P=0.572N                                         |
|FISHER EXACT           |                     P=0.500N        P=0.502N         |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE   9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    47/199 (24%)    60/199 (30%)    33/198 (17%)      |
|ADJUSTED (b)           |     34.2%           39.3%           30.5%            |
|TERMINAL (d)           |    45/135 (33%)    42/131 (32%)    28/102 (27%)      |
|FIRST INCIDENCE (DAYS) |      323             141             320             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.104N        P=0.063         P=0.392N         |
|INCIDENTAL TUMOR       |     P=0.029N*       P=0.075         P=0.325N         |
|LOGISTIC REGRESSION    |     P=0.029N*       P=0.063         P=0.299N         |
|COCHRAN-ARMITAGE       |     P=0.004N**                                       |
|FISHER EXACT           |                     P=0.087         P=0.054N         |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    14/199 (7%)     14/199 (7%)      5/198 (3%)       |
|ADJUSTED (b)           |      9.8%            9.6%            4.6%            |
|TERMINAL (d)           |    11/135 (8%)      8/131 (6%)      4/102 (4%)       |
|FIRST INCIDENCE (DAYS) |      253             259             273             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.065N        P=0.542         P=0.095N         |
|INCIDENTAL TUMOR       |     P=0.020N*       P=0.548N        P=0.048N*        |
|LOGISTIC REGRESSION    |     P=0.026N*       P=0.534         P=0.057N         |
|COCHRAN-ARMITAGE       |     P=0.019N*                                        |
|FISHER EXACT           |                     P=0.577N        P=0.029N*        |
|==============================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05119 TEST: 01                                                 PAGE  10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE CD(1 CRL MICE OUTBRED CHARLES RIVER) -- DIETHYLPHTHALATE/DIMETHYLPHTHALATE
                       TERMINAL SACRIFICE AT 56 WEEKS
|==============================================================================|
|DOSE                   |      ACETONE/        DMBA/DMP        DMP/ACET        |
|                       |      ACETONE                         ONE             |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    59/199 (30%)    65/199 (33%)    37/198 (19%)      |
|ADJUSTED (b)           |     41.9%           42.1%           33.8%            |
|TERMINAL (d)           |    54/135 (40%)    45/131 (34%)    31/102 (30%)      |
|FIRST INCIDENCE (DAYS) |      253             141             273             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.055N        P=0.231         P=0.159N         |
|INCIDENTAL TUMOR       |     P=0.009N**      P=0.278         P=0.088N         |
|LOGISTIC REGRESSION    |     P=0.009N**      P=0.239         P=0.082N         |
|COCHRAN-ARMITAGE       |     P<0.001N**                                       |
|FISHER EXACT           |                     P=0.294         P=0.007N**       |
|==============================================================================|
 (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).