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TDMS Study 05106-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95       
EXPERIMENT: 05106 TEST: 01                                                                                     TIME: 20:59:37       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 60048B       
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                                   DATE: 05/19/95       
EXPERIMENT: 05106 TEST: 01                                                                                     TIME: 20:59:37       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 60048B       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         


                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Gland
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95       
EXPERIMENT: 05106 TEST: 01                                                                                     TIME: 20:59:37       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 60048B       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF DIETHYLPHTHALATE
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Adrenal Medulla               Pheochromocytoma Benign
                                            Pheochromocytoma: Benign, Complex, Malignant, NOS
              All Organs                    Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Clitoral/Preputial Gland      Adenoma
                                            Carcinoma or Adenoma
              Mammary Gland                 Fibroadenoma
                                            Fibroma, Fibroadenoma or Adenoma
                                            Fibroma, Fibroadenoma, Carcinoma, or Adenoma
              Uterus                        Polyp Stromal
                                            Sarcoma Stromal or Polyp Stromal
              All Organs                    Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/59 (0%)       1/50 (2%)       0/59 (0%)      |     4/60 (7%)       4/50 (8%)       7/60 (12%)     |
|ADJUSTED (b)           |      0.0%           16.7%            0.0%          |     12.8%           12.7%           25.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |     3/30 (10%)      3/28 (11%)      4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |      ---             734 (T)         ---           |      730             567             559           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.658N        P=0.581           (e)          |     P=0.099         P=0.607         P=0.143        |
|INCIDENTAL TUMOR       |     P=0.658N        P=0.581           (e)          |     P=0.122         P=0.614         P=0.163        |
|LOGISTIC REGRESSION    |     P=0.658N        P=0.581           (e)          |     P=0.126         P=0.594         P=0.165        |
|COCHRAN-ARMITAGE       |     P=0.695N                                       |     P=0.217                                        |
|FISHER EXACT           |                     P=0.459           (e)          |                     P=0.536         P=0.264        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/59 (25%)      9/50 (18%)      8/57 (14%)     |     3/59 (5%)       1/50 (2%)       1/60 (2%)      |
|ADJUSTED (b)           |     76.2%           61.3%           50.0%          |     10.0%            3.6%            4.3%          |
|INTERIM SACRIFICE 1 (c)|     1/10 (10%)      0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     2/4 (50%)       2/6 (33%)       1/6 (17%)      |     3/30 (10%)      1/28 (4%)       1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      456 (I)         616             534           |      734 (T)         734 (T)         734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.039N*       P=0.052N        P=0.032N*      |     P=0.354N        P=0.329N        P=0.403N       |
|INCIDENTAL TUMOR       |     P=0.076N        P=0.098N        P=0.088N       |     P=0.354N        P=0.329N        P=0.403N       |
|LOGISTIC REGRESSION    |     P=0.058N        P=0.088N        P=0.056N       |     P=0.354N        P=0.329N        P=0.403N       |
|COCHRAN-ARMITAGE       |     P=0.092N                                       |     P=0.261N                                       |
|FISHER EXACT           |                     P=0.243N        P=0.095N       |                     P=0.374N        P=0.303N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/59 (25%)     10/50 (20%)      9/57 (16%)     |     4/59 (7%)       2/50 (4%)       1/60 (2%)      |
|ADJUSTED (b)           |     76.2%           62.3%           60.0%          |     13.3%            5.7%            4.3%          |
|INTERIM SACRIFICE 1 (c)|     1/10 (10%)      0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     2/4 (50%)       2/6 (33%)       2/6 (33%)      |     4/30 (13%)      1/28 (4%)       1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      456 (I)         580             534           |      734 (T)         551             734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.060N        P=0.084N        P=0.048N*      |     P=0.217N        P=0.367N        P=0.265N       |
|INCIDENTAL TUMOR       |     P=0.117N        P=0.158N        P=0.124N       |     P=0.191N        P=0.364N        P=0.265N       |
|LOGISTIC REGRESSION    |     P=0.090N        P=0.145N        P=0.086N       |     P=0.193N        P=0.381N        P=0.265N       |
|COCHRAN-ARMITAGE       |     P=0.136N                                       |     P=0.144N                                       |
|FISHER EXACT           |                     P=0.330N        P=0.147N       |                     P=0.421N        P=0.177N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/44 (0%)       1/46 (2%)       0/54 (0%)      |     5/53 (9%)       0/39 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%           16.7%            0.0%          |     15.2%            0.0%            8.7%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |     3/29 (10%)      0/28 (0%)       2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      ---             734 (T)         ---           |      650             ---             734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.658N        P=0.581           (e)          |     P=0.325N        P=0.042N*       P=0.330N       |
|INCIDENTAL TUMOR       |     P=0.658N        P=0.581           (e)          |     P=0.355N        P=0.045N*       P=0.367N       |
|LOGISTIC REGRESSION    |     P=0.658N        P=0.581           (e)          |     P=0.311N        P=0.044N*       P=0.315N       |
|COCHRAN-ARMITAGE       |     P=0.670N                                       |     P=0.244N                                       |
|FISHER EXACT           |                     P=0.511           (e)          |                     P=0.058N        P=0.243N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/44 (2%)       1/46 (2%)       2/54 (4%)      |     2/53 (4%)       1/39 (3%)       2/50 (4%)      |
|ADJUSTED (b)           |      2.5%            5.6%            5.9%          |      6.9%            3.6%            8.7%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     2/29 (7%)       1/28 (4%)       2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      549             666             542           |      734 (T)         734 (T)         734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.392         P=0.742N        P=0.501        |     P=0.509         P=0.512N        P=0.610        |
|INCIDENTAL TUMOR       |     P=0.499         P=0.725N        P=0.656        |     P=0.509         P=0.512N        P=0.610        |
|LOGISTIC REGRESSION    |     P=0.464         P=0.759N        P=0.562        |     P=0.509         P=0.512N        P=0.610        |
|COCHRAN-ARMITAGE       |     P=0.465                                        |     P=0.591                                        |
|FISHER EXACT           |                     P=0.742N        P=0.577        |                     P=0.614N        P=0.669        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/44 (2%)       2/46 (4%)       2/54 (4%)      |     7/53 (13%)      1/39 (3%)       4/50 (8%)      |
|ADJUSTED (b)           |      2.5%           21.3%            5.9%          |     21.7%            3.6%           17.4%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |     5/29 (17%)      1/28 (4%)       4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |      549             666             542           |      650             734 (T)         734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.474         P=0.565         P=0.501        |     P=0.452N        P=0.040N*       P=0.415N       |
|INCIDENTAL TUMOR       |     P=0.573         P=0.583         P=0.656        |     P=0.478N        P=0.043N*       P=0.449N       |
|LOGISTIC REGRESSION    |     P=0.531         P=0.559         P=0.562        |     P=0.446N        P=0.043N*       P=0.411N       |
|COCHRAN-ARMITAGE       |     P=0.532                                        |     P=0.323N                                       |
|FISHER EXACT           |                     P=0.517         P=0.577        |                     P=0.074N        P=0.298N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       1/50 (2%)       2/60 (3%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            9.1%           20.1%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        1/6 (17%)      |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             704             645           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.239         P=0.621         P=0.312        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.212         P=0.547         P=0.306        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.201         P=0.560         P=0.278        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.189                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.455         P=0.248        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large: Colon/Rectum                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/50 (0%)       2/60 (3%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           11.2%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             534           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.119           (e)           P=0.311        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.144           (e)           P=0.315        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.100           (e)           P=0.245        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.101                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.248        |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)     11/50 (22%)      7/49 (14%)     |     3/50 (6%)       1/50 (2%)       3/50 (6%)      |
|ADJUSTED (b)           |     49.4%           78.0%           41.1%          |      9.2%            3.6%           13.0%          |
|INTERIM SACRIFICE 1 (c)|     1/1 (100%)      0/0             0/0            |     0/0             0/0             0/0            |
|TERMINAL (d)           |     1/4 (25%)       4/6 (67%)       1/6 (17%)      |     2/30 (7%)       1/28 (4%)       3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         620             533           |      679             734 (T)         734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.416N        P=0.343         P=0.562N       |     P=0.422         P=0.341N        P=0.534        |
|INCIDENTAL TUMOR       |     P=0.494N        P=0.242         P=0.536        |     P=0.423         P=0.325N        P=0.539        |
|LOGISTIC REGRESSION    |     P=0.412N        P=0.320         P=0.583N       |     P=0.427         P=0.333N        P=0.544        |
|COCHRAN-ARMITAGE       |     P=0.496N                                       |     P=0.541                                        |
|FISHER EXACT           |                     P=0.218         P=0.597        |                     P=0.309N        P=0.661N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       0/49 (0%)      |     2/50 (4%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%           10.0%            0.0%          |      6.7%           10.7%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/1 (0%)        0/0             0/0            |     0/0             0/0             0/0            |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     2/30 (7%)       3/28 (11%)      0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             716             ---           |      734 (T)         734 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.650N        P=0.638           (e)          |     P=0.226N        P=0.468         P=0.298N       |
|INCIDENTAL TUMOR       |     P=0.686N        P=0.547           (e)          |     P=0.226N        P=0.468         P=0.298N       |
|LOGISTIC REGRESSION    |     P=0.668N        P=0.573           (e)          |     P=0.226N        P=0.468         P=0.298N       |
|COCHRAN-ARMITAGE       |     P=0.708N                                       |     P=0.165N                                       |
|FISHER EXACT           |                     P=0.500           (e)          |                     P=0.500         P=0.247N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)     12/50 (24%)      7/49 (14%)     |     5/50 (10%)      4/50 (8%)       3/50 (6%)      |
|ADJUSTED (b)           |     49.4%           80.2%           41.1%          |     15.7%           14.3%           13.0%          |
|INTERIM SACRIFICE 1 (c)|     1/1 (100%)      0/0             0/0            |     0/0             0/0             0/0            |
|TERMINAL (d)           |     1/4 (25%)       4/6 (67%)       1/6 (17%)      |     4/30 (13%)      4/28 (14%)      3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         620             533           |      679             734 (T)         734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382N        P=0.287         P=0.562N       |     P=0.463N        P=0.551N        P=0.509N       |
|INCIDENTAL TUMOR       |     P=0.464N        P=0.176         P=0.536        |     P=0.461N        P=0.539N        P=0.505N       |
|LOGISTIC REGRESSION    |     P=0.383N        P=0.246         P=0.583N       |     P=0.469N        P=0.566N        P=0.508N       |
|COCHRAN-ARMITAGE       |     P=0.474N                                       |     P=0.315N                                       |
|FISHER EXACT           |                     P=0.154         P=0.597        |                     P=0.500N        P=0.357N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/50 (0%)       1/60 (2%)      |     2/59 (3%)       0/50 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           12.5%          |      6.7%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     2/30 (7%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             722           |      734 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359           (e)           P=0.594        |     P=0.206N        P=0.253N        P=0.298N       |
|INCIDENTAL TUMOR       |     P=0.314           (e)           P=0.536        |     P=0.206N        P=0.253N        P=0.298N       |
|LOGISTIC REGRESSION    |     P=0.337           (e)           P=0.579        |     P=0.206N        P=0.253N        P=0.298N       |
|COCHRAN-ARMITAGE       |     P=0.306                                        |     P=0.170N                                       |
|FISHER EXACT           |                       (e)           P=0.500        |                     P=0.291N        P=0.244N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/50 (0%)       0/60 (0%)      |     5/60 (8%)       3/52 (6%)       3/60 (5%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     15.1%            9.0%           13.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     4/30 (13%)      1/28 (4%)       3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      465             645             734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.469N        P=0.397N        P=0.492N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.414N        P=0.335N        P=0.413N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.403N        P=0.415N        P=0.443N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.327N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.441N        P=0.359N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/50 (0%)       0/60 (0%)      |     6/60 (10%)      3/52 (6%)       3/60 (5%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     17.8%            9.0%           13.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     4/30 (13%)      1/28 (4%)       3/23 (13%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      465             645             734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.359N        P=0.285N        P=0.377N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.305N        P=0.225N        P=0.300N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.297N        P=0.293N        P=0.327N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.227N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.321N        P=0.245N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       1/50 (2%)       0/60 (0%)      |    23/60 (38%)     12/52 (23%)      7/60 (12%)     |
|ADJUSTED (b)           |      0.0%            2.9%            0.0%          |     59.9%           36.8%           24.4%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     2/9 (22%)       0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |    16/30 (53%)      8/28 (29%)      4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |      ---             597             ---           |      331             650             585           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.702N        P=0.532           (e)          |     P=0.006N**      P=0.065N        P=0.006N**     |
|INCIDENTAL TUMOR       |     P=0.769N        P=0.449           (e)          |     P=0.003N**      P=0.070N        P=0.002N**     |
|LOGISTIC REGRESSION    |     P=0.694N        P=0.458           (e)          |     P=0.002N**      P=0.042N*       P=0.001N**     |
|COCHRAN-ARMITAGE       |     P=0.694N                                       |     P<0.001N**                                     |
|FISHER EXACT           |                     P=0.455           (e)          |                     P=0.062N        P<0.001N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       1/50 (2%)       0/60 (0%)      |     0/60 (0%)       0/52 (0%)       1/60 (2%)      |
|ADJUSTED (b)           |     10.4%           16.7%            0.0%          |      0.0%            0.0%            2.3%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      520             734 (T)         ---           |      ---             ---             549           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.146N        P=0.428N        P=0.215N       |     P=0.280           (e)           P=0.478        |
|INCIDENTAL TUMOR       |     P=0.120N        P=0.459N        P=0.170N       |     P=0.370           (e)           P=0.581        |
|LOGISTIC REGRESSION    |     P=0.165N        P=0.498N        P=0.235N       |     P=0.342           (e)           P=0.527        |
|COCHRAN-ARMITAGE       |     P=0.175N                                       |     P=0.304                                        |
|FISHER EXACT           |                     P=0.569N        P=0.248N       |                       (e)           P=0.500        |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/50 (4%)       0/60 (0%)      |    24/60 (40%)     12/52 (23%)      8/60 (13%)     |
|ADJUSTED (b)           |     10.4%           19.1%            0.0%          |     61.1%           36.8%           26.2%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     2/9 (22%)       0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |    16/30 (53%)      8/28 (29%)      4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |      520             597             ---           |      331             650             549           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.145N        P=0.621N        P=0.215N       |     P=0.010N**      P=0.047N*       P=0.009N**     |
|INCIDENTAL TUMOR       |     P=0.141N        P=0.685N        P=0.170N       |     P=0.003N**      P=0.048N*       P=0.002N**     |
|LOGISTIC REGRESSION    |     P=0.164N        P=0.680         P=0.235N       |     P=0.002N**      P=0.028N*       P=0.002N**     |
|COCHRAN-ARMITAGE       |     P=0.170N                                       |     P=0.001N**                                     |
|FISHER EXACT           |                     P=0.619         P=0.248N       |                     P=0.043N*       P<0.001N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/50 (4%)       0/60 (0%)      |    27/60 (45%)     14/52 (27%)     11/60 (18%)     |
|ADJUSTED (b)           |     10.4%           19.1%            0.0%          |     67.4%           41.6%           37.8%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     2/9 (22%)       0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       0/6 (0%)       |    18/30 (60%)      9/28 (32%)      7/23 (30%)     |
|FIRST INCIDENCE (DAYS) |      520             597             ---           |      331             645             549           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.145N        P=0.621N        P=0.215N       |     P=0.020N*       P=0.039N*       P=0.016N*      |
|INCIDENTAL TUMOR       |     P=0.141N        P=0.685N        P=0.170N       |     P=0.006N**      P=0.031N*       P=0.003N**     |
|LOGISTIC REGRESSION    |     P=0.164N        P=0.680         P=0.235N       |     P=0.004N**      P=0.023N*       P=0.003N**     |
|COCHRAN-ARMITAGE       |     P=0.170N                                       |     P=0.002N**                                     |
|FISHER EXACT           |                     P=0.619         P=0.248N       |                     P=0.037N*       P=0.001N**     |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    43/54 (80%)     41/49 (84%)     46/58 (79%)     |    42/59 (71%)     33/50 (66%)     35/58 (60%)     |
|ADJUSTED (b)           |    100.0%           96.9%          100.0%          |     88.7%           76.0%           94.0%          |
|INTERIM SACRIFICE 1 (c)|     4/10 (40%)      0/0             5/9 (56%)      |     4/9 (44%)       0/1 (0%)        2/10 (20%)     |
|TERMINAL (d)           |     3/3 (100%)      5/6 (83%)       5/5 (100%)     |    25/30 (83%)     18/28 (64%)     21/23 (91%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         304             391           |      456 (I)         434             430           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.440N        P=0.219N        P=0.388N       |     P=0.460         P=0.356N        P=0.523        |
|INCIDENTAL TUMOR       |     P=0.554N        P=0.333N        P=0.555N       |     P=0.305N        P=0.197N        P=0.289N       |
|LOGISTIC REGRESSION    |     P=0.517N        P=0.525         P=0.566N       |     P=0.283N        P=0.299N        P=0.292N       |
|COCHRAN-ARMITAGE       |     P=0.496N                                       |     P=0.137N                                       |
|FISHER EXACT           |                     P=0.393         P=0.577N       |                     P=0.353N        P=0.149N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/54 (0%)       0/49 (0%)       1/58 (2%)      |     2/59 (3%)       2/50 (4%)       1/58 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            2.6%          |      5.7%            5.9%            4.2%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/1 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/3 (0%)        0/6 (0%)        0/5 (0%)       |     0/30 (0%)       1/28 (4%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             549           |      679             573             729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.285           (e)           P=0.490        |     P=0.492N        P=0.661         P=0.602N       |
|INCIDENTAL TUMOR       |     P=0.252           (e)           P=0.439        |     P=0.473N        P=0.669         P=0.630N       |
|LOGISTIC REGRESSION    |     P=0.321           (e)           P=0.512        |     P=0.449N        P=0.645         P=0.579N       |
|COCHRAN-ARMITAGE       |     P=0.314                                        |     P=0.401N                                       |
|FISHER EXACT           |                       (e)           P=0.518        |                     P=0.626         P=0.506N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    43/54 (80%)     41/49 (84%)     47/58 (81%)     |    44/59 (75%)     35/50 (70%)     36/58 (62%)     |
|ADJUSTED (b)           |    100.0%           96.9%          100.0%          |     89.4%           78.9%           94.2%          |
|INTERIM SACRIFICE 1 (c)|     4/10 (40%)      0/0             5/9 (56%)      |     4/9 (44%)       0/1 (0%)        2/10 (20%)     |
|TERMINAL (d)           |     3/3 (100%)      5/6 (83%)       5/5 (100%)     |    25/30 (83%)     19/28 (68%)     21/23 (91%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         304             391           |      456 (I)         434             430           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.491N        P=0.219N        P=0.434N       |     P=0.504         P=0.370N        P=0.558        |
|INCIDENTAL TUMOR       |     P=0.457         P=0.333N        P=0.531        |     P=0.245N        P=0.194N        P=0.252N       |
|LOGISTIC REGRESSION    |     P=0.509         P=0.525         P=0.537        |     P=0.216N        P=0.310N        P=0.231N       |
|COCHRAN-ARMITAGE       |     P=0.528                                        |     P=0.090N                                       |
|FISHER EXACT           |                     P=0.393         P=0.520        |                     P=0.375N        P=0.104N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/50 (4%)       3/60 (5%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |     12.3%           18.7%           25.2%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        1/6 (17%)       1/6 (17%)      |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      598             553             512           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.502         P=0.605N        P=0.623        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.463         P=0.684N        P=0.572        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.444         P=0.695         P=0.532        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.437                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.619         P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Papilloma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/60 (0%)       0/50 (0%)       2/60 (3%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%           10.3%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             512           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.111           (e)           P=0.303        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.144           (e)           P=0.315        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.101           (e)           P=0.241        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.101                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.248        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       1/50 (2%)       3/60 (5%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      3.6%            2.4%           25.2%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        1/6 (17%)      |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      598             553             512           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.239         P=0.734N        P=0.407        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.213         P=0.704         P=0.362        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.213         P=0.700         P=0.324        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.214                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.705         P=0.309        |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/60 (2%)       1/50 (2%)       3/60 (5%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      3.6%            2.4%           25.2%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        1/6 (17%)      |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      598             553             512           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.239         P=0.734N        P=0.407        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.213         P=0.704         P=0.362        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.213         P=0.700         P=0.324        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.214                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.705         P=0.309        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       2/50 (4%)       3/60 (5%)      |     0/60 (0%)       0/52 (0%)       1/60 (2%)      |
|ADJUSTED (b)           |      7.6%            5.3%           11.5%          |      0.0%            0.0%            3.4%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      594             560             413           |      ---             ---             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.448         P=0.659N        P=0.563        |     P=0.262           (e)           P=0.451        |
|INCIDENTAL TUMOR       |     P=0.333         P=0.601         P=0.438        |     P=0.257           (e)           P=0.455        |
|LOGISTIC REGRESSION    |     P=0.435         P=0.614         P=0.498        |     P=0.288           (e)           P=0.483        |
|COCHRAN-ARMITAGE       |     P=0.437                                        |     P=0.304                                        |
|FISHER EXACT           |                     P=0.619         P=0.500        |                       (e)           P=0.500        |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/60 (7%)       3/50 (6%)       9/59 (15%)     |                                                    |
|ADJUSTED (b)           |     34.7%           30.8%           69.1%          |                                                    |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |                                                    |
|TERMINAL (d)           |     1/4 (25%)       1/6 (17%)       3/6 (50%)      |                                                    |
|FIRST INCIDENCE (DAYS) |      578             701             519           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.124         P=0.319N        P=0.283        |                                                    |
|INCIDENTAL TUMOR       |     P=0.070         P=0.422N        P=0.161        |                                                    |
|LOGISTIC REGRESSION    |     P=0.068         P=0.399N        P=0.167        |                                                    |
|COCHRAN-ARMITAGE       |     P=0.061                                        |                                                    |
|FISHER EXACT           |                     P=0.601N        P=0.113        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/58 (5%)       2/50 (4%)       2/57 (4%)      |     0/59 (0%)       0/50 (0%)       1/60 (2%)      |
|ADJUSTED (b)           |     14.1%           10.9%            6.0%          |      0.0%            0.0%            4.3%          |
|INTERIM SACRIFICE 1 (c)|     1/10 (10%)      0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      456 (I)         665             542           |      ---             ---             734 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.424N        P=0.618N        P=0.470N       |     P=0.254           (e)           P=0.447        |
|INCIDENTAL TUMOR       |     P=0.451N        P=0.655N        P=0.546N       |     P=0.254           (e)           P=0.447        |
|LOGISTIC REGRESSION    |     P=0.454N        P=0.547N        P=0.512N       |     P=0.254           (e)           P=0.447        |
|COCHRAN-ARMITAGE       |     P=0.455N                                       |     P=0.308                                        |
|FISHER EXACT           |                     P=0.571N        P=0.508N       |                       (e)           P=0.504        |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/58 (0%)       1/50 (2%)       2/57 (4%)      |     6/59 (10%)      5/50 (10%)      2/60 (3%)      |
|ADJUSTED (b)           |      0.0%            4.0%            7.1%          |     18.9%           14.8%            7.6%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     5/30 (17%)      3/28 (11%)      1/23 (4%)      |
|FIRST INCIDENCE (DAYS) |      ---             652             538           |      656             494             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.173         P=0.577         P=0.254        |     P=0.186N        P=0.543N        P=0.231N       |
|INCIDENTAL TUMOR       |     P=0.235         P=0.547         P=0.311        |     P=0.137N        P=0.493N        P=0.229N       |
|LOGISTIC REGRESSION    |     P=0.182         P=0.510         P=0.234        |     P=0.140N        P=0.575N        P=0.208N       |
|COCHRAN-ARMITAGE       |     P=0.182                                        |     P=0.100N                                       |
|FISHER EXACT           |                     P=0.463         P=0.243        |                     P=0.616N        P=0.131N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/58 (5%)       3/50 (6%)       4/57 (7%)      |     6/59 (10%)      5/50 (10%)      3/60 (5%)      |
|ADJUSTED (b)           |     14.1%           14.5%           12.8%          |     18.9%           14.8%           11.8%          |
|INTERIM SACRIFICE 1 (c)|     1/10 (10%)      0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     5/30 (17%)      3/28 (11%)      2/23 (9%)      |
|FIRST INCIDENCE (DAYS) |      456 (I)         652             538           |      656             494             675           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.468         P=0.605         P=0.535        |     P=0.325N        P=0.543N        P=0.382N       |
|INCIDENTAL TUMOR       |     P=0.484         P=0.564         P=0.509        |     P=0.260N        P=0.493N        P=0.381N       |
|LOGISTIC REGRESSION    |     P=0.439         P=0.629         P=0.486        |     P=0.262N        P=0.575N        P=0.359N       |
|COCHRAN-ARMITAGE       |     P=0.438                                        |     P=0.188N                                       |
|FISHER EXACT           |                     P=0.588         P=0.490        |                     P=0.616N        P=0.237N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/58 (2%)       1/50 (2%)       1/57 (2%)      |     3/59 (5%)       1/50 (2%)       1/60 (2%)      |
|ADJUSTED (b)           |     25.0%            7.7%            5.9%          |      7.3%            3.6%            2.4%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     1/4 (25%)       0/6 (0%)        0/6 (0%)       |     1/30 (3%)       1/28 (4%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      734 (T)         701             667           |      465             734 (T)         569           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.622N        P=0.643N        P=0.709N       |     P=0.320N        P=0.326N        P=0.352N       |
|INCIDENTAL TUMOR       |     P=0.629N        P=0.688N        P=0.694N       |     P=0.195N        P=0.260N        P=0.174N       |
|LOGISTIC REGRESSION    |     P=0.637N        P=0.685N        P=0.713N       |     P=0.225N        P=0.408N        P=0.250N       |
|COCHRAN-ARMITAGE       |     P=0.674N                                       |     P=0.261N                                       |
|FISHER EXACT           |                     P=0.714         P=0.748        |                     P=0.374N        P=0.303N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/58 (3%)       1/50 (2%)       1/57 (2%)      |     3/59 (5%)       1/50 (2%)       1/60 (2%)      |
|ADJUSTED (b)           |     28.9%            7.7%            5.9%          |      7.3%            3.6%            2.4%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/0             0/10 (0%)      |
|TERMINAL (d)           |     1/4 (25%)       0/6 (0%)        0/6 (0%)       |     1/30 (3%)       1/28 (4%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      646             701             667           |      465             734 (T)         569           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.384N        P=0.353N        P=0.430N       |     P=0.320N        P=0.326N        P=0.352N       |
|INCIDENTAL TUMOR       |     P=0.384N        P=0.399N        P=0.411N       |     P=0.195N        P=0.260N        P=0.174N       |
|LOGISTIC REGRESSION    |     P=0.403N        P=0.413N        P=0.446N       |     P=0.225N        P=0.408N        P=0.250N       |
|COCHRAN-ARMITAGE       |     P=0.444N                                       |     P=0.261N                                       |
|FISHER EXACT           |                     P=0.556N        P=0.507N       |                     P=0.374N        P=0.303N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/60 (3%)       3/52 (6%)       6/60 (10%)     |
|ADJUSTED (b)           |                                                    |      6.7%           10.7%           21.7%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |                                                    |     2/30 (7%)       3/28 (11%)      4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      734 (T)         734 (T)         367           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.043 *       P=0.468         P=0.074        |
|INCIDENTAL TUMOR       |                                                    |     P=0.054         P=0.468         P=0.100        |
|LOGISTIC REGRESSION    |                                                    |     P=0.045 *       P=0.468         P=0.072        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.103                                        |
|FISHER EXACT           |                                                    |                     P=0.432         P=0.136        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/60 (3%)       3/52 (6%)       7/60 (12%)     |
|ADJUSTED (b)           |                                                    |      6.7%           10.7%           23.4%          |
|INTERIM SACRIFICE 1 (c)|                                                    |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |                                                    |     2/30 (7%)       3/28 (11%)      4/23 (17%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      734 (T)         734 (T)         367           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.020 *       P=0.468         P=0.043 *      |
|INCIDENTAL TUMOR       |                                                    |     P=0.033 *       P=0.468         P=0.078        |
|LOGISTIC REGRESSION    |                                                    |     P=0.027 *       P=0.468         P=0.068        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.055                                        |
|FISHER EXACT           |                                                    |                     P=0.432         P=0.081        |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/60 (15%)     12/50 (24%)     13/60 (22%)     |    18/60 (30%)     15/52 (29%)     17/60 (28%)     |
|ADJUSTED (b)           |     65.1%           77.9%           53.1%          |     40.4%           38.1%           45.3%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     1/9 (11%)       0/2 (0%)        1/10 (10%)     |
|TERMINAL (d)           |     2/4 (50%)       4/6 (67%)       1/6 (17%)      |     6/30 (20%)      6/28 (21%)      5/23 (22%)     |
|FIRST INCIDENCE (DAYS) |      520             490             413           |      456 (I)         545             344           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.382         P=0.579         P=0.391        |     P=0.359         P=0.483N        P=0.410        |
|INCIDENTAL TUMOR       |     P=0.323         P=0.394         P=0.266        |     P=0.479N        P=0.363N        P=0.472N       |
|LOGISTIC REGRESSION    |     P=0.278         P=0.338         P=0.263        |     P=0.481N        P=0.316N        P=0.507N       |
|COCHRAN-ARMITAGE       |     P=0.275                                        |     P=0.477N                                       |
|FISHER EXACT           |                     P=0.170         P=0.240        |                     P=0.530N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       0/50 (0%)       0/60 (0%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |     14.6%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      548             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.142N        P=0.185N        P=0.187N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.190N        P=0.240N        P=0.267N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.168N        P=0.254N        P=0.229N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.172N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.295N        P=0.248N       |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  19
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       0/50 (0%)       0/60 (0%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |     14.6%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      548             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.142N        P=0.185N        P=0.187N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.190N        P=0.240N        P=0.267N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.168N        P=0.254N        P=0.229N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.172N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.295N        P=0.248N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/60 (3%)       1/50 (2%)       0/60 (0%)      |     0/60 (0%)       0/52 (0%)       0/60 (0%)      |
|ADJUSTED (b)           |      6.4%            2.0%            0.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     0/9 (0%)        0/2 (0%)        0/10 (0%)      |
|TERMINAL (d)           |     0/4 (0%)        0/6 (0%)        0/6 (0%)       |     0/30 (0%)       0/28 (0%)       0/23 (0%)      |
|FIRST INCIDENCE (DAYS) |      528             304             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.166N        P=0.493N        P=0.219N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.218N        P=0.485N        P=0.230N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.197N        P=0.686N        P=0.240N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.175N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.569N        P=0.248N       |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  20
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    51/60 (85%)     47/50 (94%)     52/60 (87%)     |    53/60 (88%)     41/52 (79%)     41/60 (68%)     |
|ADJUSTED (b)           |    100.0%          100.0%           98.0%          |     98.1%           90.9%           94.9%          |
|INTERIM SACRIFICE 1 (c)|     6/10 (60%)      0/0             5/9 (56%)      |     6/9 (67%)       0/2 (0%)        2/10 (20%)     |
|TERMINAL (d)           |     4/4 (100%)      6/6 (100%)      5/6 (83%)      |    29/30 (97%)     24/28 (86%)     21/23 (91%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         304             391           |      331             434             367           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.333N        P=0.217N        P=0.302N       |     P=0.417N        P=0.269N        P=0.381N       |
|INCIDENTAL TUMOR       |     P=0.569N        P=0.405         P=0.604N       |     P=0.023N*       P=0.057N        P=0.012N*      |
|LOGISTIC REGRESSION    |     P=0.571N        P=0.261         P=0.558        |     P=0.019N*       P=0.066N        P=0.014N*      |
|COCHRAN-ARMITAGE       |     P=0.570                                        |     P=0.006N**                                     |
|FISHER EXACT           |                     P=0.114         P=0.500        |                     P=0.135N        P=0.007N**     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/60 (28%)     21/50 (42%)     23/60 (38%)     |    33/60 (55%)     27/52 (52%)     24/60 (40%)     |
|ADJUSTED (b)           |     89.5%           85.9%           79.3%          |     70.8%           64.1%           60.5%          |
|INTERIM SACRIFICE 1 (c)|     0/10 (0%)       0/0             0/9 (0%)       |     1/9 (11%)       0/2 (0%)        1/10 (10%)     |
|TERMINAL (d)           |     3/4 (75%)       4/6 (67%)       3/6 (50%)      |    17/30 (57%)     14/28 (50%)      9/23 (39%)     |
|FIRST INCIDENCE (DAYS) |      520             304             413           |      456 (I)         494             344           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.354         P=0.529N        P=0.379        |     P=0.358N        P=0.357N        P=0.366N       |
|INCIDENTAL TUMOR       |     P=0.208         P=0.340         P=0.219        |     P=0.060N        P=0.177N        P=0.067N       |
|LOGISTIC REGRESSION    |     P=0.210         P=0.215         P=0.189        |     P=0.080N        P=0.233N        P=0.101N       |
|COCHRAN-ARMITAGE       |     P=0.210                                        |     P=0.056N                                       |
|FISHER EXACT           |                     P=0.097         P=0.166        |                     P=0.446N        P=0.072N       |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05106 TEST: 01                                                 PAGE  21
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DIETHYLPHTHALATE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0UL/RAT         100UL           300UL         |      0UL/RAT         100UL           300UL         |
|                       |      UM              RAT LM          RAT HM        |      UF              RAT LF          RAT HF        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    52/60 (87%)     49/50 (98%)     55/60 (92%)     |    58/60 (97%)     48/52 (92%)     49/60 (82%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |    100.0%          100.0%           95.9%          |
|INTERIM SACRIFICE 1 (c)|     6/10 (60%)      0/0             5/9 (56%)      |     7/9 (78%)       0/2 (0%)        3/10 (30%)     |
|TERMINAL (d)           |     4/4 (100%)      6/6 (100%)      6/6 (100%)     |    30/30 (100%)    28/28 (100%)    21/23 (91%)     |
|FIRST INCIDENCE (DAYS) |      456 (I)         304             391           |      331             434             344           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.409N        P=0.249N        P=0.376N       |     P=0.445         P=0.436N        P=0.508        |
|INCIDENTAL TUMOR       |     P=0.323         P=0.202         P=0.376        |     P=0.009N**      P=0.044N*       P=0.006N**     |
|LOGISTIC REGRESSION    |     P=0.348         P=0.082         P=0.304        |     P=0.014N*       P=0.094N        P=0.015N*      |
|COCHRAN-ARMITAGE       |     P=0.336                                        |     P=0.004N**                                     |
|FISHER EXACT           |                     P=0.031 *       P=0.279        |                     P=0.274N        P=0.008N**     |
|=================================================================================================================================|
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 456
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.