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TDMS Study 88066-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: A. D. Little                                           POLYVINYL ALCOHOL                                  DATE: 08/14/96       
EXPERIMENT: 88066 TEST: 01                                                                                     TIME: 19:38:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15330                              ROUTE: VAGINAL                                                 NTP C#: 88066        
PATHOLOGIST: GOAD, MARY                                                                                        CAS: 9002-89-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                       VEHICLE CONTROL VS 25%                                                       
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 002    VEHICLE CONTROL                                                               
                                       INCLUDE 003    25%                                                                           
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: A. D. Little                                           POLYVINYL ALCOHOL                                  DATE: 08/14/96       
EXPERIMENT: 88066 TEST: 01                                                                                     TIME: 19:38:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-15330                              ROUTE: VAGINAL                                                 NTP C#: 88066        
PATHOLOGIST: GOAD, MARY                                                                                        CAS: 9002-89-5       




                                                    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 Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Salivary Glands
                                                    Spleen
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   1
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Adrenal Medulla                                                               |
|     Pheochromocytoma Benign                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/94 (2%)           0/92 (0%)                |
|ADJUSTED (b)           |          4.0%                0.0%                    |
|TERMINAL (d)           |         2/50 (4%)           0/55 (0%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.218N                 |
|INCIDENTAL TUMOR       |                             P=0.218N                 |
|LOGISTIC REGRESSION    |                             P=0.218N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.254N                 |
|==============================================================================|
|                                                                              |
|Harderian Gland                                                               |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         9/100 (9%)          4/100 (4%)               |
|ADJUSTED (b)           |         15.0%                6.3%                    |
|TERMINAL (d)           |         5/51 (10%)          3/61 (5%)                |
|FIRST INCIDENCE (DAYS) |          668                 690                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.081N                 |
|INCIDENTAL TUMOR       |                             P=0.121N                 |
|LOGISTIC REGRESSION    |                             P=0.107N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.125N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   2
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Harderian Gland                                                               |
|     Carcinoma                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          1/100 (1%)               |
|ADJUSTED (b)           |          2.5%                1.2%                    |
|TERMINAL (d)           |         0/51 (0%)           0/61 (0%)                |
|FIRST INCIDENCE (DAYS) |          620                 646                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.482N                 |
|INCIDENTAL TUMOR       |                             P=0.632N                 |
|LOGISTIC REGRESSION    |                             P=0.496N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
|                                                                              |
|Harderian Gland                                                               |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        11/100 (11%)         5/100 (5%)               |
|ADJUSTED (b)           |         17.1%                7.4%                    |
|TERMINAL (d)           |         5/51 (10%)          3/61 (5%)                |
|FIRST INCIDENCE (DAYS) |          620                 646                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.063N                 |
|INCIDENTAL TUMOR       |                             P=0.120N                 |
|LOGISTIC REGRESSION    |                             P=0.091N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.096N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   3
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Islets, Pancreatic                                                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/94 (3%)           1/97 (1%)                |
|ADJUSTED (b)           |          5.0%                1.6%                    |
|TERMINAL (d)           |         2/51 (4%)           1/61 (2%)                |
|FIRST INCIDENCE (DAYS) |          588                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.260N                 |
|INCIDENTAL TUMOR       |                             P=0.291N                 |
|LOGISTIC REGRESSION    |                             P=0.296N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.299N                 |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        56/99 (57%)         55/100 (55%)              |
|ADJUSTED (b)           |         80.5%               69.2%                    |
|TERMINAL (d)           |        38/51 (75%)         37/61 (61%)               |
|FIRST INCIDENCE (DAYS) |          611                 514                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.147N                 |
|INCIDENTAL TUMOR       |                             P=0.366N                 |
|LOGISTIC REGRESSION    |                             P=0.373N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.468N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   4
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        18/99 (18%)         20/100 (20%)              |
|ADJUSTED (b)           |         27.5%               28.0%                    |
|TERMINAL (d)           |         9/51 (18%)         13/61 (21%)               |
|FIRST INCIDENCE (DAYS) |          548                 507                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.533N                 |
|INCIDENTAL TUMOR       |                             P=0.416                  |
|LOGISTIC REGRESSION    |                             P=0.452                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.442                  |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        61/99 (62%)         62/100 (62%)              |
|ADJUSTED (b)           |         82.9%               73.4%                    |
|TERMINAL (d)           |        39/51 (76%)         39/61 (64%)               |
|FIRST INCIDENCE (DAYS) |          548                 507                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.213N                 |
|INCIDENTAL TUMOR       |                             P=0.540N                 |
|LOGISTIC REGRESSION    |                             P=0.535N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.536                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   5
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        61/99 (62%)         62/100 (62%)              |
|ADJUSTED (b)           |         82.9%               73.4%                    |
|TERMINAL (d)           |        39/51 (76%)         39/61 (64%)               |
|FIRST INCIDENCE (DAYS) |          548                 507                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.213N                 |
|INCIDENTAL TUMOR       |                             P=0.540N                 |
|LOGISTIC REGRESSION    |                             P=0.535N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.536                  |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocholangiocarcinoma                                                 |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/99 (0%)           2/100 (2%)               |
|ADJUSTED (b)           |          0.0%                2.2%                    |
|TERMINAL (d)           |         0/51 (0%)           0/61 (0%)                |
|FIRST INCIDENCE (DAYS) |          ---                 553                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.249                  |
|INCIDENTAL TUMOR       |                             P=0.157                  |
|LOGISTIC REGRESSION    |                             P=0.252                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.251                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   6
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Adenoma                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         7/98 (7%)           8/100 (8%)               |
|ADJUSTED (b)           |         11.8%               11.7%                    |
|TERMINAL (d)           |         3/51 (6%)           6/61 (10%)               |
|FIRST INCIDENCE (DAYS) |          611                 313                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.603                  |
|INCIDENTAL TUMOR       |                             P=0.552                  |
|LOGISTIC REGRESSION    |                             P=0.516                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.516                  |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma                                           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/98 (3%)           5/100 (5%)               |
|ADJUSTED (b)           |          5.0%                7.8%                    |
|TERMINAL (d)           |         2/51 (4%)           4/61 (7%)                |
|FIRST INCIDENCE (DAYS) |          548                 675                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.437                  |
|INCIDENTAL TUMOR       |                             P=0.392                  |
|LOGISTIC REGRESSION    |                             P=0.377                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.372                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   7
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Lung                                                                          |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma           |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        10/98 (10%)         13/100 (13%)              |
|ADJUSTED (b)           |         16.4%               19.3%                    |
|TERMINAL (d)           |         5/51 (10%)         10/61 (16%)               |
|FIRST INCIDENCE (DAYS) |          548                 313                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.461                  |
|INCIDENTAL TUMOR       |                             P=0.390                  |
|LOGISTIC REGRESSION    |                             P=0.349                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.348                  |
|==============================================================================|
|                                                                              |
|Ovary                                                                         |
|     Cystadenoma                                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         5/97 (5%)           3/97 (3%)                |
|ADJUSTED (b)           |          9.4%                4.8%                    |
|TERMINAL (d)           |         4/51 (8%)           2/59 (3%)                |
|FIRST INCIDENCE (DAYS) |          711                 690                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.290N                 |
|INCIDENTAL TUMOR       |                             P=0.331N                 |
|LOGISTIC REGRESSION    |                             P=0.320N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.360N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   8
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Ovary                                                                         |
|     Granulosa Cell Tumor Benign                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/97 (2%)           0/97 (0%)                |
|ADJUSTED (b)           |          3.9%                0.0%                    |
|TERMINAL (d)           |         2/51 (4%)           0/59 (0%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.207N                 |
|INCIDENTAL TUMOR       |                             P=0.207N                 |
|LOGISTIC REGRESSION    |                             P=0.207N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.249N                 |
|==============================================================================|
|                                                                              |
|Ovary                                                                         |
|     Luteoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/97 (0%)           2/97 (2%)                |
|ADJUSTED (b)           |          0.0%                3.0%                    |
|TERMINAL (d)           |         0/51 (0%)           1/59 (2%)                |
|FIRST INCIDENCE (DAYS) |          ---                 658                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.262                  |
|INCIDENTAL TUMOR       |                             P=0.229                  |
|LOGISTIC REGRESSION    |                             P=0.240                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.249                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE   9
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Ovary                                                                         |
|     Yolk Sac Carcinoma                                                       |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         0/97 (0%)           2/97 (2%)                |
|ADJUSTED (b)           |          0.0%                2.7%                    |
|TERMINAL (d)           |         0/51 (0%)           1/59 (2%)                |
|FIRST INCIDENCE (DAYS) |          ---                 372                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.256                  |
|INCIDENTAL TUMOR       |                             P=0.313                  |
|LOGISTIC REGRESSION    |                             P=0.259                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.249                  |
|==============================================================================|
|                                                                              |
|Pituitary Gland: Pars Distalis or Unspecified Site                            |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         9/86 (10%)         10/84 (12%)               |
|ADJUSTED (b)           |         14.9%               16.5%                    |
|TERMINAL (d)           |         4/47 (9%)           6/50 (12%)               |
|FIRST INCIDENCE (DAYS) |          620                 634                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.559                  |
|INCIDENTAL TUMOR       |                             P=0.445                  |
|LOGISTIC REGRESSION    |                             P=0.478                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.478                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  10
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Skeletal Muscle                                                               |
|     Rhabdomyosarcoma                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          2/100 (2%)               |
|ADJUSTED (b)           |          2.7%                3.3%                    |
|TERMINAL (d)           |         0/51 (0%)           2/61 (3%)                |
|FIRST INCIDENCE (DAYS) |          548                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.649N                 |
|INCIDENTAL TUMOR       |                             P=0.662                  |
|LOGISTIC REGRESSION    |                             P=0.693N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.689N                 |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Fibrosarcoma                                                             |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          1/100 (1%)               |
|ADJUSTED (b)           |          3.1%                1.6%                    |
|TERMINAL (d)           |         0/51 (0%)           1/61 (2%)                |
|FIRST INCIDENCE (DAYS) |          675                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.455N                 |
|INCIDENTAL TUMOR       |                             P=0.543N                 |
|LOGISTIC REGRESSION    |                             P=0.493N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  11
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Adenoma                                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         9/96 (9%)          11/100 (11%)              |
|ADJUSTED (b)           |         15.8%               16.7%                    |
|TERMINAL (d)           |         6/51 (12%)          8/61 (13%)               |
|FIRST INCIDENCE (DAYS) |          634                 637                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.549                  |
|INCIDENTAL TUMOR       |                             P=0.445                  |
|LOGISTIC REGRESSION    |                             P=0.472                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.445                  |
|==============================================================================|
|                                                                              |
|Thyroid Gland: Follicular Cell                                                |
|     Carcinoma or Adenoma                                                     |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |        10/96 (10%)         11/100 (11%)              |
|ADJUSTED (b)           |         17.6%               16.7%                    |
|TERMINAL (d)           |         7/51 (14%)          8/61 (13%)               |
|FIRST INCIDENCE (DAYS) |          634                 637                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.535N                 |
|INCIDENTAL TUMOR       |                             P=0.547                  |
|LOGISTIC REGRESSION    |                             P=0.571                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.540                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  12
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Uterus                                                                        |
|     Polyp Stromal                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/100 (1%)          3/100 (3%)               |
|ADJUSTED (b)           |          2.0%                4.4%                    |
|TERMINAL (d)           |         1/51 (2%)           2/61 (3%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             620                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.362                  |
|INCIDENTAL TUMOR       |                             P=0.315                  |
|LOGISTIC REGRESSION    |                             P=0.315                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.311                  |
|==============================================================================|
|                                                                              |
|Uterus                                                                        |
|     Sarcoma Stromal                                                          |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          0/100 (0%)               |
|ADJUSTED (b)           |          3.9%                0.0%                    |
|TERMINAL (d)           |         2/51 (4%)           0/61 (0%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             ---                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.200N                 |
|INCIDENTAL TUMOR       |                             P=0.200N                 |
|LOGISTIC REGRESSION    |                             P=0.200N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.249N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  13
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|Uterus                                                                        |
|     Sarcoma Stromal or Polyp Stromal                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/100 (3%)          3/100 (3%)               |
|ADJUSTED (b)           |          5.9%                4.4%                    |
|TERMINAL (d)           |         3/51 (6%)           2/61 (3%)                |
|FIRST INCIDENCE (DAYS) |          729 (T)             620                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.585N                 |
|INCIDENTAL TUMOR       |                             P=0.626N                 |
|LOGISTIC REGRESSION    |                             P=0.639N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.659N                 |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Histiocytic Sarcoma                                                      |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/100 (2%)          1/100 (1%)               |
|ADJUSTED (b)           |          2.3%                1.6%                    |
|TERMINAL (d)           |         0/51 (0%)           1/61 (2%)                |
|FIRST INCIDENCE (DAYS) |          588                 729 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.475N                 |
|INCIDENTAL TUMOR       |                             P=0.580N                 |
|LOGISTIC REGRESSION    |                             P=0.499N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  14
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferenti|ted
|     Cell Type                                                                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        14/100 (14%)        18/100 (18%)              |
|ADJUSTED (b)           |         23.0%               25.8%                    |
|TERMINAL (d)           |         8/51 (16%)         12/61 (20%)               |
|FIRST INCIDENCE (DAYS) |          627                 624                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.447                  |
|INCIDENTAL TUMOR       |                             P=0.264                  |
|LOGISTIC REGRESSION    |                             P=0.316                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.282                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        72/100 (72%)        69/100 (69%)              |
|ADJUSTED (b)           |         92.1%               81.9%                    |
|TERMINAL (d)           |        45/51 (88%)         46/61 (75%)               |
|FIRST INCIDENCE (DAYS) |          588                 313                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.070N                 |
|INCIDENTAL TUMOR       |                             P=0.298N                 |
|LOGISTIC REGRESSION    |                             P=0.292N                 |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.378N                 |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  15
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       TERMINAL SACRIFICE AT 105 WEEKS

|==============================================================================|
|DOSE                   |          VEHICLE             25%                     |
|                       |          CONTROL                                     |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        42/100 (42%)        51/100 (51%)              |
|ADJUSTED (b)           |         55.9%               60.9%                    |
|TERMINAL (d)           |        21/51 (41%)         30/61 (49%)               |
|FIRST INCIDENCE (DAYS) |          548                 324                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.397                  |
|INCIDENTAL TUMOR       |                             P=0.088                  |
|LOGISTIC REGRESSION    |                             P=0.089                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.128                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |        82/100 (82%)        88/100 (88%)              |
|ADJUSTED (b)           |         96.4%               91.6%                    |
|TERMINAL (d)           |        48/51 (94%)         53/61 (87%)               |
|FIRST INCIDENCE (DAYS) |          548                 313                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.314N                 |
|INCIDENTAL TUMOR       |                             P=0.118                  |
|LOGISTIC REGRESSION    |                             P=0.141                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.161                  |
|==============================================================================|
         DATE: 08/15/96                     EXPERIMENT: 88066 TEST: 01                                                 PAGE  16
  STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(B6C3F1) -- POLYVINYL ALCOHOL

                       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).