National Toxicology Program

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TDMS Study 05024-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    N-METHYLOLACRYLAMIDE                                 DATE: 09/04/94       
EXPERIMENT: 05024 TEST: 01                                                                                     TIME: 03:30:40       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 60333        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 924-42-5        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Battelle Columbus                                    N-METHYLOLACRYLAMIDE                                 DATE: 09/04/94      
EXPERIMENT: 05024 TEST: 01                                                                                     TIME: 03:30:40      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 60333       
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 924-42-5       
 
 
 
 
 
                                                    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                                    N-METHYLOLACRYLAMIDE                                 DATE: 09/04/94       
EXPERIMENT: 05024 TEST: 01                                                                                     TIME: 03:30:40       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1CP9565302          ROUTE: GAVAGE                                                                      NTP C#: 60333        
PATHOLOGIST: J. TOFT                         S. EUSTIS                                                         CAS: 924-42-5        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                      IN THE ANALYSIS OF THE STUDY OF N-METHYLOLACRYLAMIDE
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Skin                          Keratoacanthoma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Testes                        Adenoma
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Mammary Gland                 Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   1
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       1/50 (2%)      |     3/50 (6%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            9.1%            2.2%          |      8.6%            4.0%            3.0%          |
|TERMINAL (d)           |     0/28 (0%)       2/22 (9%)       0/27 (0%)      |     3/35 (9%)       0/22 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         573           |      731 (T)         711             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.358         P=0.186         P=0.500        |     P=0.229N        P=0.475N        P=0.326N       |
|INCIDENTAL TUMOR       |     P=0.340         P=0.186         P=0.464        |     P=0.227N        P=0.424N        P=0.326N       |
|LOGISTIC REGRESSION    |     P=0.361         P=0.186         P=0.510        |     P=0.227N        P=0.452N        P=0.326N       |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.202N                                       |
|FISHER EXACT           |                     P=0.247         P=0.500        |                     P=0.309N        P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/49 (37%)      7/50 (14%)     13/50 (26%)     |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     50.7%           26.2%           36.9%          |      2.9%            4.2%            5.3%          |
|TERMINAL (d)           |    10/27 (37%)      4/22 (18%)      6/27 (22%)     |     1/35 (3%)       0/22 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      637             608             654           |      731 (T)         715             625           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161N        P=0.051N        P=0.198N       |     P=0.370         P=0.657         P=0.481        |
|INCIDENTAL TUMOR       |     P=0.091N        P=0.023N*       P=0.107N       |     P=0.408         P=0.723         P=0.565        |
|LOGISTIC REGRESSION    |     P=0.115N        P=0.022N*       P=0.143N       |     P=0.376         P=0.683         P=0.500        |
|COCHRAN-ARMITAGE       |     P=0.136N                                       |     P=0.378                                        |
|FISHER EXACT           |                     P=0.008N**      P=0.175N       |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   2
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      4.7%            9.1%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/27 (0%)       2/22 (9%)       0/27 (0%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      422             731 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.181N        P=0.638         P=0.234N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.176N        P=0.691         P=0.245N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.167N        P=0.653N        P=0.212N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.171N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.684N        P=0.242N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    20/49 (41%)      9/50 (18%)     13/50 (26%)     |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     53.0%           34.4%           36.9%          |      2.9%            4.2%            5.3%          |
|TERMINAL (d)           |    10/27 (37%)      6/22 (27%)      6/27 (22%)     |     1/35 (3%)       0/22 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      422             608             654           |      731 (T)         715             625           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.088N        P=0.070N        P=0.115N       |     P=0.370         P=0.657         P=0.481        |
|INCIDENTAL TUMOR       |     P=0.040N*       P=0.029N*       P=0.049N*      |     P=0.408         P=0.723         P=0.565        |
|LOGISTIC REGRESSION    |     P=0.055N        P=0.024N*       P=0.078N       |     P=0.376         P=0.683         P=0.500        |
|COCHRAN-ARMITAGE       |     P=0.065N                                       |     P=0.378                                        |
|FISHER EXACT           |                     P=0.011N*       P=0.088N       |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   3
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       2/17 (12%)      3/48 (6%)      |     2/45 (4%)       2/17 (12%)      4/50 (8%)      |
|ADJUSTED (b)           |      5.7%            0.0%            8.9%          |      6.3%          100.0%           11.8%          |
|TERMINAL (d)           |     0/27 (0%)       0/0             1/27 (4%)      |     2/32 (6%)       1/1 (100%)      3/33 (9%)      |
|FIRST INCIDENCE (DAYS) |      688             600             548           |      731 (T)         423             726           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.429         P=0.615         P=0.517        |     P=0.295         P=0.057         P=0.347        |
|INCIDENTAL TUMOR       |     P=0.429         P=0.150         P=0.506        |     P=0.302         P=0.106         P=0.358        |
|LOGISTIC REGRESSION    |     P=0.410         P=0.070         P=0.488        |     P=0.326         P=0.221         P=0.355        |
|COCHRAN-ARMITAGE       |     P=0.406                                        |     P=0.324                                        |
|FISHER EXACT           |                     P=0.271         P=0.490        |                     P=0.300         P=0.390        |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       2/17 (12%)      3/48 (6%)      |     2/45 (4%)       2/17 (12%)      4/50 (8%)      |
|ADJUSTED (b)           |      5.7%            0.0%            8.9%          |      6.3%          100.0%           11.8%          |
|TERMINAL (d)           |     0/27 (0%)       0/0             1/27 (4%)      |     2/32 (6%)       1/1 (100%)      3/33 (9%)      |
|FIRST INCIDENCE (DAYS) |      688             600             548           |      731 (T)         423             726           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.429         P=0.615         P=0.517        |     P=0.295         P=0.057         P=0.347        |
|INCIDENTAL TUMOR       |     P=0.429         P=0.150         P=0.506        |     P=0.302         P=0.106         P=0.358        |
|LOGISTIC REGRESSION    |     P=0.410         P=0.070         P=0.488        |     P=0.326         P=0.221         P=0.355        |
|COCHRAN-ARMITAGE       |     P=0.406                                        |     P=0.324                                        |
|FISHER EXACT           |                     P=0.271         P=0.490        |                     P=0.300         P=0.390        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   4
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/14 (0%)       2/50 (4%)      |     0/50 (0%)       0/16 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            5.6%          |      0.0%            0.0%            6.1%          |
|TERMINAL (d)           |     0/28 (0%)       0/0             0/27 (0%)      |     0/35 (0%)       0/0             2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             654           |      ---             ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.109           (e)           P=0.249        |     P=0.133           (e)           P=0.225        |
|INCIDENTAL TUMOR       |     P=0.177           (e)           P=0.286        |     P=0.133           (e)           P=0.225        |
|LOGISTIC REGRESSION    |     P=0.133           (e)           P=0.238        |     P=0.133           (e)           P=0.225        |
|COCHRAN-ARMITAGE       |     P=0.127                                        |     P=0.125                                        |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)           P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       1/50 (2%)       0/50 (0%)      |     0/50 (0%)       0/21 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.3%            4.5%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/28 (14%)      1/22 (5%)       0/27 (0%)      |     0/35 (0%)       0/1 (0%)        0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.031N*       P=0.255N        P=0.066N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.031N*       P=0.255N        P=0.066N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.031N*       P=0.255N        P=0.066N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.026N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.181N        P=0.059N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   5
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/21 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.3%            8.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/28 (14%)      1/22 (5%)       0/27 (0%)      |     0/35 (0%)       0/1 (0%)        0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         722             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044N*       P=0.445N        P=0.066N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.041N*       P=0.448N        P=0.066N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.038N*       P=0.436N        P=0.066N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.339N        P=0.059N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/21 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     14.3%            8.4%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/28 (14%)      1/22 (5%)       0/27 (0%)      |     0/35 (0%)       0/1 (0%)        0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         722             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.044N*       P=0.445N        P=0.066N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.041N*       P=0.448N        P=0.066N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.038N*       P=0.436N        P=0.066N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.037N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.339N        P=0.059N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   6
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       0/17 (0%)       0/49 (0%)      |     0/50 (0%)       0/17 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      5.8%            0.0%            0.0%          |      0.0%            0.0%            3.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/0             0/27 (0%)      |     0/35 (0%)       0/0             1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      593             ---             ---           |      ---             ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.127N        P=0.524N        P=0.244N       |     P=0.298           (e)           P=0.488        |
|INCIDENTAL TUMOR       |     P=0.125N        P=0.419N        P=0.264N       |     P=0.298           (e)           P=0.488        |
|LOGISTIC REGRESSION    |     P=0.125N        P=0.555N        P=0.242N       |     P=0.298           (e)           P=0.488        |
|COCHRAN-ARMITAGE       |     P=0.126N                                       |     P=0.294                                        |
|FISHER EXACT           |                     P=0.554N        P=0.253N       |                       (e)           P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |     1/50 (2%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            6.0%          |      2.9%            3.8%            3.0%          |
|TERMINAL (d)           |     0/28 (0%)       0/22 (0%)       0/27 (0%)      |     1/35 (3%)       0/22 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             708           |      731 (T)         698             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.111           (e)           P=0.253        |     P=0.612         P=0.655         P=0.749        |
|INCIDENTAL TUMOR       |     P=0.130           (e)           P=0.286        |     P=0.622         P=0.723         P=0.749        |
|LOGISTIC REGRESSION    |     P=0.104           (e)           P=0.242        |     P=0.623         P=0.704         P=0.749        |
|COCHRAN-ARMITAGE       |     P=0.095                                        |     P=0.640                                        |
|FISHER EXACT           |                       (e)           P=0.247        |                     P=0.753N        P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   7
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |    19/50 (38%)      9/50 (18%)     17/50 (34%)     |
|ADJUSTED (b)           |      7.1%            4.5%            3.7%          |     46.7%           26.6%           48.1%          |
|TERMINAL (d)           |     2/28 (7%)       1/22 (5%)       1/27 (4%)      |    14/35 (40%)      2/22 (9%)      15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         731 (T)       |      529             443             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.393N        P=0.585N        P=0.513N       |     P=0.447N        P=0.217N        P=0.495N       |
|INCIDENTAL TUMOR       |     P=0.393N        P=0.585N        P=0.513N       |     P=0.388N        P=0.021N*       P=0.432N       |
|LOGISTIC REGRESSION    |     P=0.393N        P=0.585N        P=0.513N       |     P=0.381N        P=0.027N*       P=0.432N       |
|COCHRAN-ARMITAGE       |     P=0.378N                                       |     P=0.372N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.022N*       P=0.418N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       2/50 (4%)      |    19/50 (38%)      9/50 (18%)     17/50 (34%)     |
|ADJUSTED (b)           |      7.1%            4.5%            6.9%          |     46.7%           26.6%           48.1%          |
|TERMINAL (d)           |     2/28 (7%)       1/22 (5%)       1/27 (4%)      |    14/35 (40%)      2/22 (9%)      15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         722           |      529             443             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.598         P=0.585N        P=0.687        |     P=0.447N        P=0.217N        P=0.495N       |
|INCIDENTAL TUMOR       |     P=0.600N        P=0.585N        P=0.684N       |     P=0.388N        P=0.021N*       P=0.432N       |
|LOGISTIC REGRESSION    |     P=0.598N        P=0.585N        P=0.687N       |     P=0.381N        P=0.027N*       P=0.432N       |
|COCHRAN-ARMITAGE       |     P=0.610                                        |     P=0.372N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.691N       |                     P=0.022N*       P=0.418N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   8
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       1/50 (2%)       3/50 (6%)      |    19/50 (38%)     10/50 (20%)     17/50 (34%)     |
|ADJUSTED (b)           |      7.1%            4.5%            9.5%          |     46.7%           29.4%           48.1%          |
|TERMINAL (d)           |     2/28 (7%)       1/22 (5%)       1/27 (4%)      |    14/35 (40%)      2/22 (9%)      15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         708           |      529             443             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.402         P=0.585N        P=0.501        |     P=0.450N        P=0.303N        P=0.495N       |
|INCIDENTAL TUMOR       |     P=0.424         P=0.585N        P=0.531        |     P=0.389N        P=0.036N*       P=0.432N       |
|LOGISTIC REGRESSION    |     P=0.417         P=0.585N        P=0.516        |     P=0.382N        P=0.048N*       P=0.432N       |
|COCHRAN-ARMITAGE       |     P=0.399                                        |     P=0.372N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.038N*       P=0.418N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     14/23 (61%)     13/50 (26%)     |    19/49 (39%)     19/40 (48%)     14/50 (28%)     |
|ADJUSTED (b)           |     49.1%           63.9%           35.4%          |     43.4%           63.2%           32.1%          |
|TERMINAL (d)           |    10/28 (36%)      3/6 (50%)       6/27 (22%)     |    11/35 (31%)      7/15 (47%)      6/33 (18%)     |
|FIRST INCIDENCE (DAYS) |      410             421             425           |      529             458             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.161N        P=0.224         P=0.172N       |     P=0.273N        P=0.045 *       P=0.275N       |
|INCIDENTAL TUMOR       |     P=0.120N        P=0.099         P=0.139N       |     P=0.101N        P=0.342         P=0.107N       |
|LOGISTIC REGRESSION    |     P=0.128N        P=0.084         P=0.143N       |     P=0.094N        P=0.362         P=0.083N       |
|COCHRAN-ARMITAGE       |     P=0.128N                                       |     P=0.156N                                       |
|FISHER EXACT           |                     P=0.058         P=0.142N       |                     P=0.270         P=0.178N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE   9
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    19/50 (38%)     14/23 (61%)     14/50 (28%)     |    19/49 (39%)     19/40 (48%)     14/50 (28%)     |
|ADJUSTED (b)           |     49.1%           63.9%           37.1%          |     43.4%           63.2%           32.1%          |
|TERMINAL (d)           |    10/28 (36%)      3/6 (50%)       6/27 (22%)     |    11/35 (31%)      7/15 (47%)      6/33 (18%)     |
|FIRST INCIDENCE (DAYS) |      410             421             425           |      529             458             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.210N        P=0.224         P=0.226N       |     P=0.273N        P=0.045 *       P=0.275N       |
|INCIDENTAL TUMOR       |     P=0.162N        P=0.099         P=0.187N       |     P=0.101N        P=0.342         P=0.107N       |
|LOGISTIC REGRESSION    |     P=0.178N        P=0.084         P=0.199N       |     P=0.094N        P=0.362         P=0.083N       |
|COCHRAN-ARMITAGE       |     P=0.177N                                       |     P=0.156N                                       |
|FISHER EXACT           |                     P=0.058         P=0.198N       |                     P=0.270         P=0.178N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       6/50 (12%)      3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.6%           23.1%            8.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       3/22 (14%)      0/27 (0%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         608             695           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.291         P=0.033 *       P=0.323        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.319         P=0.043 *       P=0.362        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.287         P=0.035 *       P=0.311        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.274                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.056         P=0.309        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  10
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.6%            9.1%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       2/22 (9%)       0/27 (0%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         731 (T)         ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.375N        P=0.415         P=0.507N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.375N        P=0.415         P=0.507N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.375N        P=0.415         P=0.507N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.360N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       8/50 (16%)      4/50 (8%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |     10.7%           31.2%           11.8%          |      2.9%            0.0%            0.0%          |
|TERMINAL (d)           |     3/28 (11%)      5/22 (23%)      1/27 (4%)      |     1/35 (3%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         608             695           |      731 (T)         ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.435         P=0.047 *       P=0.504        |     P=0.291N        P=0.593N        P=0.512N       |
|INCIDENTAL TUMOR       |     P=0.467         P=0.058         P=0.541        |     P=0.291N        P=0.593N        P=0.512N       |
|LOGISTIC REGRESSION    |     P=0.454         P=0.051         P=0.517        |     P=0.291N        P=0.593N        P=0.512N       |
|COCHRAN-ARMITAGE       |     P=0.434                                        |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.100         P=0.500        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  11
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       2/50 (4%)      |     0/50 (0%)       1/50 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.3%            5.5%            5.8%          |      0.0%            3.0%            0.0%          |
|TERMINAL (d)           |     0/28 (0%)       0/22 (0%)       1/27 (4%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      624             549             573           |      ---             644             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.403N        P=0.570N        P=0.496N       |     P=0.715         P=0.443           (e)          |
|INCIDENTAL TUMOR       |     P=0.406N        P=0.368N        P=0.534N       |     P=0.686N        P=0.718           (e)          |
|LOGISTIC REGRESSION    |     P=0.466N        P=0.420N        P=0.501N       |     P=0.736N        P=0.524           (e)          |
|COCHRAN-ARMITAGE       |     P=0.406N                                       |     P=0.731                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       2/50 (4%)       2/50 (4%)      |     1/50 (2%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |      7.3%            5.5%            5.8%          |      2.0%            5.9%            0.0%          |
|TERMINAL (d)           |     0/28 (0%)       0/22 (0%)       1/27 (4%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      624             549             573           |      351             641             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.403N        P=0.570N        P=0.496N       |     P=0.374N        P=0.433         P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.406N        P=0.368N        P=0.534N       |     P=0.318N        P=0.672N          (e)          |
|LOGISTIC REGRESSION    |     P=0.466N        P=0.420N        P=0.501N       |     P=0.347N        P=0.675           (e)          |
|COCHRAN-ARMITAGE       |     P=0.406N                                       |     P=0.360N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  12
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    40/50 (80%)     41/48 (85%)     46/50 (92%)     |                                                    |
|ADJUSTED (b)           |     90.9%          100.0%          100.0%          |                                                    |
|TERMINAL (d)           |    24/28 (86%)     22/22 (100%)    27/27 (100%)    |                                                    |
|FIRST INCIDENCE (DAYS) |      593             492             487           |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.186         P=0.087         P=0.201        |                                                    |
|INCIDENTAL TUMOR       |     P=0.040 *       P=0.057         P=0.079        |                                                    |
|LOGISTIC REGRESSION    |     P=0.021 *       P=0.041 *       P=0.044 *      |                                                    |
|COCHRAN-ARMITAGE       |     P=0.057                                        |                                                    |
|FISHER EXACT           |                     P=0.330         P=0.074        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     7/50 (14%)      4/17 (24%)      9/50 (18%)     |    11/50 (22%)      2/17 (12%)      7/50 (14%)     |
|ADJUSTED (b)           |     19.5%          100.0%           24.4%          |     30.2%          100.0%           19.4%          |
|TERMINAL (d)           |     3/28 (11%)      3/3 (100%)      4/27 (15%)     |    10/35 (29%)      1/1 (100%)      5/33 (15%)     |
|FIRST INCIDENCE (DAYS) |      593             608             425           |      639             575             625           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.344         P=0.309         P=0.402        |     P=0.221N        P=0.356         P=0.258N       |
|INCIDENTAL TUMOR       |     P=0.334         P=0.146         P=0.369        |     P=0.174N        P=0.606         P=0.198N       |
|LOGISTIC REGRESSION    |     P=0.345         P=0.074         P=0.388        |     P=0.203N        P=0.262         P=0.236N       |
|COCHRAN-ARMITAGE       |     P=0.345                                        |     P=0.176N                                       |
|FISHER EXACT           |                     P=0.286         P=0.393        |                     P=0.296N        P=0.218N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  13
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      4/17 (24%)     10/50 (20%)     |    12/50 (24%)      2/17 (12%)      7/50 (14%)     |
|ADJUSTED (b)           |     22.7%          100.0%           27.7%          |     33.0%          100.0%           19.4%          |
|TERMINAL (d)           |     4/28 (14%)      3/3 (100%)      5/27 (19%)     |    11/35 (31%)      1/1 (100%)      5/33 (15%)     |
|FIRST INCIDENCE (DAYS) |      593             608             425           |      639             575             625           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.346         P=0.338         P=0.402        |     P=0.158N        P=0.369         P=0.188N       |
|INCIDENTAL TUMOR       |     P=0.337         P=0.172         P=0.371        |     P=0.120N        P=0.619         P=0.139N       |
|LOGISTIC REGRESSION    |     P=0.352         P=0.090         P=0.393        |     P=0.144N        P=0.271         P=0.170N       |
|COCHRAN-ARMITAGE       |     P=0.351                                        |     P=0.120N                                       |
|FISHER EXACT           |                     P=0.357         P=0.398        |                     P=0.240N        P=0.154N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/17 (0%)       0/50 (0%)      |     2/50 (4%)       0/17 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      5.0%            0.0%            5.3%          |
|TERMINAL (d)           |     0/28 (0%)       0/3 (0%)        0/27 (0%)      |     1/35 (3%)       0/1 (0%)        1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      639             ---             652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.586         P=0.532N        P=0.671        |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.579N        P=0.320N        P=0.644N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.603         P=0.671N        P=0.694N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.608                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.554N        P=0.691N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  14
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/17 (6%)       0/50 (0%)      |     2/50 (4%)       0/17 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |      0.0%            3.6%            0.0%          |      5.0%            0.0%            5.3%          |
|TERMINAL (d)           |     0/28 (0%)       0/3 (0%)        0/27 (0%)      |     1/35 (3%)       0/1 (0%)        1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             695             ---           |      639             ---             652           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.706N        P=0.461           (e)          |     P=0.586         P=0.532N        P=0.671        |
|INCIDENTAL TUMOR       |     P=0.656N        P=0.056           (e)          |     P=0.579N        P=0.320N        P=0.644N       |
|LOGISTIC REGRESSION    |     P=0.701N        P=0.160           (e)          |     P=0.603         P=0.671N        P=0.694N       |
|COCHRAN-ARMITAGE       |     P=0.706                                        |     P=0.608                                        |
|FISHER EXACT           |                     P=0.254           (e)          |                     P=0.554N        P=0.691N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     8/50 (16%)      2/50 (4%)       9/50 (18%)     |
|ADJUSTED (b)           |                                                    |     20.3%            6.6%           25.7%          |
|TERMINAL (d)           |                                                    |     5/35 (14%)      0/22 (0%)       7/33 (21%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      656             575             715           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.404         P=0.166N        P=0.449        |
|INCIDENTAL TUMOR       |                                                    |     P=0.430         P=0.058N        P=0.462        |
|LOGISTIC REGRESSION    |                                                    |     P=0.419         P=0.074N        P=0.466        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.440                                        |
|FISHER EXACT           |                                                    |                     P=0.046N*       P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  15
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       3/50 (6%)       0/50 (0%)      |
|ADJUSTED (b)           |                                                    |      0.0%            8.9%            0.0%          |
|TERMINAL (d)           |                                                    |     0/35 (0%)       1/22 (5%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             458             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.630         P=0.088           (e)          |
|INCIDENTAL TUMOR       |                                                    |     P=0.656         P=0.224           (e)          |
|LOGISTIC REGRESSION    |                                                    |     P=0.651         P=0.179           (e)          |
|COCHRAN-ARMITAGE       |                                                    |     P=0.640                                        |
|FISHER EXACT           |                                                    |                     P=0.121           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     8/50 (16%)      5/50 (10%)      9/50 (18%)     |
|ADJUSTED (b)           |                                                    |     20.3%           14.9%           25.7%          |
|TERMINAL (d)           |                                                    |     5/35 (14%)      1/22 (5%)       7/33 (21%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      656             458             715           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.409         P=0.543N        P=0.449        |
|INCIDENTAL TUMOR       |                                                    |     P=0.431         P=0.224N        P=0.462        |
|LOGISTIC REGRESSION    |                                                    |     P=0.437         P=0.272N        P=0.466        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.444                                        |
|FISHER EXACT           |                                                    |                     P=0.277N        P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  16
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    18/50 (36%)     18/50 (36%)     24/50 (48%)     |    14/50 (28%)     11/50 (22%)     15/50 (30%)     |
|ADJUSTED (b)           |     46.1%           49.2%           60.3%          |     35.2%           31.1%           37.6%          |
|TERMINAL (d)           |     8/28 (29%)      6/22 (27%)     12/27 (44%)     |    10/35 (29%)      1/22 (5%)       9/33 (27%)     |
|FIRST INCIDENCE (DAYS) |      554             509             548           |      676             508             595           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.185         P=0.333         P=0.200        |     P=0.406         P=0.428         P=0.437        |
|INCIDENTAL TUMOR       |     P=0.160         P=0.564         P=0.193        |     P=0.490         P=0.267N        P=0.480        |
|LOGISTIC REGRESSION    |     P=0.108         P=0.576         P=0.159        |     P=0.445         P=0.411N        P=0.477        |
|COCHRAN-ARMITAGE       |     P=0.131                                        |     P=0.455                                        |
|FISHER EXACT           |                     P=0.582N        P=0.156        |                     P=0.322N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.5%            2.1%            7.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/28 (0%)       0/22 (0%)       2/27 (7%)      |     0/35 (0%)       0/22 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      655             492             731 (T)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.375         P=0.733         P=0.492        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.375         P=0.723N        P=0.517        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.375         P=0.695N        P=0.504        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.378                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.753N        P=0.500        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  17
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    48/50 (96%)     48/50 (96%)     49/50 (98%)     |    39/50 (78%)     28/50 (56%)     36/50 (72%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     82.9%           67.8%           79.7%          |
|TERMINAL (d)           |    28/28 (100%)    22/22 (100%)    27/27 (100%)    |    27/35 (77%)     10/22 (45%)     24/33 (73%)     |
|FIRST INCIDENCE (DAYS) |      410             421             425           |      529             423             443           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.461         P=0.105         P=0.485        |     P=0.462N        P=0.463         P=0.500N       |
|INCIDENTAL TUMOR       |     P=0.457         P=0.477         P=0.620        |     P=0.258N        P=0.009N**      P=0.255N       |
|LOGISTIC REGRESSION    |     P=0.244         P=0.443         P=0.425        |     P=0.300N        P=0.008N**      P=0.333N       |
|COCHRAN-ARMITAGE       |     P=0.390                                        |     P=0.295N                                       |
|FISHER EXACT           |                     P=0.691N        P=0.500        |                     P=0.016N*       P=0.322N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    23/50 (46%)     23/50 (46%)     29/50 (58%)     |    18/50 (36%)     16/50 (32%)     18/50 (36%)     |
|ADJUSTED (b)           |     54.8%           57.2%           69.7%          |     43.2%           42.0%           44.0%          |
|TERMINAL (d)           |    10/28 (36%)      7/22 (32%)     15/27 (56%)     |    12/35 (34%)      3/22 (14%)     11/33 (33%)     |
|FIRST INCIDENCE (DAYS) |      422             379             487           |      351             458             383           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.206         P=0.313         P=0.218        |     P=0.476         P=0.279         P=0.507        |
|INCIDENTAL TUMOR       |     P=0.156         P=0.533N        P=0.188        |     P=0.535N        P=0.282N        P=0.471        |
|LOGISTIC REGRESSION    |     P=0.135         P=0.517N        P=0.159        |     P=0.541N        P=0.402N        P=0.582N       |
|COCHRAN-ARMITAGE       |     P=0.136                                        |     P=0.542N                                       |
|FISHER EXACT           |                     P=0.579N        P=0.158        |                     P=0.417N        P=0.582N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 01                                                 PAGE  18
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         6 MG/KG         12 MG/KG      |      VEHICLE         6 MG/KG         12 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    49/50 (98%)     49/50 (98%)     49/50 (98%)     |    45/50 (90%)     36/50 (72%)     42/50 (84%)     |
|ADJUSTED (b)           |    100.0%          100.0%          100.0%          |     91.8%           77.6%           87.4%          |
|TERMINAL (d)           |    28/28 (100%)    22/22 (100%)    27/27 (100%)    |    31/35 (89%)     12/22 (55%)     27/33 (82%)     |
|FIRST INCIDENCE (DAYS) |      410             379             425           |      351             423             383           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.519         P=0.110         P=0.546        |     P=0.480N        P=0.235         P=0.515N       |
|INCIDENTAL TUMOR       |     P=0.601N        P=0.638         P=0.712N       |     P=0.195N        P=0.005N**      P=0.282N       |
|LOGISTIC REGRESSION    |     P=0.604         P=0.633         P=0.749        |     P=0.198N        P=0.003N**      P=0.278N       |
|COCHRAN-ARMITAGE       |     P=0.640                                        |     P=0.258N                                       |
|FISHER EXACT           |                     P=0.753N        P=0.753N       |                     P=0.020N*       P=0.277N       |
|=================================================================================================================================|
 
 (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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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.