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TDMS Study 05024-02 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    N-METHYLOLACRYLAMIDE                                 DATE: 09/04/94       
EXPERIMENT: 05024 TEST: 02                                                                                     TIME: 04:50:13       
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: 02                                                                                     TIME: 04:50:13      
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       
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             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
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Larynx
                                                    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: 02                                                                                     TIME: 04:50:13       
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 MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Harderian Gland               Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                             Harderian Gland               Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Ovary                         Granulosa Cell Tumor Benign
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Adenoma
                             All Organs                    Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       1/20 (5%)       3/50 (6%)      |     0/50 (0%)       1/7 (14%)       0/48 (0%)      |
|ADJUSTED (b)           |      6.4%            0.0%           14.3%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/0             3/21 (14%)     |     0/41 (0%)       0/0             0/32 (0%)      |
|FIRST INCIDENCE (DAYS) |      683             684             731 (T)       |      ---             718             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.291         P=0.724         P=0.372        |     P=0.706         P=0.469           (e)          |
|INCIDENTAL TUMOR       |     P=0.402         P=0.282         P=0.443        |     P=0.620N        P=0.128           (e)          |
|LOGISTIC REGRESSION    |     P=0.345         P=0.311         P=0.424        |     P=0.676         P=0.008 **        (e)          |
|COCHRAN-ARMITAGE       |     P=0.427                                        |     P=0.692                                        |
|FISHER EXACT           |                     P=0.655         P=0.520        |                     P=0.123           (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)      14/50 (28%)     29/50 (58%)     |     5/50 (10%)      8/50 (16%)     20/49 (41%)     |
|ADJUSTED (b)           |      3.3%           54.8%           77.6%          |     12.2%           22.9%           49.1%          |
|TERMINAL (d)           |     1/30 (3%)       9/20 (45%)     13/21 (62%)     |     5/41 (12%)      8/35 (23%)     13/33 (39%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         485             476           |      731 (T)         731 (T)         589           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.179         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.179         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.179         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P=0.277         P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       2/50 (4%)      |     0/50 (0%)       3/50 (6%)       2/49 (4%)      |
|ADJUSTED (b)           |      3.3%            0.0%            8.3%          |      0.0%            8.3%            6.1%          |
|TERMINAL (d)           |     1/30 (3%)       0/20 (0%)       1/21 (5%)      |     0/41 (0%)       2/35 (6%)       2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         ---             670           |      ---             710             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.277         P=0.581N        P=0.385        |     P=0.155         P=0.097         P=0.192        |
|INCIDENTAL TUMOR       |     P=0.341         P=0.581N        P=0.479        |     P=0.181         P=0.118         P=0.192        |
|LOGISTIC REGRESSION    |     P=0.318         P=0.581N        P=0.444        |     P=0.166         P=0.105         P=0.192        |
|COCHRAN-ARMITAGE       |     P=0.360                                        |     P=0.196                                        |
|FISHER EXACT           |                     P=0.500N        P=0.500        |                     P=0.121         P=0.242        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)      14/50 (28%)     30/50 (60%)     |     5/50 (10%)     11/50 (22%)     22/49 (45%)     |
|ADJUSTED (b)           |      6.7%           54.8%           80.4%          |     12.2%           30.5%           54.2%          |
|TERMINAL (d)           |     2/30 (7%)       9/20 (45%)     14/21 (67%)     |     5/41 (12%)     10/35 (29%)     15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         485             476           |      731 (T)         710             589           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.042 *       P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.047 *       P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P<0.001 **      P<0.001 **     |     P<0.001 **      P=0.043 *       P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P<0.001 **      P<0.001 **     |                     P=0.086         P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       0/50 (0%)      |     1/50 (2%)       1/50 (2%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%           10.0%            0.0%          |      2.4%            2.3%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       2/20 (10%)      0/21 (0%)      |     1/41 (2%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         ---           |      731 (T)         675             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.583         P=0.154           (e)          |     P=0.381N        P=0.733         P=0.543N       |
|INCIDENTAL TUMOR       |     P=0.583         P=0.154           (e)          |     P=0.308N        P=0.751N        P=0.543N       |
|LOGISTIC REGRESSION    |     P=0.583         P=0.154           (e)          |     P=0.333N        P=0.761N        P=0.543N       |
|COCHRAN-ARMITAGE       |     P=0.669                                        |     P=0.335N                                       |
|FISHER EXACT           |                     P=0.247           (e)          |                     P=0.753N        P=0.505N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      4/50 (8%)      19/50 (38%)     |     3/50 (6%)       4/50 (8%)      17/49 (35%)     |
|ADJUSTED (b)           |     26.7%           18.5%           68.4%          |      7.3%           10.4%           48.2%          |
|TERMINAL (d)           |     8/30 (27%)      3/20 (15%)     13/21 (62%)     |     3/41 (7%)       2/35 (6%)      15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         691             366           |      731 (T)         616             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.413N        P<0.001 **     |     P<0.001 **      P=0.423         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.375N        P=0.002 **     |     P<0.001 **      P=0.552         P<0.001 **     |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.349N        P=0.004 **     |     P<0.001 **      P=0.487         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P=0.005 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.178N        P=0.012 *      |                     P=0.500         P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)     13/50 (26%)     12/50 (24%)     |     3/50 (6%)       3/50 (6%)       2/49 (4%)      |
|ADJUSTED (b)           |     19.4%           45.9%           38.3%          |      6.7%            8.6%            6.1%          |
|TERMINAL (d)           |     5/30 (17%)      6/20 (30%)      5/21 (24%)     |     1/41 (2%)       3/35 (9%)       2/33 (6%)      |
|FIRST INCIDENCE (DAYS) |      729             455             502           |      675             731 (T)         731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.027 *       P=0.012 *       P=0.031 *      |     P=0.514N        P=0.590         P=0.595N       |
|INCIDENTAL TUMOR       |     P=0.110         P=0.037 *       P=0.110        |     P=0.437N        P=0.653         P=0.478N       |
|LOGISTIC REGRESSION    |     P=0.064         P=0.023 *       P=0.078        |     P=0.461N        P=0.639         P=0.528N       |
|COCHRAN-ARMITAGE       |     P=0.087                                        |     P=0.421N                                       |
|FISHER EXACT           |                     P=0.062         P=0.096        |                     P=0.661N        P=0.510N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     17/50 (34%)     26/50 (52%)     |     6/50 (12%)      7/50 (14%)     17/49 (35%)     |
|ADJUSTED (b)           |     38.7%           59.3%           76.8%          |     13.7%           18.5%           48.2%          |
|TERMINAL (d)           |    11/30 (37%)      9/20 (45%)     14/21 (67%)     |     4/41 (10%)      5/35 (14%)     15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      729             455             366           |      675             616             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.023 *       P<0.001 **     |     P=0.001 **      P=0.392         P=0.002 **     |
|INCIDENTAL TUMOR       |     P=0.001 **      P=0.066         P=0.002 **     |     P=0.002 **      P=0.532         P=0.004 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.055         P=0.001 **     |     P=0.002 **      P=0.472         P=0.003 **     |
|COCHRAN-ARMITAGE       |     P=0.003 **                                     |     P=0.004 **                                     |
|FISHER EXACT           |                     P=0.189         P=0.004 **     |                     P=0.500         P=0.007 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     17/50 (34%)     26/50 (52%)     |     6/50 (12%)      7/50 (14%)     17/49 (35%)     |
|ADJUSTED (b)           |     38.7%           59.3%           76.8%          |     13.7%           18.5%           48.2%          |
|TERMINAL (d)           |    11/30 (37%)      9/20 (45%)     14/21 (67%)     |     4/41 (10%)      5/35 (14%)     15/33 (45%)     |
|FIRST INCIDENCE (DAYS) |      729             455             366           |      675             616             653           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.023 *       P<0.001 **     |     P=0.001 **      P=0.392         P=0.002 **     |
|INCIDENTAL TUMOR       |     P=0.001 **      P=0.066         P=0.002 **     |     P=0.002 **      P=0.532         P=0.004 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.055         P=0.001 **     |     P=0.002 **      P=0.472         P=0.003 **     |
|COCHRAN-ARMITAGE       |     P=0.003 **                                     |     P=0.004 **                                     |
|FISHER EXACT           |                     P=0.189         P=0.004 **     |                     P=0.500         P=0.007 **     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/49 (6%)       6/50 (12%)     11/50 (22%)     |     4/50 (8%)       4/50 (8%)       7/49 (14%)     |
|ADJUSTED (b)           |     10.3%           21.6%           40.1%          |      9.8%           10.8%           17.9%          |
|TERMINAL (d)           |     3/29 (10%)      2/20 (10%)      6/21 (29%)     |     4/41 (10%)      2/35 (6%)       4/33 (12%)     |
|FIRST INCIDENCE (DAYS) |      731 (T)         600             366           |      731 (T)         710             580           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.005 **      P=0.125         P=0.006 **     |     P=0.135         P=0.554         P=0.176        |
|INCIDENTAL TUMOR       |     P=0.015 *       P=0.191         P=0.019 *      |     P=0.219         P=0.612         P=0.293        |
|LOGISTIC REGRESSION    |     P=0.011 *       P=0.184         P=0.015 *      |     P=0.194         P=0.584         P=0.272        |
|COCHRAN-ARMITAGE       |     P=0.015 *                                      |     P=0.193                                        |
|FISHER EXACT           |                     P=0.254         P=0.022 *      |                     P=0.643N        P=0.251        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       4/50 (8%)      10/50 (20%)     |     2/50 (4%)       5/50 (10%)      7/49 (14%)     |
|ADJUSTED (b)           |      6.2%           18.3%           34.6%          |      4.9%           13.2%           19.2%          |
|TERMINAL (d)           |     1/29 (3%)       3/20 (15%)      4/21 (19%)     |     2/41 (5%)       4/35 (11%)      5/33 (15%)     |
|FIRST INCIDENCE (DAYS) |      675             687             589           |      731 (T)         421             580           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.003 **      P=0.209         P=0.006 **     |     P=0.034 *       P=0.167         P=0.045 *      |
|INCIDENTAL TUMOR       |     P=0.009 **      P=0.277         P=0.024 *      |     P=0.055         P=0.167         P=0.078        |
|LOGISTIC REGRESSION    |     P=0.005 **      P=0.253         P=0.011 *      |     P=0.061         P=0.243         P=0.076        |
|COCHRAN-ARMITAGE       |     P=0.008 **                                     |     P=0.057                                        |
|FISHER EXACT           |                     P=0.349         P=0.015 *      |                     P=0.218         P=0.075        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/49 (10%)     10/50 (20%)     18/50 (36%)     |     6/50 (12%)      8/50 (16%)     13/49 (27%)     |
|ADJUSTED (b)           |     16.3%           37.2%           58.2%          |     14.6%           20.6%           33.8%          |
|TERMINAL (d)           |     4/29 (14%)      5/20 (25%)      9/21 (43%)     |     6/41 (15%)      5/35 (14%)      9/33 (27%)     |
|FIRST INCIDENCE (DAYS) |      675             600             366           |      731 (T)         421             580           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.043 *       P<0.001 **     |     P=0.019 *       P=0.284         P=0.025 *      |
|INCIDENTAL TUMOR       |     P=0.001 **      P=0.083         P=0.002 **     |     P=0.043 *       P=0.322         P=0.054        |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.073         P=0.001 **     |     P=0.042 *       P=0.387         P=0.057        |
|COCHRAN-ARMITAGE       |     P=0.001 **                                     |     P=0.041 *                                      |
|FISHER EXACT           |                     P=0.140         P=0.002 **     |                     P=0.387         P=0.056        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       4/50 (8%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      4.9%            9.5%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       0/21 (0%)      |     2/41 (5%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      731 (T)         616             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.285N        P=0.287         P=0.287N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.139N        P=0.468         P=0.287N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.216N        P=0.358         P=0.287N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.228N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.339         P=0.253N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     3/50 (6%)       4/50 (8%)       1/49 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      7.1%            9.5%            2.6%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       0/21 (0%)      |     2/41 (5%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      716             616             674           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.332N        P=0.431         P=0.383N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.135N        P=0.653         P=0.263N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.146N        P=0.521         P=0.318N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.259N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.316N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     3/50 (6%)       4/50 (8%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      7.1%            9.5%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       0/21 (0%)      |     2/41 (5%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      716             616             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.169N        P=0.431         P=0.161N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.056N        P=0.653         P=0.119N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.115N        P=0.521         P=0.144N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.122N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.125N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     3/50 (6%)       4/50 (8%)       1/49 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      7.1%            9.5%            2.6%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       0/21 (0%)      |     2/41 (5%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      716             616             674           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.332N        P=0.431         P=0.383N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.135N        P=0.653         P=0.263N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.146N        P=0.521         P=0.318N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.259N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.500         P=0.316N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       5/45 (11%)      5/47 (11%)     |
|ADJUSTED (b)           |                                                    |      0.0%           16.1%           15.6%          |
|TERMINAL (d)           |                                                    |     0/41 (0%)       5/31 (16%)      5/32 (16%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             731 (T)         731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.017 *       P=0.015 *       P=0.016 *      |
|INCIDENTAL TUMOR       |                                                    |     P=0.017 *       P=0.015 *       P=0.016 *      |
|LOGISTIC REGRESSION    |                                                    |     P=0.017 *       P=0.015 *       P=0.016 *      |
|COCHRAN-ARMITAGE       |                                                    |     P=0.031 *                                      |
|FISHER EXACT           |                                                    |                     P=0.021 *       P=0.024 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/48 (0%)       1/14 (7%)       0/42 (0%)      |    13/49 (27%)      5/14 (36%)      4/43 (9%)      |
|ADJUSTED (b)           |      0.0%          100.0%            0.0%          |     30.1%           67.5%           12.5%          |
|TERMINAL (d)           |     0/30 (0%)       1/1 (100%)      0/20 (0%)      |    11/41 (27%)      4/6 (67%)       4/32 (13%)     |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         ---           |      690             690             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.623         P=0.004 **        (e)          |     P=0.058N        P=0.194         P=0.055N       |
|INCIDENTAL TUMOR       |     P=0.623         P=0.004 **        (e)          |     P=0.054N        P=0.062         P=0.049N*      |
|LOGISTIC REGRESSION    |     P=0.623         P=0.004 **        (e)          |     P=0.052N        P=0.059         P=0.046N*      |
|COCHRAN-ARMITAGE       |     P=0.684                                        |     P=0.031N*                                      |
|FISHER EXACT           |                     P=0.226           (e)          |                     P=0.360         P=0.030N*      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/48 (2%)       0/14 (0%)       0/42 (0%)      |     1/49 (2%)       0/14 (0%)       2/43 (5%)      |
|ADJUSTED (b)           |      2.9%            0.0%            0.0%          |      2.4%            0.0%            5.3%          |
|TERMINAL (d)           |     0/30 (0%)       0/1 (0%)        0/20 (0%)      |     1/41 (2%)       0/6 (0%)        1/32 (3%)      |
|FIRST INCIDENCE (DAYS) |      683             ---             ---           |      731 (T)         ---             589           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.309N        P=0.539N        P=0.554N       |     P=0.317         P=0.868N        P=0.435        |
|INCIDENTAL TUMOR       |     P=0.214N          (e)           P=0.393N       |     P=0.375         P=0.868N        P=0.561        |
|LOGISTIC REGRESSION    |     P=0.328N        P=0.932N        P=0.529N       |     P=0.351         P=0.868N        P=0.548        |
|COCHRAN-ARMITAGE       |     P=0.316N                                       |     P=0.337                                        |
|FISHER EXACT           |                     P=0.774N        P=0.533N       |                     P=0.778N        P=0.451        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/50 (8%)       0/50 (0%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     13.3%            0.0%           10.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     4/30 (13%)      0/20 (0%)       1/21 (5%)      |     0/41 (0%)       0/35 (0%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      731 (T)         ---             626           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.539N        P=0.123N        P=0.652N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.479N        P=0.123N        P=0.580N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.465N        P=0.123N        P=0.569N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.406N                                       |       (e)                                          |
|FISHER EXACT           |                     P=0.059N        P=0.500N       |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    15/50 (30%)     15/50 (30%)     11/50 (22%)     |     2/50 (4%)       2/50 (4%)       5/49 (10%)     |
|ADJUSTED (b)           |     39.4%           46.3%           36.3%          |      4.6%            4.8%           13.8%          |
|TERMINAL (d)           |     8/30 (27%)      4/20 (20%)      5/21 (24%)     |     1/41 (2%)       1/35 (3%)       3/33 (9%)      |
|FIRST INCIDENCE (DAYS) |      464             432             485           |      690             347             672           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.498N        P=0.271         P=0.520N       |     P=0.103         P=0.653         P=0.147        |
|INCIDENTAL TUMOR       |     P=0.103N        P=0.519N        P=0.173N       |     P=0.140         P=0.508N        P=0.241        |
|LOGISTIC REGRESSION    |     P=0.118N        P=0.450         P=0.273N       |     P=0.153         P=0.604N        P=0.208        |
|COCHRAN-ARMITAGE       |     P=0.216N                                       |     P=0.140                                        |
|FISHER EXACT           |                     P=0.586N        P=0.247N       |                     P=0.691N        P=0.210        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       3/50 (6%)       0/49 (0%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |      0.0%            7.7%            0.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       0/21 (0%)      |     0/41 (0%)       1/35 (3%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      ---             688             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.587         P=0.103           (e)          |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.579N        P=0.139           (e)          |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.632         P=0.118           (e)          |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.634                                        |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.121           (e)          |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    17/50 (34%)     15/50 (30%)     12/50 (24%)     |     2/50 (4%)       2/50 (4%)       5/49 (10%)     |
|ADJUSTED (b)           |     44.9%           46.3%           40.3%          |      4.6%            4.8%           13.8%          |
|TERMINAL (d)           |    10/30 (33%)      4/20 (20%)      6/21 (29%)     |     1/41 (2%)       1/35 (3%)       3/33 (9%)      |
|FIRST INCIDENCE (DAYS) |      464             432             485           |      690             347             672           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.450N        P=0.384         P=0.480N       |     P=0.103         P=0.653         P=0.147        |
|INCIDENTAL TUMOR       |     P=0.085N        P=0.372N        P=0.154N       |     P=0.140         P=0.508N        P=0.241        |
|LOGISTIC REGRESSION    |     P=0.193N        P=0.567N        P=0.220N       |     P=0.153         P=0.604N        P=0.208        |
|COCHRAN-ARMITAGE       |     P=0.161N                                       |     P=0.140                                        |
|FISHER EXACT           |                     P=0.415N        P=0.189N       |                     P=0.691N        P=0.210        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/26 (0%)       2/50 (4%)      |     0/50 (0%)       0/19 (0%)       1/48 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            9.5%          |      0.0%            0.0%            3.0%          |
|TERMINAL (d)           |     0/30 (0%)       0/4 (0%)        2/21 (10%)     |     0/41 (0%)       0/8 (0%)        1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             731 (T)       |      ---             ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.085           (e)           P=0.163        |     P=0.264           (e)           P=0.457        |
|INCIDENTAL TUMOR       |     P=0.085           (e)           P=0.163        |     P=0.264           (e)           P=0.457        |
|LOGISTIC REGRESSION    |     P=0.085           (e)           P=0.163        |     P=0.264           (e)           P=0.457        |
|COCHRAN-ARMITAGE       |     P=0.115                                        |     P=0.285                                        |
|FISHER EXACT           |                       (e)           P=0.247        |                       (e)           P=0.490        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/50 (2%)       2/50 (4%)      |     0/50 (0%)       0/50 (0%)       2/49 (4%)      |
|ADJUSTED (b)           |      0.0%            3.1%            8.3%          |      0.0%            0.0%            5.8%          |
|TERMINAL (d)           |     0/30 (0%)       0/20 (0%)       1/21 (5%)      |     0/41 (0%)       0/35 (0%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             634             670           |      ---             ---             729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.109         P=0.466         P=0.172        |     P=0.081           (e)           P=0.200        |
|INCIDENTAL TUMOR       |     P=0.162         P=0.545         P=0.254        |     P=0.107           (e)           P=0.262        |
|LOGISTIC REGRESSION    |     P=0.135         P=0.492         P=0.211        |     P=0.081           (e)           P=0.201        |
|COCHRAN-ARMITAGE       |     P=0.142                                        |     P=0.093                                        |
|FISHER EXACT           |                     P=0.500         P=0.247        |                       (e)           P=0.242        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       1/20 (5%)       2/49 (4%)      |     4/48 (8%)       0/6 (0%)        3/48 (6%)      |
|ADJUSTED (b)           |      0.0%            0.0%            9.0%          |      9.4%            0.0%            9.4%          |
|TERMINAL (d)           |     0/30 (0%)       0/0             1/20 (5%)      |     3/40 (8%)       0/0             3/32 (9%)      |
|FIRST INCIDENCE (DAYS) |      ---             617             691           |      655             ---             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.114         P=0.462         P=0.171        |     P=0.534N        P=0.517N        P=0.613N       |
|INCIDENTAL TUMOR       |     P=0.195         P=0.545         P=0.248        |     P=0.480N          (e)           P=0.558N       |
|LOGISTIC REGRESSION    |     P=0.154         P=0.205         P=0.193        |     P=0.467N        P=0.792N        P=0.537N       |
|COCHRAN-ARMITAGE       |     P=0.164                                        |     P=0.420N                                       |
|FISHER EXACT           |                     P=0.286         P=0.242        |                     P=0.615N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       1/50 (2%)       0/49 (0%)      |
|ADJUSTED (b)           |                                                    |      4.9%            2.9%            0.0%          |
|TERMINAL (d)           |                                                    |     2/41 (5%)       1/35 (3%)       0/33 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      731 (T)         731 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.182N        P=0.555N        P=0.287N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.182N        P=0.555N        P=0.287N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.182N        P=0.555N        P=0.287N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.145N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.253N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     4/50 (8%)       5/50 (10%)      1/49 (2%)      |
|ADJUSTED (b)           |      0.0%           10.0%            9.5%          |      9.3%           11.7%            3.0%          |
|TERMINAL (d)           |     0/30 (0%)       2/20 (10%)      2/21 (10%)     |     3/41 (7%)       1/35 (3%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         731 (T)       |      675             548             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.110         P=0.154         P=0.163        |     P=0.235N        P=0.430         P=0.254N       |
|INCIDENTAL TUMOR       |     P=0.110         P=0.154         P=0.163        |     P=0.111N        P=0.612         P=0.206N       |
|LOGISTIC REGRESSION    |     P=0.110         P=0.154         P=0.163        |     P=0.153N        P=0.537         P=0.202N       |
|COCHRAN-ARMITAGE       |     P=0.176                                        |     P=0.164N                                       |
|FISHER EXACT           |                     P=0.247         P=0.247        |                     P=0.500         P=0.187N       |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       2/50 (4%)       2/50 (4%)      |     5/50 (10%)      6/50 (12%)      1/49 (2%)      |
|ADJUSTED (b)           |      0.0%           10.0%            9.5%          |     11.7%           14.3%            3.0%          |
|TERMINAL (d)           |     0/30 (0%)       2/20 (10%)      2/21 (10%)     |     4/41 (10%)      2/35 (6%)       1/33 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             731 (T)         731 (T)       |      675             548             731 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.110         P=0.154         P=0.163        |     P=0.166N        P=0.417         P=0.163N       |
|INCIDENTAL TUMOR       |     P=0.110         P=0.154         P=0.163        |     P=0.076N        P=0.581         P=0.129N       |
|LOGISTIC REGRESSION    |     P=0.110         P=0.154         P=0.163        |     P=0.098N        P=0.524         P=0.124N       |
|COCHRAN-ARMITAGE       |     P=0.176                                        |     P=0.103N                                       |
|FISHER EXACT           |                     P=0.247         P=0.247        |                     P=0.500         P=0.107N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      6/50 (12%)      9/50 (18%)     |    16/50 (32%)     11/50 (22%)     21/49 (43%)     |
|ADJUSTED (b)           |     20.4%           24.4%           28.8%          |     35.4%           25.8%           48.4%          |
|TERMINAL (d)           |     2/30 (7%)       4/20 (20%)      3/21 (14%)     |    12/41 (29%)      5/35 (14%)     11/33 (33%)     |
|FIRST INCIDENCE (DAYS) |      432             501             257           |      655             592             527           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.284         P=0.590N        P=0.343        |     P=0.076         P=0.329N        P=0.086        |
|INCIDENTAL TUMOR       |     P=0.539         P=0.350N        P=0.558N       |     P=0.239         P=0.129N        P=0.260        |
|LOGISTIC REGRESSION    |     P=0.440         P=0.431N        P=0.505        |     P=0.220         P=0.119N        P=0.179        |
|COCHRAN-ARMITAGE       |     P=0.445                                        |     P=0.150                                        |
|FISHER EXACT           |                     P=0.387N        P=0.500        |                     P=0.184N        P=0.182        |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     8/50 (16%)      6/50 (12%)      9/50 (18%)     |    16/50 (32%)     11/50 (22%)     21/49 (43%)     |
|ADJUSTED (b)           |     20.4%           24.4%           28.8%          |     35.4%           25.8%           48.4%          |
|TERMINAL (d)           |     2/30 (7%)       4/20 (20%)      3/21 (14%)     |    12/41 (29%)      5/35 (14%)     11/33 (33%)     |
|FIRST INCIDENCE (DAYS) |      432             501             257           |      655             592             527           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.284         P=0.590N        P=0.343        |     P=0.076         P=0.329N        P=0.086        |
|INCIDENTAL TUMOR       |     P=0.539         P=0.350N        P=0.558N       |     P=0.239         P=0.129N        P=0.260        |
|LOGISTIC REGRESSION    |     P=0.440         P=0.431N        P=0.505        |     P=0.220         P=0.119N        P=0.179        |
|COCHRAN-ARMITAGE       |     P=0.445                                        |     P=0.150                                        |
|FISHER EXACT           |                     P=0.387N        P=0.500        |                     P=0.184N        P=0.182        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    16/50 (32%)     22/50 (44%)     38/50 (76%)     |    24/50 (48%)     24/50 (48%)     39/49 (80%)     |
|ADJUSTED (b)           |     49.8%           71.9%           92.5%          |     54.4%           59.8%           88.5%          |
|TERMINAL (d)           |    14/30 (47%)     12/20 (60%)     18/21 (86%)     |    21/41 (51%)     19/35 (54%)     28/33 (85%)     |
|FIRST INCIDENCE (DAYS) |      683             485             366           |      655             616             528           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.010 *       P<0.001 **     |     P<0.001 **      P=0.306         P<0.001 **     |
|INCIDENTAL TUMOR       |     P<0.001 **      P=0.035 *       P<0.001 **     |     P<0.001 **      P=0.444         P<0.001 **     |
|LOGISTIC REGRESSION    |     P<0.001 **      P=0.035 *       P<0.001 **     |     P<0.001 **      P=0.434         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P<0.001 **                                     |     P=0.001 **                                     |
|FISHER EXACT           |                     P=0.151         P<0.001 **     |                     P=0.579N        P=0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      VEHICLE         25 MG/KG        50 MG/KG      |      VEHICLE         25 MG/KG        50 MG/KG      |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    28/50 (56%)     33/50 (66%)     35/50 (70%)     |    24/50 (48%)     26/50 (52%)     33/49 (67%)     |
|ADJUSTED (b)           |     63.6%           86.8%           81.0%          |     51.0%           54.6%           71.7%          |
|TERMINAL (d)           |    14/30 (47%)     15/20 (75%)     13/21 (62%)     |    18/41 (44%)     14/35 (40%)     20/33 (61%)     |
|FIRST INCIDENCE (DAYS) |      432             432             257           |      655             347             527           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.017 *       P=0.025 *       P=0.026 *      |     P=0.014 *       P=0.239         P=0.014 *      |
|INCIDENTAL TUMOR       |     P=0.226         P=0.139         P=0.313        |     P=0.070         P=0.551N        P=0.063        |
|LOGISTIC REGRESSION    |     P=0.201         P=0.092         P=0.295        |     P=0.044 *       P=0.511         P=0.056        |
|COCHRAN-ARMITAGE       |     P=0.088                                        |     P=0.033 *                                      |
|FISHER EXACT           |                     P=0.206         P=0.107        |                     P=0.421         P=0.040 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    35/50 (70%)     39/50 (78%)     47/50 (94%)     |    33/50 (66%)     41/50 (82%)     47/49 (96%)     |
|ADJUSTED (b)           |     79.5%           97.5%           97.9%          |     70.2%           82.0%           97.9%          |
|TERMINAL (d)           |    21/30 (70%)     19/20 (95%)     20/21 (95%)     |    27/41 (66%)     26/35 (74%)     32/33 (97%)     |
|FIRST INCIDENCE (DAYS) |      432             432             257           |      655             347             527           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P<0.001 **      P=0.013 *       P=0.001 **     |     P<0.001 **      P=0.023 *       P<0.001 **     |
|INCIDENTAL TUMOR       |     P=0.002 **      P=0.064         P=0.009 **     |     P<0.001 **      P=0.086         P<0.001 **     |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.040 *       P=0.007 **     |     P<0.001 **      P=0.058         P<0.001 **     |
|COCHRAN-ARMITAGE       |     P=0.002 **                                     |     P<0.001 **                                     |
|FISHER EXACT           |                     P=0.247         P=0.002 **     |                     P=0.055         P<0.001 **     |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05024 TEST: 02                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- N-METHYLOLACRYLAMIDE
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).

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