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TDMS Study 05704-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                                      RESORCINOL                                      DATE: 09/18/94       
EXPERIMENT: 05704 TEST: 02                                                                                     TIME: 18:06:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: 05700-04              ROUTE: GAVAGE                                                                      NTP C#: 05970A       
PATHOLOGIST: F. VOELKER                      S. EUSTIS                                                         CAS: 108-46-3        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: IRDC                                                      RESORCINOL                                      DATE: 09/18/94      
EXPERIMENT: 05704 TEST: 02                                                                                     TIME: 18:06:20      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: 05700-04              ROUTE: GAVAGE                                                                      NTP C#: 05970A      
PATHOLOGIST: F. VOELKER                      S. EUSTIS                                                         CAS: 108-46-3       
 
 
 
 
 
                                                    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
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: IRDC                                                      RESORCINOL                                      DATE: 09/18/94       
EXPERIMENT: 05704 TEST: 02                                                                                     TIME: 18:06:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: 05700-04              ROUTE: GAVAGE                                                                      NTP C#: 05970A       
PATHOLOGIST: F. VOELKER                      S. EUSTIS                                                         CAS: 108-46-3        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                           IN THE ANALYSIS OF THE STUDY OF RESORCINOL
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Malignant
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             Testes                        Adenoma
                             Thyroid Gland: C-Cell         Adenoma
 
              ====================================================================================================
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   1
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     9/49 (18%)      9/50 (18%)      5/49 (10%)       |
|ADJUSTED (b)           |     27.3%           32.9%           39.2%            |
|TERMINAL (d)           |     5/27 (19%)      7/25 (28%)      2/9 (22%)        |
|FIRST INCIDENCE (DAYS) |      558             666             576             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.272         P=0.525         P=0.323          |
|INCIDENTAL TUMOR       |     P=0.415         P=0.579         P=0.545          |
|LOGISTIC REGRESSION    |     P=0.425         P=0.592         P=0.525          |
|COCHRAN-ARMITAGE       |     P=0.164N                                         |
|FISHER EXACT           |                     P=0.584N        P=0.194N         |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Malignant                                               |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     5/49 (10%)      2/50 (4%)       0/49 (0%)        |
|ADJUSTED (b)           |     16.2%            6.8%            0.0%            |
|TERMINAL (d)           |     3/27 (11%)      1/25 (4%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      644             650             ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.089N        P=0.255N        P=0.200N         |
|INCIDENTAL TUMOR       |     P=0.060N        P=0.224N        P=0.135N         |
|LOGISTIC REGRESSION    |     P=0.053N        P=0.216N        P=0.136N         |
|COCHRAN-ARMITAGE       |     P=0.016N*                                        |
|FISHER EXACT           |                     P=0.210N        P=0.028N*        |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   2
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    14/49 (29%)     11/50 (22%)      5/49 (10%)       |
|ADJUSTED (b)           |     40.8%           38.5%           39.2%            |
|TERMINAL (d)           |     8/27 (30%)      8/25 (32%)      2/9 (22%)        |
|FIRST INCIDENCE (DAYS) |      558             650             576             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.493N        P=0.415N        P=0.591N         |
|INCIDENTAL TUMOR       |     P=0.301N        P=0.343N        P=0.325N         |
|LOGISTIC REGRESSION    |     P=0.284N        P=0.327N        P=0.347N         |
|COCHRAN-ARMITAGE       |     P=0.016N*                                        |
|FISHER EXACT           |                     P=0.301N        P=0.020N*        |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     8/50 (16%)      6/49 (12%)      2/50 (4%)        |
|ADJUSTED (b)           |     26.6%           19.3%           15.2%            |
|TERMINAL (d)           |     7/28 (25%)      3/25 (12%)      1/9 (11%)        |
|FIRST INCIDENCE (DAYS) |      499             492             560             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.349N        P=0.459N        P=0.456N         |
|INCIDENTAL TUMOR       |     P=0.153N        P=0.387N        P=0.282N         |
|LOGISTIC REGRESSION    |     P=0.166N        P=0.409N        P=0.263N         |
|COCHRAN-ARMITAGE       |     P=0.038N*                                        |
|FISHER EXACT           |                     P=0.403N        P=0.046N*        |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   3
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Clitoral/Preputial Gland                                                      |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     9/50 (18%)      7/49 (14%)      3/50 (6%)        |
|ADJUSTED (b)           |     28.9%           21.6%           25.8%            |
|TERMINAL (d)           |     7/28 (25%)      3/25 (12%)      2/9 (22%)        |
|FIRST INCIDENCE (DAYS) |      499             492             560             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.472N        P=0.471N        P=0.593N         |
|INCIDENTAL TUMOR       |     P=0.218N        P=0.388N        P=0.406N         |
|LOGISTIC REGRESSION    |     P=0.238N        P=0.415N        P=0.379N         |
|COCHRAN-ARMITAGE       |     P=0.050N*                                        |
|FISHER EXACT           |                     P=0.410N        P=0.061N         |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     2/49 (4%)       2/49 (4%)       0/50 (0%)        |
|ADJUSTED (b)           |      7.1%            6.3%            0.0%            |
|TERMINAL (d)           |     2/28 (7%)       1/24 (4%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      729 (T)         562             ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.402N        P=0.652         P=0.509N         |
|INCIDENTAL TUMOR       |     P=0.337N        P=0.685         P=0.509N         |
|LOGISTIC REGRESSION    |     P=0.300N        P=0.689         P=0.509N         |
|COCHRAN-ARMITAGE       |     P=0.172N                                         |
|FISHER EXACT           |                     P=0.691N        P=0.242N         |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   4
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     2/50 (4%)       0/50 (0%)       0/50 (0%)        |
|ADJUSTED (b)           |      5.7%            0.0%            0.0%            |
|TERMINAL (d)           |     1/28 (4%)       0/25 (0%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      558             ---             ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.171N        P=0.255N        P=0.455N         |
|INCIDENTAL TUMOR       |     P=0.131N        P=0.227N        P=0.356N         |
|LOGISTIC REGRESSION    |     P=0.101N        P=0.238N        P=0.314N         |
|COCHRAN-ARMITAGE       |     P=0.096N                                         |
|FISHER EXACT           |                     P=0.247N        P=0.247N         |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroadenoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       0/50 (0%)        |
|ADJUSTED (b)           |      6.3%            4.0%            0.0%            |
|TERMINAL (d)           |     1/28 (4%)       1/25 (4%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      657             729 (T)         ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.313N        P=0.540N        P=0.494N         |
|INCIDENTAL TUMOR       |     P=0.285N        P=0.526N        P=0.438N         |
|LOGISTIC REGRESSION    |     P=0.257N        P=0.512N        P=0.403N         |
|COCHRAN-ARMITAGE       |     P=0.142N                                         |
|FISHER EXACT           |                     P=0.500N        P=0.247N         |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   5
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Mammary Gland                                                                 |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/50 (0%)        |
|ADJUSTED (b)           |      9.7%            4.0%            0.0%            |
|TERMINAL (d)           |     2/28 (7%)       1/25 (4%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      657             729 (T)         ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.179N        P=0.348N        P=0.367N         |
|INCIDENTAL TUMOR       |     P=0.163N        P=0.337N        P=0.327N         |
|LOGISTIC REGRESSION    |     P=0.142N        P=0.321N        P=0.289N         |
|COCHRAN-ARMITAGE       |     P=0.061N                                         |
|FISHER EXACT           |                     P=0.309N        P=0.121N         |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    14/50 (28%)      9/50 (18%)      3/49 (6%)        |
|ADJUSTED (b)           |     40.1%           24.9%           28.7%            |
|TERMINAL (d)           |     8/28 (29%)      3/25 (12%)      2/9 (22%)        |
|FIRST INCIDENCE (DAYS) |      569             532             721             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.176N        P=0.250N        P=0.289N         |
|INCIDENTAL TUMOR       |     P=0.041N*       P=0.154N        P=0.145N         |
|LOGISTIC REGRESSION    |     P=0.041N*       P=0.173N        P=0.132N         |
|COCHRAN-ARMITAGE       |     P=0.003N**                                       |
|FISHER EXACT           |                     P=0.171N        P=0.004N**       |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   6
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Keratoacanthoma                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       1/50 (2%)        |
|ADJUSTED (b)           |      2.8%            7.7%           11.1%            |
|TERMINAL (d)           |     0/28 (0%)       1/25 (4%)       1/9 (11%)        |
|FIRST INCIDENCE (DAYS) |      657             719             729 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.323         P=0.457         P=0.506          |
|INCIDENTAL TUMOR       |     P=0.376         P=0.487         P=0.562          |
|LOGISTIC REGRESSION    |     P=0.381         P=0.490         P=0.597          |
|COCHRAN-ARMITAGE       |     P=0.622N                                         |
|FISHER EXACT           |                     P=0.500         P=0.753N         |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)        |
|ADJUSTED (b)           |      0.0%            6.0%            0.0%            |
|TERMINAL (d)           |     0/28 (0%)       1/25 (4%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      ---             492             ---             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.517         P=0.232           (e)            |
|INCIDENTAL TUMOR       |     P=0.644N        P=0.281           (e)            |
|LOGISTIC REGRESSION    |     P=0.677         P=0.234           (e)            |
|COCHRAN-ARMITAGE       |     P=0.667N                                         |
|FISHER EXACT           |                     P=0.247           (e)            |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   7
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     1/50 (2%)       5/50 (10%)      1/50 (2%)        |
|ADJUSTED (b)           |      2.8%           16.6%           11.1%            |
|TERMINAL (d)           |     0/28 (0%)       2/25 (8%)       1/9 (11%)        |
|FIRST INCIDENCE (DAYS) |      657             492             729 (T)         |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.236         P=0.090         P=0.506          |
|INCIDENTAL TUMOR       |     P=0.394         P=0.112         P=0.562          |
|LOGISTIC REGRESSION    |     P=0.354         P=0.103         P=0.597          |
|COCHRAN-ARMITAGE       |     P=0.592N                                         |
|FISHER EXACT           |                     P=0.102         P=0.753N         |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Fibroma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       1/50 (2%)        |
|ADJUSTED (b)           |      9.1%            2.9%            8.3%            |
|TERMINAL (d)           |     2/28 (7%)       0/25 (0%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      478             650             721             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.457N        P=0.334N        P=0.658N         |
|INCIDENTAL TUMOR       |     P=0.279N        P=0.282N        P=0.441N         |
|LOGISTIC REGRESSION    |     P=0.300N        P=0.305N        P=0.506N         |
|COCHRAN-ARMITAGE       |     P=0.202N                                         |
|FISHER EXACT           |                     P=0.309N        P=0.309N         |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   8
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Skin: Subcutaneous Tissue                                                     |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                |
|     Neurofibroma, or Fibroma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       1/50 (2%)        |
|ADJUSTED (b)           |     12.6%            5.5%            8.3%            |
|TERMINAL (d)           |     3/28 (11%)      0/25 (0%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      478             624             721             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.376N        P=0.375N        P=0.549N         |
|INCIDENTAL TUMOR       |     P=0.197N        P=0.310N        P=0.349N         |
|LOGISTIC REGRESSION    |     P=0.211N        P=0.336N        P=0.395N         |
|COCHRAN-ARMITAGE       |     P=0.118N                                         |
|FISHER EXACT           |                     P=0.339N        P=0.181N         |
|==============================================================================|
|                                                                              |
|Testes                                                                        |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |    45/50 (90%)     44/50 (88%)     31/50 (62%)       |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%            |
|TERMINAL (d)           |    28/28 (100%)    25/25 (100%)     9/9 (100%)       |
|FIRST INCIDENCE (DAYS) |      478             380             400             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P<0.001 **      P=0.363         P<0.001 **       |
|INCIDENTAL TUMOR       |     P=0.159         P=0.528N        P=0.182          |
|LOGISTIC REGRESSION    |     P=0.134         P=0.446N        P=0.159          |
|COCHRAN-ARMITAGE       |     P<0.001N**                                       |
|FISHER EXACT           |                     P=0.500N        P<0.001N**       |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE   9
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|Thyroid Gland: C-Cell                                                         |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |     3/49 (6%)       4/49 (8%)       5/49 (10%)       |
|ADJUSTED (b)           |      8.8%           14.9%           38.9%            |
|TERMINAL (d)           |     1/28 (4%)       3/25 (12%)      3/9 (33%)        |
|FIRST INCIDENCE (DAYS) |      499             692             412             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.028 *       P=0.446         P=0.041 *        |
|INCIDENTAL TUMOR       |     P=0.101         P=0.504         P=0.189          |
|LOGISTIC REGRESSION    |     P=0.099         P=0.498         P=0.158          |
|COCHRAN-ARMITAGE       |     P=0.290                                          |
|FISHER EXACT           |                     P=0.500         P=0.357          |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                           |
|     or Undifferentiated                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    17/50 (34%)     25/50 (50%)      8/50 (16%)       |
|ADJUSTED (b)           |     48.5%           61.5%           49.4%            |
|TERMINAL (d)           |    11/28 (39%)     10/25 (40%)      3/9 (33%)        |
|FIRST INCIDENCE (DAYS) |      569             492             503             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.183         P=0.066         P=0.347          |
|INCIDENTAL TUMOR       |     P=0.442N        P=0.076         P=0.445N         |
|LOGISTIC REGRESSION    |     P=0.491N        P=0.072         P=0.443N         |
|COCHRAN-ARMITAGE       |     P=0.035N*                                        |
|FISHER EXACT           |                     P=0.078         P=0.032N*        |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE  10
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Mesothelioma Benign, Malignant, NOS                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       1/50 (2%)        |
|ADJUSTED (b)           |     10.9%            8.0%            7.7%            |
|TERMINAL (d)           |     1/28 (4%)       2/25 (8%)       0/9 (0%)         |
|FIRST INCIDENCE (DAYS) |      478             729 (T)         706             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.375N        P=0.382N        P=0.523N         |
|INCIDENTAL TUMOR       |     P=0.218N        P=0.325N        P=0.267N         |
|LOGISTIC REGRESSION    |     P=0.220N        P=0.337N        P=0.305N         |
|COCHRAN-ARMITAGE       |     P=0.118N                                         |
|FISHER EXACT           |                     P=0.339N        P=0.181N         |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    46/50 (92%)     48/50 (96%)     31/50 (62%)       |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%            |
|TERMINAL (d)           |    28/28 (100%)    25/25 (100%)     9/9 (100%)       |
|FIRST INCIDENCE (DAYS) |      478             380             400             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.001 **      P=0.212         P=0.001 **       |
|INCIDENTAL TUMOR       |     P=0.321         P=0.389         P=0.332          |
|LOGISTIC REGRESSION    |     P=0.304         P=0.420         P=0.325          |
|COCHRAN-ARMITAGE       |     P<0.001N**                                       |
|FISHER EXACT           |                     P=0.339         P<0.001N**       |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE  11
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 WEEKS
 
|==============================================================================|
|DOSE                   |      CONTROL         112MG/KG        225MG/KG        |
|                       |      MALE            MALE            MALE            |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    28/50 (56%)     32/50 (64%)     13/50 (26%)       |
|ADJUSTED (b)           |     66.1%           75.7%           68.5%            |
|TERMINAL (d)           |    14/28 (50%)     15/25 (60%)      4/9 (44%)        |
|FIRST INCIDENCE (DAYS) |      384             492             492             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.210         P=0.198         P=0.324          |
|INCIDENTAL TUMOR       |     P=0.160N        P=0.302         P=0.131N         |
|LOGISTIC REGRESSION    |     P=0.216N        P=0.262         P=0.208N         |
|COCHRAN-ARMITAGE       |     P=0.002N**                                       |
|FISHER EXACT           |                     P=0.270         P=0.002N**       |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #              |
|-----------            |                                                      |
|OVERALL (a)            |    47/50 (94%)     49/50 (98%)     31/50 (62%)       |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%            |
|TERMINAL (d)           |    28/28 (100%)    25/25 (100%)     9/9 (100%)       |
|FIRST INCIDENCE (DAYS) |      384             380             400             |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |     P=0.002 **      P=0.217         P=0.002 **       |
|INCIDENTAL TUMOR       |     P=0.604N        P=0.455         P=0.716          |
|LOGISTIC REGRESSION    |     P=0.534N        P=0.400         P=0.718          |
|COCHRAN-ARMITAGE       |     P<0.001N**                                       |
|FISHER EXACT           |                     P=0.309         P<0.001N**       |
|==============================================================================|
 
         DATE: 09/18/94                     EXPERIMENT: 05704 TEST: 02                                                 PAGE  12
    STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- RESORCINOL
 
                       TERMINAL SACRIFICE AT 105 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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