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TDMS Study 05052-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                     2,4-DICHLOROPHENOL                                  DATE: 09/07/94       
EXPERIMENT: 05052 TEST: 01                                                                                     TIME: 20:38:43       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-38068          ROUTE: DOSED FEED                                                                  NTP C#: C55345       
PATHOLOGIST: S. ESUTIS                       R. PERSING                                                        CAS: 120-83-2        
------------------------------------------------------------------------------------------------------------------------------------
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                     2,4-DICHLOROPHENOL                                  DATE: 09/07/94      
EXPERIMENT: 05052 TEST: 01                                                                                     TIME: 20:38:43      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-38068          ROUTE: DOSED FEED                                                                  NTP C#: C55345      
PATHOLOGIST: S. ESUTIS                       R. PERSING                                                        CAS: 120-83-2       
                                                    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 Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral 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: Battelle Columbus                                     2,4-DICHLOROPHENOL                                  DATE: 09/07/94       
EXPERIMENT: 05052 TEST: 01                                                                                     TIME: 20:38:43       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-38068          ROUTE: DOSED FEED                                                                  NTP C#: C55345       
PATHOLOGIST: S. ESUTIS                       R. PERSING                                                        CAS: 120-83-2        
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                       IN THE ANALYSIS OF THE STUDY OF 2,4-DICHLOROPHENOL
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Malignant Tumors
              ====================================================================================================
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Uterus                        Polyp Stromal
                                                           Sarcoma Stromal or Polyp Stromal
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
              ====================================================================================================
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   1
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    21/50 (42%)      2/3 (67%)      18/50 (36%)     |     5/50 (10%)      3/49 (6%)       3/49 (6%)      |
|ADJUSTED (b)           |     55.0%            0.0%           43.9%          |     13.8%            7.0%            7.0%          |
|TERMINAL (d)           |    16/33 (48%)      0/0            10/32 (31%)     |     4/34 (12%)      3/43 (7%)       2/39 (5%)      |
|FIRST INCIDENCE (DAYS) |      663             625             454           |      692             728 (T)         343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.353N        P=0.286N        P=0.398N       |     P=0.232N        P=0.250N        P=0.306N       |
|INCIDENTAL TUMOR       |     P=0.376N        P=0.312         P=0.430N       |     P=0.253N        P=0.315N        P=0.326N       |
|LOGISTIC REGRESSION    |     P=0.325N        P=0.235         P=0.364N       |     P=0.289N        P=0.310N        P=0.357N       |
|COCHRAN-ARMITAGE       |     P=0.305N                                       |     P=0.292N                                       |
|FISHER EXACT           |                     P=0.400         P=0.341N       |                     P=0.369N        P=0.369N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    22/50 (44%)      2/3 (67%)      18/50 (36%)     |     5/50 (10%)      3/49 (6%)       3/49 (6%)      |
|ADJUSTED (b)           |     57.6%            0.0%           43.9%          |     13.8%            7.0%            7.0%          |
|TERMINAL (d)           |    17/33 (52%)      0/0            10/32 (31%)     |     4/34 (12%)      3/43 (7%)       2/39 (5%)      |
|FIRST INCIDENCE (DAYS) |      663             625             454           |      692             728 (T)         343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.285N        P=0.286N        P=0.329N       |     P=0.232N        P=0.250N        P=0.306N       |
|INCIDENTAL TUMOR       |     P=0.304N        P=0.312         P=0.353N       |     P=0.253N        P=0.315N        P=0.326N       |
|LOGISTIC REGRESSION    |     P=0.257N        P=0.243         P=0.292N       |     P=0.289N        P=0.310N        P=0.357N       |
|COCHRAN-ARMITAGE       |     P=0.238N                                       |     P=0.292N                                       |
|FISHER EXACT           |                     P=0.428         P=0.270N       |                     P=0.369N        P=0.369N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   2
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/43 (5%)       2/3 (67%)       7/47 (15%)     |     5/38 (13%)      2/2 (100%)      3/40 (8%)      |
|ADJUSTED (b)           |      6.3%          100.0%           21.6%          |     16.1%          100.0%            8.3%          |
|TERMINAL (d)           |     2/32 (6%)       1/1 (100%)      6/31 (19%)     |     5/31 (16%)      2/2 (100%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         681             681           |      728 (T)         728 (T)         728 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.063         P=0.053         P=0.074        |     P=0.221N        P=0.029 *       P=0.275N       |
|INCIDENTAL TUMOR       |     P=0.067         P<0.001 **      P=0.073        |     P=0.221N        P=0.029 *       P=0.275N       |
|LOGISTIC REGRESSION    |     P=0.068         P=0.001 **      P=0.072        |     P=0.221N        P=0.029 *       P=0.275N       |
|COCHRAN-ARMITAGE       |     P=0.094                                        |     P=0.274N                                       |
|FISHER EXACT           |                     P=0.017 *       P=0.101        |                     P=0.027 *       P=0.327N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/43 (5%)       3/3 (100%)      7/47 (15%)     |     5/38 (13%)      2/2 (100%)      3/40 (8%)      |
|ADJUSTED (b)           |      6.3%          100.0%           21.6%          |     16.1%          100.0%            8.3%          |
|TERMINAL (d)           |     2/32 (6%)       1/1 (100%)      6/31 (19%)     |     5/31 (16%)      2/2 (100%)      3/36 (8%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         625             681           |      728 (T)         728 (T)         728 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.069         P=0.028 *       P=0.074        |     P=0.221N        P=0.029 *       P=0.275N       |
|INCIDENTAL TUMOR       |     P=0.100         P=0.002 **      P=0.073        |     P=0.221N        P=0.029 *       P=0.275N       |
|LOGISTIC REGRESSION    |     P=0.088         P<0.001 **      P=0.072        |     P=0.221N        P=0.029 *       P=0.275N       |
|COCHRAN-ARMITAGE       |     P=0.105                                        |     P=0.274N                                       |
|FISHER EXACT           |                     P<0.001 **      P=0.101        |                     P=0.027 *       P=0.327N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   3
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/8 (0%)        0/49 (0%)      |     0/50 (0%)       0/1 (0%)        0/49 (0%)      |
|ADJUSTED (b)           |      5.7%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       0/2 (0%)        0/32 (0%)      |     0/34 (0%)       0/1 (0%)        0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      680             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.125N        P=0.485N        P=0.243N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.145N        P=0.614N        P=0.263N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.138N        P=0.681N        P=0.245N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.136N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.741N        P=0.253N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/8 (0%)        0/49 (0%)      |     1/50 (2%)       0/1 (0%)        0/49 (0%)      |
|ADJUSTED (b)           |      5.7%            0.0%            0.0%          |      2.9%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       0/2 (0%)        0/32 (0%)      |     1/34 (3%)       0/1 (0%)        0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      680             ---             ---           |      728 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.125N        P=0.485N        P=0.243N       |     P=0.279N        P=0.998N        P=0.468N       |
|INCIDENTAL TUMOR       |     P=0.145N        P=0.614N        P=0.263N       |     P=0.279N        P=0.998N        P=0.468N       |
|LOGISTIC REGRESSION    |     P=0.138N        P=0.681N        P=0.245N       |     P=0.279N        P=0.998N        P=0.468N       |
|COCHRAN-ARMITAGE       |     P=0.136N                                       |     P=0.310N                                       |
|FISHER EXACT           |                     P=0.741N        P=0.253N       |                     P=0.980N        P=0.505N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   4
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       0/50 (0%)       1/50 (2%)      |     0/50 (0%)       1/23 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     12.1%            0.0%            3.1%          |      0.0%            5.0%            0.0%          |
|TERMINAL (d)           |     4/33 (12%)      0/25 (0%)       1/32 (3%)      |     0/34 (0%)       1/20 (5%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         ---             727 (T)       |      ---             728 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.094N        P=0.102N        P=0.187N       |     P=0.689N        P=0.394           (e)          |
|INCIDENTAL TUMOR       |     P=0.094N        P=0.102N        P=0.187N       |     P=0.689N        P=0.394           (e)          |
|LOGISTIC REGRESSION    |     P=0.094N        P=0.102N        P=0.187N       |     P=0.689N        P=0.393           (e)          |
|COCHRAN-ARMITAGE       |     P=0.082N                                       |     P=0.711                                        |
|FISHER EXACT           |                     P=0.059N        P=0.181N       |                     P=0.315           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/23 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.1%            4.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     3/33 (9%)       1/25 (4%)       0/32 (0%)      |     0/34 (0%)       0/20 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         727 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.071N        P=0.408N        P=0.126N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.071N        P=0.408N        P=0.126N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.071N        P=0.408N        P=0.126N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.060N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.309N        P=0.121N       |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   5
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       1/50 (2%)      |     0/50 (0%)       1/23 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.2%            4.0%            3.1%          |      0.0%            5.0%            0.0%          |
|TERMINAL (d)           |     5/33 (15%)      1/25 (4%)       1/32 (3%)      |     0/34 (0%)       1/20 (5%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         727 (T)         727 (T)       |      ---             728 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.394           (e)          |
|INCIDENTAL TUMOR       |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.394           (e)          |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.393           (e)          |
|COCHRAN-ARMITAGE       |     P=0.049N*                                      |     P=0.711                                        |
|FISHER EXACT           |                     P=0.102N        P=0.102N       |                     P=0.315           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      1/50 (2%)       1/50 (2%)      |     0/50 (0%)       1/23 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.2%            4.0%            3.1%          |      0.0%            5.0%            0.0%          |
|TERMINAL (d)           |     5/33 (15%)      1/25 (4%)       1/32 (3%)      |     0/34 (0%)       1/20 (5%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         727 (T)         727 (T)       |      ---             728 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.394           (e)          |
|INCIDENTAL TUMOR       |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.394           (e)          |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.174N        P=0.108N       |     P=0.689N        P=0.393           (e)          |
|COCHRAN-ARMITAGE       |     P=0.049N*                                      |     P=0.711                                        |
|FISHER EXACT           |                     P=0.102N        P=0.102N       |                     P=0.315           (e)          |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   6
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       3/50 (6%)       0/50 (0%)      |     9/50 (18%)      8/50 (16%)      4/50 (8%)      |
|ADJUSTED (b)           |      3.0%            9.0%            0.0%          |     20.7%           18.6%            9.5%          |
|TERMINAL (d)           |     1/33 (3%)       1/25 (4%)       0/32 (0%)      |     3/34 (9%)       8/43 (19%)      3/40 (8%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         636             ---           |      610             728 (T)         548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.397N        P=0.240         P=0.506N       |     P=0.072N        P=0.363N        P=0.108N       |
|INCIDENTAL TUMOR       |     P=0.367N        P=0.335         P=0.506N       |     P=0.174N        P=0.592         P=0.270N       |
|LOGISTIC REGRESSION    |     P=0.381N        P=0.294         P=0.506N       |     P=0.098N        P=0.503         P=0.114N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.097N                                       |
|FISHER EXACT           |                     P=0.309         P=0.500N       |                     P=0.500N        P=0.117N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       4/50 (8%)       0/50 (0%)      |     9/50 (18%)      9/50 (18%)      4/50 (8%)      |
|ADJUSTED (b)           |      6.1%           11.9%            0.0%          |     20.7%           20.9%            9.5%          |
|TERMINAL (d)           |     2/33 (6%)       1/25 (4%)       0/32 (0%)      |     3/34 (9%)       9/43 (21%)      3/40 (8%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         636             ---           |      610             728 (T)         548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.244N        P=0.254         P=0.245N       |     P=0.074N        P=0.451N        P=0.108N       |
|INCIDENTAL TUMOR       |     P=0.226N        P=0.342         P=0.245N       |     P=0.175N        P=0.496         P=0.270N       |
|LOGISTIC REGRESSION    |     P=0.228N        P=0.311         P=0.245N       |     P=0.103N        P=0.399         P=0.114N       |
|COCHRAN-ARMITAGE       |     P=0.222N                                       |     P=0.102N                                       |
|FISHER EXACT           |                     P=0.339         P=0.247N       |                     P=0.602N        P=0.117N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   7
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)     10/44 (23%)      8/49 (16%)     |    30/50 (60%)     24/32 (75%)     23/48 (48%)     |
|ADJUSTED (b)           |     16.8%           35.6%           21.6%          |     67.8%           82.5%           53.4%          |
|TERMINAL (d)           |     4/32 (13%)      6/22 (27%)      5/32 (16%)     |    20/34 (59%)     23/28 (82%)     20/40 (50%)     |
|FIRST INCIDENCE (DAYS) |      665             414             454           |      580             647             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.342         P=0.081         P=0.383        |     P=0.024N*       P=0.402N        P=0.049N*      |
|INCIDENTAL TUMOR       |     P=0.284         P=0.090         P=0.326        |     P=0.164N        P=0.195         P=0.257N       |
|LOGISTIC REGRESSION    |     P=0.341         P=0.133         P=0.386        |     P=0.123N        P=0.190         P=0.150N       |
|COCHRAN-ARMITAGE       |     P=0.343                                        |     P=0.137N                                       |
|FISHER EXACT           |                     P=0.144         P=0.387        |                     P=0.123         P=0.159N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/44 (0%)       0/49 (0%)      |     2/50 (4%)       1/32 (3%)       5/48 (10%)     |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      5.9%            2.3%           12.5%          |
|TERMINAL (d)           |     0/32 (0%)       0/22 (0%)       0/32 (0%)      |     2/34 (6%)       0/28 (0%)       5/40 (13%)     |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      728 (T)         722             728 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.189         P=0.519N        P=0.285        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.136         P=0.707N        P=0.285        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.169         P=0.600N        P=0.285        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.135                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.664N        P=0.201        |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   8
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)     10/44 (23%)      8/49 (16%)     |    32/50 (64%)     25/32 (78%)     28/48 (58%)     |
|ADJUSTED (b)           |     16.8%           35.6%           21.6%          |     72.4%           82.9%           65.0%          |
|TERMINAL (d)           |     4/32 (13%)      6/22 (27%)      5/32 (16%)     |    22/34 (65%)     23/28 (82%)     25/40 (63%)     |
|FIRST INCIDENCE (DAYS) |      665             414             454           |      580             647             548           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.342         P=0.081         P=0.383        |     P=0.065N        P=0.332N        P=0.106N       |
|INCIDENTAL TUMOR       |     P=0.284         P=0.090         P=0.326        |     P=0.369N        P=0.196         P=0.445N       |
|LOGISTIC REGRESSION    |     P=0.341         P=0.133         P=0.386        |     P=0.299N        P=0.215         P=0.342N       |
|COCHRAN-ARMITAGE       |     P=0.343                                        |     P=0.321N                                       |
|FISHER EXACT           |                     P=0.144         P=0.387        |                     P=0.133         P=0.356N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       0/25 (0%)       0/32 (0%)      |     0/34 (0%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             631           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.097           (e)           P=0.232        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.089           (e)           P=0.272        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.096           (e)           P=0.246        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.095                                        |       (e)                                          |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE   9
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       3/50 (6%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.3%            4.0%            8.2%          |      2.9%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/25 (4%)       1/32 (3%)      |     1/34 (3%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      663             727 (T)         631           |      728 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.388         P=0.579N        P=0.481        |     P=0.244N        P=0.453N        P=0.468N       |
|INCIDENTAL TUMOR       |     P=0.394         P=0.564N        P=0.507        |     P=0.244N        P=0.453N        P=0.468N       |
|LOGISTIC REGRESSION    |     P=0.394         P=0.535N        P=0.500        |     P=0.244N        P=0.453N        P=0.468N       |
|COCHRAN-ARMITAGE       |     P=0.399                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      5.3%            4.0%            3.1%          |      2.9%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       1/25 (4%)       1/32 (3%)      |     1/34 (3%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      663             727 (T)         727 (T)       |      728 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.396N        P=0.579N        P=0.516N       |     P=0.244N        P=0.453N        P=0.468N       |
|INCIDENTAL TUMOR       |     P=0.403N        P=0.564N        P=0.528N       |     P=0.244N        P=0.453N        P=0.468N       |
|LOGISTIC REGRESSION    |     P=0.389N        P=0.535N        P=0.507N       |     P=0.244N        P=0.453N        P=0.468N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  10
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            8.0%            2.1%          |      0.0%            0.0%            2.5%          |
|TERMINAL (d)           |     0/33 (0%)       2/25 (8%)       0/32 (0%)      |     0/34 (0%)       0/43 (0%)       1/40 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             727 (T)         519           |      ---             ---             728 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.360         P=0.179         P=0.500        |     P=0.286           (e)           P=0.532        |
|INCIDENTAL TUMOR       |     P=0.351         P=0.179         P=0.500        |     P=0.286           (e)           P=0.532        |
|LOGISTIC REGRESSION    |     P=0.372         P=0.179         P=0.610        |     P=0.286           (e)           P=0.532        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.269                                        |
|FISHER EXACT           |                     P=0.247         P=0.500        |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       3/50 (6%)       5/50 (10%)     |     1/50 (2%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      7.5%           12.0%           13.1%          |      2.9%            0.0%            2.5%          |
|TERMINAL (d)           |     1/33 (3%)       3/25 (12%)      2/32 (6%)      |     1/34 (3%)       0/43 (0%)       1/40 (3%)      |
|FIRST INCIDENCE (DAYS) |      656             727 (T)         519           |      728 (T)         ---             728 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.275         P=0.550         P=0.340        |     P=0.639N        P=0.453N        P=0.725N       |
|INCIDENTAL TUMOR       |     P=0.268         P=0.575         P=0.348        |     P=0.639N        P=0.453N        P=0.725N       |
|LOGISTIC REGRESSION    |     P=0.282         P=0.620         P=0.377        |     P=0.639N        P=0.453N        P=0.725N       |
|COCHRAN-ARMITAGE       |     P=0.283                                        |     P=0.669N                                       |
|FISHER EXACT           |                     P=0.661N        P=0.357        |                     P=0.500N        P=0.753N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  11
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       1/50 (2%)      |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     11.5%            4.8%            2.5%          |      0.0%            2.3%            4.0%          |
|TERMINAL (d)           |     3/33 (9%)       0/25 (0%)       0/32 (0%)      |     0/34 (0%)       1/43 (2%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      674             414             659           |      ---             728 (T)         343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.133N        P=0.417N        P=0.192N       |     P=0.151         P=0.547         P=0.240        |
|INCIDENTAL TUMOR       |     P=0.137N        P=0.334N        P=0.209N       |     P=0.280         P=0.547         P=0.401        |
|LOGISTIC REGRESSION    |     P=0.104N        P=0.287N        P=0.184N       |     P=0.157         P=0.547         P=0.252        |
|COCHRAN-ARMITAGE       |     P=0.118N                                       |     P=0.142                                        |
|FISHER EXACT           |                     P=0.339N        P=0.181N       |                     P=0.500         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      0.0%            6.6%            5.5%          |      2.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       1/25 (4%)       0/32 (0%)      |     0/34 (0%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             665             674           |      289             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.178         P=0.199         P=0.237        |     P=0.271N        P=0.504N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.145         P=0.209         P=0.195        |     P=0.183N        P=0.500N        P=0.362N       |
|LOGISTIC REGRESSION    |     P=0.175         P=0.223         P=0.239        |     P=0.215N        P=0.362N        P=0.362N       |
|COCHRAN-ARMITAGE       |     P=0.176                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.247         P=0.247        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  12
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      4/50 (8%)       3/50 (6%)      |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     13.3%           11.1%            7.9%          |      2.0%            2.3%            4.0%          |
|TERMINAL (d)           |     3/33 (9%)       1/25 (4%)       0/32 (0%)      |     0/34 (0%)       1/43 (2%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      548             414             659           |      289             728 (T)         343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.313N        P=0.596N        P=0.374N       |     P=0.391         P=0.737N        P=0.500        |
|INCIDENTAL TUMOR       |     P=0.321N        P=0.454N        P=0.377N       |     P=0.597         P=0.735N        P=0.773        |
|LOGISTIC REGRESSION    |     P=0.265N        P=0.426N        P=0.345N       |     P=0.447         P=0.765N        P=0.757        |
|COCHRAN-ARMITAGE       |     P=0.290N                                       |     P=0.378                                        |
|FISHER EXACT           |                     P=0.500N        P=0.357N       |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       2/50 (4%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.1%            6.6%            5.5%          |      2.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       1/25 (4%)       0/32 (0%)      |     0/34 (0%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      548             665             674           |      289             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.385         P=0.449         P=0.494        |     P=0.271N        P=0.504N        P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.373         P=0.575         P=0.516        |     P=0.183N        P=0.500N        P=0.362N       |
|LOGISTIC REGRESSION    |     P=0.403         P=0.551         P=0.540        |     P=0.215N        P=0.362N        P=0.362N       |
|COCHRAN-ARMITAGE       |     P=0.390                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.500         P=0.500        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  13
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.0%            0.0%            5.1%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/33 (3%)       0/25 (0%)       1/32 (3%)      |     0/34 (0%)       0/43 (0%)       0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      727 (T)         ---             454           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.359         P=0.555N        P=0.493        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.351         P=0.555N        P=0.493        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.385         P=0.555N        P=0.542        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     37/38 (97%)     46/50 (92%)     |                                                    |
|ADJUSTED (b)           |    100.0%          100.0%           97.9%          |                                                    |
|TERMINAL (d)           |    33/33 (100%)    24/24 (100%)    31/32 (97%)     |                                                    |
|FIRST INCIDENCE (DAYS) |      548             477             454           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.496N        P=0.572N        P=0.531N       |                                                    |
|INCIDENTAL TUMOR       |     P=0.406N        P=0.723         P=0.528N       |                                                    |
|LOGISTIC REGRESSION    |     P=0.331N        P=0.777N        P=0.427N       |                                                    |
|COCHRAN-ARMITAGE       |     P=0.247N                                       |                                                    |
|FISHER EXACT           |                     P=0.603         P=0.339N       |                                                    |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  14
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/49 (22%)      9/49 (18%)      6/50 (12%)     |     9/50 (18%)      0/0 (0%)        7/49 (14%)     |
|ADJUSTED (b)           |     32.2%           30.3%           17.3%          |     24.7%            0.0%           16.7%          |
|TERMINAL (d)           |    10/33 (30%)      6/24 (25%)      5/32 (16%)     |     7/34 (21%)      0/0             6/40 (15%)     |
|FIRST INCIDENCE (DAYS) |      680             469             454           |      695             ---             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.139N        P=0.529         P=0.154N       |     P=0.232N        P=0.208N        P=0.282N       |
|INCIDENTAL TUMOR       |     P=0.127N        P=0.557N        P=0.157N       |     P=0.308N          (e)           P=0.358N       |
|LOGISTIC REGRESSION    |     P=0.117N        P=0.497N        P=0.144N       |     P=0.308N          (e)           P=0.358N       |
|COCHRAN-ARMITAGE       |     P=0.108N                                       |     P=0.357N                                       |
|FISHER EXACT           |                     P=0.401N        P=0.133N       |                     P=1.000N        P=0.410N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       0/49 (0%)       0/50 (0%)      |     3/50 (6%)       0/0 (0%)        3/49 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      8.1%            0.0%            7.2%          |
|TERMINAL (d)           |     0/33 (0%)       0/24 (0%)       0/32 (0%)      |     2/34 (6%)       0/0             2/40 (5%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      692             ---             671           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.534N        P=0.495N        P=0.614N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.456           (e)           P=0.544        |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.456           (e)           P=0.544        |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.573                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=1.000N        P=0.651        |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  15
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    11/49 (22%)      9/49 (18%)      6/50 (12%)     |    12/50 (24%)      0/0 (0%)       10/49 (20%)     |
|ADJUSTED (b)           |     32.2%           30.3%           17.3%          |     31.9%            0.0%           23.4%          |
|TERMINAL (d)           |    10/33 (30%)      6/24 (25%)      5/32 (16%)     |     9/34 (26%)      0/0             8/40 (20%)     |
|FIRST INCIDENCE (DAYS) |      680             469             454           |      692             ---             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.139N        P=0.529         P=0.154N       |     P=0.236N        P=0.106N        P=0.284N       |
|INCIDENTAL TUMOR       |     P=0.127N        P=0.557N        P=0.157N       |     P=0.396N          (e)           P=0.445N       |
|LOGISTIC REGRESSION    |     P=0.117N        P=0.497N        P=0.144N       |     P=0.396N          (e)           P=0.445N       |
|COCHRAN-ARMITAGE       |     P=0.108N                                       |     P=0.379N                                       |
|FISHER EXACT           |                     P=0.401N        P=0.133N       |                     P=1.000N        P=0.426N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/49 (0%)       3/49 (6%)       0/50 (0%)      |     0/50 (0%)       0/0 (0%)        0/49 (0%)      |
|ADJUSTED (b)           |      0.0%           11.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/33 (0%)       2/24 (8%)       0/32 (0%)      |     0/34 (0%)       0/0             0/40 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             700             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.625         P=0.082           (e)          |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.622         P=0.092           (e)          |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.630         P=0.088           (e)          |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.634N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.121           (e)          |                       (e)             (e)          |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  16
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    12/50 (24%)      6/50 (12%)     11/50 (22%)     |
|ADJUSTED (b)           |                                                    |     35.3%           13.2%           24.9%          |
|TERMINAL (d)           |                                                    |    12/34 (35%)      4/43 (9%)       8/40 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      728 (T)         584             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.333N        P=0.036N*       P=0.352N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.335N        P=0.051N        P=0.304N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.445N        P=0.080N        P=0.498N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.450N                                       |
|FISHER EXACT           |                                                    |                     P=0.096N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |    13/50 (26%)      6/50 (12%)     11/50 (22%)     |
|ADJUSTED (b)           |                                                    |     36.6%           13.2%           24.9%          |
|TERMINAL (d)           |                                                    |    12/34 (35%)      4/43 (9%)       8/40 (20%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      429             584             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.252N        P=0.023N*       P=0.275N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.223N        P=0.051N        P=0.203N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.342N        P=0.063N        P=0.395N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.354N                                       |
|FISHER EXACT           |                                                    |                     P=0.062N        P=0.408N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  17
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    31/50 (62%)     17/50 (34%)     17/50 (34%)     |    11/50 (22%)      7/50 (14%)     11/50 (22%)     |
|ADJUSTED (b)           |     68.2%           46.0%           41.2%          |     26.8%           15.4%           24.3%          |
|TERMINAL (d)           |    19/33 (58%)      7/25 (28%)      9/32 (28%)     |     5/34 (15%)      5/43 (12%)      7/40 (18%)     |
|FIRST INCIDENCE (DAYS) |      419             469             454           |      636             584             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.017N*       P=0.089N        P=0.021N*      |     P=0.460N        P=0.134N        P=0.493N       |
|INCIDENTAL TUMOR       |     P=0.005N**      P=0.005N**      P=0.006N**     |     P=0.392         P=0.428N        P=0.459        |
|LOGISTIC REGRESSION    |     P=0.003N**      P=0.005N**      P=0.004N**     |     P=0.531N        P=0.378N        P=0.572N       |
|COCHRAN-ARMITAGE       |     P=0.003N**                                     |     P=0.550N                                       |
|FISHER EXACT           |                     P=0.004N**      P=0.004N**     |                     P=0.218N        P=0.595N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     43/50 (86%)     47/50 (94%)     |    43/50 (86%)     33/50 (66%)     37/50 (74%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     93.4%           71.7%           78.6%          |
|TERMINAL (d)           |    33/33 (100%)    25/25 (100%)    32/32 (100%)    |    31/34 (91%)     30/43 (70%)     30/40 (75%)     |
|FIRST INCIDENCE (DAYS) |      548             414             454           |      580             584             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.502         P=0.240         P=0.541        |     P=0.025N*       P<0.001N**      P=0.033N*      |
|INCIDENTAL TUMOR       |     P=0.566         P=0.284N        P=0.679        |     P=0.134N        P=0.008N**      P=0.137N       |
|LOGISTIC REGRESSION    |     P=0.529N        P=0.207N        P=0.648N       |     P=0.112N        P=0.006N**      P=0.116N       |
|COCHRAN-ARMITAGE       |     P=0.427N                                       |     P=0.101N                                       |
|FISHER EXACT           |                     P=0.080N        P=0.500N       |                     P=0.017N*       P=0.105N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  18
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      0 PPM           5000 PPM        10000         |      0 PPM           2500 PPM        5000 PPM      |
|                       |                                      PPM           |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    39/50 (78%)     25/50 (50%)     21/50 (42%)     |    17/50 (34%)     12/50 (24%)     20/50 (40%)     |
|ADJUSTED (b)           |     81.1%           60.5%           48.1%          |     38.3%           25.4%           43.1%          |
|TERMINAL (d)           |    24/33 (73%)     10/25 (40%)     10/32 (31%)     |     8/34 (24%)      8/43 (19%)     14/40 (35%)     |
|FIRST INCIDENCE (DAYS) |      419             426             454           |      289             562             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.006N**      P=0.160N        P=0.007N**     |     P=0.429         P=0.105N        P=0.489        |
|INCIDENTAL TUMOR       |     P<0.001N**      P=0.002N**      P<0.001N**     |     P=0.188         P=0.450N        P=0.274        |
|LOGISTIC REGRESSION    |     P<0.001N**      P=0.002N**      P<0.001N**     |     P=0.323         P=0.215N        P=0.370        |
|COCHRAN-ARMITAGE       |     P<0.001N**                                     |     P=0.297                                        |
|FISHER EXACT           |                     P=0.003N**      P<0.001N**     |                     P=0.189N        P=0.339        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    50/50 (100%)    49/50 (98%)     48/50 (96%)     |    47/50 (94%)     36/50 (72%)     44/50 (88%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     95.9%           75.0%           88.0%          |
|TERMINAL (d)           |    33/33 (100%)    25/25 (100%)    32/32 (100%)    |    32/34 (94%)     31/43 (72%)     34/40 (85%)     |
|FIRST INCIDENCE (DAYS) |      419             414             454           |      289             562             343           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.500N        P=0.096         P=0.532N       |     P=0.085N        P<0.001N**      P=0.094N       |
|INCIDENTAL TUMOR       |     P=0.349N        P=0.682N        P=0.602N       |     P=0.343N        P=0.011N*       P=0.301N       |
|LOGISTIC REGRESSION    |     P=0.228N        P=0.626N        P=0.401N       |     P=0.247N        P=0.003N**      P=0.238N       |
|COCHRAN-ARMITAGE       |     P=0.142N                                       |     P=0.244N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.247N       |                     P=0.003N**      P=0.243N       |
|=================================================================================================================================|
         DATE: 09/07/94                     EXPERIMENT: 05052 TEST: 01                                                 PAGE  19
                           STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,4-DICHLOROPHENOL
                                                 TERMINAL SACRIFICE AT 104 WEEKS
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
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