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TDMS Study 05025-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  ETHYLENE GLYCOL                                   DATE: 09/04/94       
EXPERIMENT: 05025 TEST: 01                                                                                     TIME: 06:15:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 00920A       
PATHOLOGIST: D. FARNELL                      S. EUSTIS                                                         CAS: 107-21-1        
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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: Southern Research Inst                                  ETHYLENE GLYCOL                                   DATE: 09/04/94      
EXPERIMENT: 05025 TEST: 01                                                                                     TIME: 06:15:46      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 00920A      
PATHOLOGIST: D. FARNELL                      S. EUSTIS                                                         CAS: 107-21-1       
 
 
 
 
 
                                                    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
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  ETHYLENE GLYCOL                                   DATE: 09/04/94       
EXPERIMENT: 05025 TEST: 01                                                                                     TIME: 06:15:46       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01CP9565102          ROUTE: DOSED FEED                                                                  NTP C#: 00920A       
PATHOLOGIST: D. FARNELL                      S. EUSTIS                                                         CAS: 107-21-1        
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF ETHYLENE GLYCOL
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Harderian Gland               Carcinoma or Adenoma
                             Lung                          Alveolar/Bronchiolar Adenoma
                                                           Alveolar/Bronchiolar Carcinoma
                                                           Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Benign Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             All Organs                    Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
 
              ====================================================================================================
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/54 (7%)    0/20 (0%)    0/21 (0%)    3/54 (6%)  |  0/49 (0%)    0/21 (0%)    0/21 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  13.8%         0.0%         0.0%        13.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  4/29 (14%)   0/0          0/0          3/23 (13%) |  0/33 (0%)    0/1 (0%)     0/0          0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          ---          731 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.550N       (e)          (e)        P=0.628N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.550N       (e)          (e)        P=0.628N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.550N       (e)          (e)        P=0.628N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.495N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.275N     P=0.260N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/54 (2%)    1/21 (5%)    0/21 (0%)    0/53 (0%)  |  0/48 (0%)    2/21 (10%)   1/21 (5%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.4%       100.0%         0.0%         0.0%      |   0.0%       100.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    1/1 (100%)   0/0          0/23 (0%)  |  0/32 (0%)    1/1 (100%)   0/0          0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      ---          ---       |   ---          633          500          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.292N     P=0.041 *      (e)        P=0.546N   |  P=0.407N     P=0.032 *    P=0.496        (e)      |
|INCIDENTAL TUMOR       |  P=0.292N     P=0.041 *      (e)        P=0.546N   |  P=0.453N     P=0.045 *    P=0.581        (e)      |
|LOGISTIC REGRESSION    |  P=0.290N     P=0.041 *      (e)        P=0.546N   |  P=0.418N     P=0.039 *    P=0.552        (e)      |
|COCHRAN-ARMITAGE       |  P=0.243N                                          |  P=0.414N                                          |
|FISHER EXACT           |               P=0.484      P=0.720N     P=0.505N   |               P=0.090      P=0.304        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/54 (0%)    0/54 (0%)    2/54 (4%)    2/54 (4%)  |  2/50 (4%)    1/50 (2%)    1/51 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.3%         7.5%      |   6.1%         3.3%         3.3%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    2/32 (6%)    1/23 (4%)  |  2/33 (6%)    1/30 (3%)    1/30 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          731 (T)      681       |   731 (T)      731 (T)      731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055        (e)        P=0.260      P=0.211    |  P=0.137N     P=0.533N     P=0.533N     P=0.213N   |
|INCIDENTAL TUMOR       |  P=0.073        (e)        P=0.260      P=0.274    |  P=0.137N     P=0.533N     P=0.533N     P=0.213N   |
|LOGISTIC REGRESSION    |  P=0.059        (e)        P=0.260      P=0.209    |  P=0.137N     P=0.533N     P=0.533N     P=0.213N   |
|COCHRAN-ARMITAGE       |  P=0.086                                           |  P=0.152N                                          |
|FISHER EXACT           |                 (e)        P=0.248      P=0.248    |               P=0.500N     P=0.492N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/54 (0%)    0/54 (0%)    0/54 (0%)    1/54 (2%)  |  0/50 (0%)    1/50 (2%)    1/51 (2%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         4.3%      |   0.0%         3.3%         3.0%         5.4%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    0/32 (0%)    1/23 (4%)  |  0/33 (0%)    1/30 (3%)    0/30 (0%)    2/37 (5%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          731 (T)   |   ---          731 (T)      700          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.160        (e)          (e)        P=0.454    |  P=0.190      P=0.481      P=0.500      P=0.264    |
|INCIDENTAL TUMOR       |  P=0.160        (e)          (e)        P=0.454    |  P=0.172      P=0.481      P=0.500      P=0.264    |
|LOGISTIC REGRESSION    |  P=0.160        (e)          (e)        P=0.454    |  P=0.174      P=0.481      P=0.497      P=0.264    |
|COCHRAN-ARMITAGE       |  P=0.198                                           |  P=0.153                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.500      P=0.505      P=0.247    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/54 (0%)    0/54 (0%)    2/54 (4%)    3/54 (6%)  |  2/50 (4%)    2/50 (4%)    2/51 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         0.0%         6.3%        11.7%      |   6.1%         6.7%         6.3%         5.4%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    2/32 (6%)    2/23 (9%)  |  2/33 (6%)    2/30 (7%)    1/30 (3%)    2/37 (5%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          731 (T)      681       |   731 (T)      731 (T)      700          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.014 *      (e)        P=0.260      P=0.095    |  P=0.533N     P=0.661      P=0.668      P=0.654N   |
|INCIDENTAL TUMOR       |  P=0.019 *      (e)        P=0.260      P=0.125    |  P=0.549N     P=0.661      P=0.668      P=0.654N   |
|LOGISTIC REGRESSION    |  P=0.016 *      (e)        P=0.260      P=0.098    |  P=0.550N     P=0.661      P=0.680      P=0.654N   |
|COCHRAN-ARMITAGE       |  P=0.028 *                                         |  P=0.596N                                          |
|FISHER EXACT           |                 (e)        P=0.248      P=0.121    |               P=0.691N     P=0.684N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Polyp Adenomatous                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/54 (4%)    0/54 (0%)    0/54 (0%)    1/54 (2%)  |  0/50 (0%)    0/50 (0%)    0/51 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.9%         0.0%         0.0%         4.3%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/29 (7%)    0/32 (0%)    0/32 (0%)    1/23 (4%)  |  0/33 (0%)    0/30 (0%)    0/30 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          ---          731 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.523N     P=0.216N     P=0.216N     P=0.581N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.523N     P=0.216N     P=0.216N     P=0.581N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.523N     P=0.216N     P=0.216N     P=0.581N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.461N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  9/54 (17%)   6/53 (11%)   5/53 (9%)   10/54 (19%) |  8/50 (16%)   5/50 (10%)   8/51 (16%)   7/50 (14%) |
|ADJUSTED (b)           |  29.3%        17.4%        15.6%        38.7%      |  22.7%        15.7%        22.9%        18.1%      |
|TERMINAL (d)           |  8/29 (28%)   5/32 (16%)   5/32 (16%)   8/23 (35%) |  6/33 (18%)   4/30 (13%)   5/30 (17%)   6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   469          599          731 (T)      317       |   696          679          634          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.180      P=0.211N     P=0.140N     P=0.292    |  P=0.444N     P=0.338N     P=0.540      P=0.414N   |
|INCIDENTAL TUMOR       |  P=0.214      P=0.233N     P=0.133N     P=0.352    |  P=0.541N     P=0.323N     P=0.587      P=0.488N   |
|LOGISTIC REGRESSION    |  P=0.229      P=0.192N     P=0.159N     P=0.377    |  P=0.505N     P=0.303N     P=0.583      P=0.449N   |
|COCHRAN-ARMITAGE       |  P=0.374                                           |  P=0.553N                                          |
|FISHER EXACT           |               P=0.303N     P=0.206N     P=0.500    |               P=0.277N     P=0.590N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 10/54 (19%)  17/53 (32%)  12/53 (23%)   9/54 (17%) |  3/50 (6%)    5/50 (10%)   6/51 (12%)   3/50 (6%)  |
|ADJUSTED (b)           |  26.4%        41.0%        30.8%        28.0%      |   7.7%        15.3%        17.9%         7.2%      |
|TERMINAL (d)           |  3/29 (10%)   8/32 (25%)   6/32 (19%)   2/23 (9%)  |  0/33 (0%)    3/30 (10%)   4/30 (13%)   1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   538          601          517          519       |   655          679          612          659       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.451N     P=0.199      P=0.485      P=0.557    |  P=0.443N     P=0.320      P=0.219      P=0.619N   |
|INCIDENTAL TUMOR       |  P=0.312N     P=0.230      P=0.365      P=0.521N   |  P=0.546N     P=0.325      P=0.235      P=0.627    |
|LOGISTIC REGRESSION    |  P=0.534N     P=0.189      P=0.341      P=0.481    |  P=0.449N     P=0.344      P=0.238      P=0.620N   |
|COCHRAN-ARMITAGE       |  P=0.250N                                          |  P=0.516N                                          |
|FISHER EXACT           |               P=0.082      P=0.387      P=0.500N   |               P=0.357      P=0.254      P=0.661N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/54 (35%)  23/53 (43%)  16/53 (30%)  18/54 (33%) | 10/50 (20%)   9/50 (18%)  14/51 (27%)  10/50 (20%) |
|ADJUSTED (b)           |  50.2%        54.3%        41.5%        56.6%      |  26.5%        27.9%        38.6%        24.4%      |
|TERMINAL (d)           | 11/29 (38%)  13/32 (41%)  10/32 (31%)  10/23 (43%) |  6/33 (18%)   7/30 (23%)   9/30 (30%)   7/37 (19%) |
|FIRST INCIDENCE (DAYS) |   469          599          517          317       |   655          679          612          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.448      P=0.472      P=0.258N     P=0.397    |  P=0.484N     P=0.581N     P=0.195      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.514N     P=0.550      P=0.309N     P=0.510    |  P=0.466      P=0.565N     P=0.222      P=0.587    |
|LOGISTIC REGRESSION    |  P=0.427      P=0.457      P=0.333N     P=0.399    |  P=0.537N     P=0.539N     P=0.278      P=0.573N   |
|COCHRAN-ARMITAGE       |  P=0.309N                                          |  P=0.468                                           |
|FISHER EXACT           |               P=0.251      P=0.365N     P=0.500N   |               P=0.500N     P=0.260      P=0.598N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 19/54 (35%)  23/53 (43%)  16/53 (30%)  18/54 (33%) | 10/50 (20%)   9/50 (18%)  14/51 (27%)  10/50 (20%) |
|ADJUSTED (b)           |  50.2%        54.3%        41.5%        56.6%      |  26.5%        27.9%        38.6%        24.4%      |
|TERMINAL (d)           | 11/29 (38%)  13/32 (41%)  10/32 (31%)  10/23 (43%) |  6/33 (18%)   7/30 (23%)   9/30 (30%)   7/37 (19%) |
|FIRST INCIDENCE (DAYS) |   469          599          517          317       |   655          679          612          639       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.448      P=0.472      P=0.258N     P=0.397    |  P=0.484N     P=0.581N     P=0.195      P=0.500N   |
|INCIDENTAL TUMOR       |  P=0.514N     P=0.550      P=0.309N     P=0.510    |  P=0.466      P=0.565N     P=0.222      P=0.587    |
|LOGISTIC REGRESSION    |  P=0.427      P=0.457      P=0.333N     P=0.399    |  P=0.537N     P=0.539N     P=0.278      P=0.573N   |
|COCHRAN-ARMITAGE       |  P=0.309N                                          |  P=0.468                                           |
|FISHER EXACT           |               P=0.251      P=0.365N     P=0.500N   |               P=0.500N     P=0.260      P=0.598N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/54 (13%)   2/25 (8%)    8/32 (25%)   3/54 (6%)  |  0/50 (0%)    4/50 (8%)    4/51 (8%)    1/50 (2%)  |
|ADJUSTED (b)           |  24.1%        50.0%        80.0%        11.1%      |   0.0%        10.9%        12.0%         2.7%      |
|TERMINAL (d)           |  7/29 (24%)   2/4 (50%)    8/10 (80%)   2/23 (9%)  |  0/33 (0%)    2/30 (7%)    3/30 (10%)   1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      731 (T)      386       |   ---          472          548          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.275N     P=0.315      P=0.003 **   P=0.260N   |  P=0.566N     P=0.058      P=0.055      P=0.523    |
|INCIDENTAL TUMOR       |  P=0.272N     P=0.315      P=0.003 **   P=0.266N   |  P=0.544      P=0.076      P=0.065      P=0.523    |
|LOGISTIC REGRESSION    |  P=0.243N     P=0.315      P=0.003 **   P=0.211N   |  P=0.568      P=0.068      P=0.063      P=0.523    |
|COCHRAN-ARMITAGE       |  P=0.195N                                          |  P=0.570                                           |
|FISHER EXACT           |               P=0.410N     P=0.130      P=0.160N   |               P=0.059      P=0.061      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/54 (2%)    2/25 (8%)    2/32 (6%)    0/54 (0%)  |  1/50 (2%)    2/50 (4%)    2/51 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.4%        50.0%        20.0%         0.0%      |   3.0%         6.2%         6.5%         0.0%      |
|TERMINAL (d)           |  1/29 (3%)    2/4 (50%)    2/10 (20%)   0/23 (0%)  |  1/33 (3%)    1/30 (3%)    1/30 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      731 (T)      ---       |   731 (T)      696          730          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.321N     P=0.019 *    P=0.160      P=0.546N   |  P=0.269N     P=0.468      P=0.471      P=0.477N   |
|INCIDENTAL TUMOR       |  P=0.321N     P=0.019 *    P=0.160      P=0.546N   |  P=0.291N     P=0.478      P=0.478      P=0.477N   |
|LOGISTIC REGRESSION    |  P=0.321N     P=0.019 *    P=0.160      P=0.546N   |  P=0.273N     P=0.485      P=0.478      P=0.477N   |
|COCHRAN-ARMITAGE       |  P=0.269N                                          |  P=0.295N                                          |
|FISHER EXACT           |               P=0.234      P=0.310      P=0.500N   |               P=0.500      P=0.508      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/54 (13%)   3/25 (12%)   9/32 (28%)   3/54 (6%)  |  1/50 (2%)    6/50 (12%)   6/51 (12%)   1/50 (2%)  |
|ADJUSTED (b)           |  24.1%        75.0%        90.0%        11.1%      |   3.0%        16.6%        18.0%         2.7%      |
|TERMINAL (d)           |  7/29 (24%)   3/4 (75%)    9/10 (90%)   2/23 (9%)  |  1/33 (3%)    3/30 (10%)   4/30 (13%)   1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      731 (T)      386       |   731 (T)      472          548          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.256N     P=0.071      P<0.001 **   P=0.260N   |  P=0.337N     P=0.051      P=0.049 *    P=0.736N   |
|INCIDENTAL TUMOR       |  P=0.253N     P=0.071      P<0.001 **   P=0.266N   |  P=0.404N     P=0.065      P=0.057      P=0.736N   |
|LOGISTIC REGRESSION    |  P=0.208N     P=0.071      P<0.001 **   P=0.211N   |  P=0.384N     P=0.060      P=0.054      P=0.736N   |
|COCHRAN-ARMITAGE       |  P=0.178N                                          |  P=0.388N                                          |
|FISHER EXACT           |               P=0.608N     P=0.074      P=0.160N   |               P=0.056      P=0.059      P=0.753N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  2/49 (4%)    1/25 (4%)    1/25 (4%)    4/48 (8%)  |
|ADJUSTED (b)           |                                                    |   5.3%        20.0%        16.7%        10.0%      |
|TERMINAL (d)           |                                                    |  0/32 (0%)    1/5 (20%)    1/6 (17%)    2/35 (6%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   606          731 (T)      731 (T)      469       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.277      P=0.689N     P=0.667N     P=0.371    |
|INCIDENTAL TUMOR       |                                                    |  P=0.219      P=0.641N     P=0.646N     P=0.264    |
|LOGISTIC REGRESSION    |                                                    |  P=0.227      P=0.730      P=0.727      P=0.325    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.224                                           |
|FISHER EXACT           |                                                    |               P=0.738N     P=0.738N     P=0.329    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/52 (0%)    0/21 (0%)    0/17 (0%)    0/49 (0%)  | 17/47 (36%)   5/22 (23%)   7/23 (30%)  16/47 (34%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  47.8%       100.0%       100.0%        45.7%      |
|TERMINAL (d)           |  0/27 (0%)    0/0          0/0          0/23 (0%)  | 14/32 (44%)   2/2 (100%)   3/3 (100%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   578          644          612          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.266N     P=0.321      P=0.156      P=0.375N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.339N     P=0.441      P=0.182      P=0.456N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.325N     P=0.502      P=0.227      P=0.409N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.538                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.202N     P=0.422N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/52 (0%)    0/21 (0%)    0/17 (0%)    0/49 (0%)  | 17/47 (36%)   5/22 (23%)   8/23 (35%)  16/47 (34%) |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  47.8%       100.0%       100.0%        45.7%      |
|TERMINAL (d)           |  0/27 (0%)    0/0          0/0          0/23 (0%)  | 14/32 (44%)   2/2 (100%)   3/3 (100%)  16/35 (46%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   578          644          500          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.278N     P=0.321      P=0.102      P=0.375N   |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.352N     P=0.441      P=0.131      P=0.456N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.360N     P=0.502      P=0.197      P=0.409N   |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.531                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.202N     P=0.564N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/54 (4%)    2/54 (4%)    1/54 (2%)    2/54 (4%)  |  0/50 (0%)    0/50 (0%)    0/51 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.9%         6.3%         3.1%         8.7%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/29 (7%)    2/32 (6%)    1/32 (3%)    2/23 (9%)  |  0/33 (0%)    0/30 (0%)    0/30 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      731 (T)      731 (T)      731 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.538      P=0.660N     P=0.465N     P=0.610    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.538      P=0.660N     P=0.465N     P=0.610    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.538      P=0.660N     P=0.465N     P=0.610    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.577N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.691N     P=0.500N     P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/54 (6%)    8/54 (15%)   6/54 (11%)   1/54 (2%)  |  0/50 (0%)    0/50 (0%)    2/51 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.5%        19.8%        15.6%         3.7%      |   0.0%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    4/32 (13%)   2/32 (6%)    0/23 (0%)  |  0/33 (0%)    0/30 (0%)    2/30 (7%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   598          514          584          697       |   ---          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.222N     P=0.168      P=0.287      P=0.350N   |  P=0.620        (e)        P=0.217        (e)      |
|INCIDENTAL TUMOR       |  P=0.246N     P=0.150      P=0.171      P=0.207N   |  P=0.620        (e)        P=0.217        (e)      |
|LOGISTIC REGRESSION    |  P=0.263N     P=0.116      P=0.161      P=0.417N   |  P=0.620        (e)        P=0.217        (e)      |
|COCHRAN-ARMITAGE       |  P=0.140N                                          |  P=0.596                                           |
|FISHER EXACT           |               P=0.101      P=0.244      P=0.309N   |                 (e)        P=0.252        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/54 (11%)  11/54 (20%)   7/54 (13%)   5/54 (9%)  |  1/50 (2%)    0/50 (0%)    2/51 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |  16.6%        27.1%        18.0%        17.5%      |   2.7%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  2/29 (7%)    6/32 (19%)   2/32 (6%)    2/23 (9%)  |  0/33 (0%)    0/30 (0%)    2/30 (7%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   350          514          584          595       |   696          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.417N     P=0.240      P=0.554      P=0.607N   |  P=0.434N     P=0.517N     P=0.465      P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.396N     P=0.166      P=0.407      P=0.479N   |  P=0.450N     P=0.500N     P=0.478      P=0.531N   |
|LOGISTIC REGRESSION    |  P=0.460N     P=0.161      P=0.511      P=0.566N   |  P=0.442N     P=0.503N     P=0.486      P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.261N                                          |  P=0.460N                                          |
|FISHER EXACT           |               P=0.145      P=0.500      P=0.500N   |               P=0.500N     P=0.508      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/54 (7%)    9/54 (17%)   7/54 (13%)   3/54 (6%)  |  1/50 (2%)    0/50 (0%)    2/51 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |  10.5%        21.4%        18.0%         9.7%      |   2.7%         0.0%         6.7%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    4/32 (13%)   2/32 (6%)    0/23 (0%)  |  0/33 (0%)    0/30 (0%)    2/30 (7%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   350          514          584          595       |   696          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.393N     P=0.199      P=0.313      P=0.564N   |  P=0.434N     P=0.517N     P=0.465      P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.367N     P=0.123      P=0.162      P=0.393N   |  P=0.450N     P=0.500N     P=0.478      P=0.531N   |
|LOGISTIC REGRESSION    |  P=0.464N     P=0.134      P=0.226      P=0.527N   |  P=0.442N     P=0.503N     P=0.486      P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.263N                                          |  P=0.460N                                          |
|FISHER EXACT           |               P=0.118      P=0.263      P=0.500N   |               P=0.500N     P=0.508      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/54 (2%)    1/54 (2%)    1/54 (2%)    2/54 (4%)  |  1/50 (2%)    0/50 (0%)    0/51 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.2%         2.0%         2.9%         6.2%      |   2.7%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    0/32 (0%)    0/23 (0%)  |  0/33 (0%)    0/30 (0%)    0/30 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   350          514          667          595       |   696          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.298      P=0.729N     P=0.746N     P=0.456    |  P=0.305N     P=0.517N     P=0.523N     P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.422      P=0.607      P=0.689      P=0.540    |  P=0.322N     P=0.500N     P=0.500N     P=0.531N   |
|LOGISTIC REGRESSION    |  P=0.373      P=0.668      P=0.760      P=0.508    |  P=0.304N     P=0.503N     P=0.502N     P=0.499N   |
|COCHRAN-ARMITAGE       |  P=0.351                                           |  P=0.305N                                          |
|FISHER EXACT           |               P=0.752N     P=0.752N     P=0.500    |               P=0.500N     P=0.495N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/54 (4%)    0/53 (0%)    1/53 (2%)    0/53 (0%)  |  0/49 (0%)    0/29 (0%)    1/28 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.9%         0.0%         3.1%         0.0%      |   0.0%         0.0%        12.5%         0.0%      |
|TERMINAL (d)           |  2/29 (7%)    0/32 (0%)    1/32 (3%)    0/23 (0%)  |  0/33 (0%)    0/9 (0%)     1/8 (13%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          731 (T)      ---       |   ---          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.217N     P=0.216N     P=0.465N     P=0.290N   |  P=0.706        (e)        P=0.221        (e)      |
|INCIDENTAL TUMOR       |  P=0.217N     P=0.216N     P=0.465N     P=0.290N   |  P=0.706        (e)        P=0.221        (e)      |
|LOGISTIC REGRESSION    |  P=0.217N     P=0.216N     P=0.465N     P=0.290N   |  P=0.706        (e)        P=0.221        (e)      |
|COCHRAN-ARMITAGE       |  P=0.191N                                          |  P=0.693                                           |
|FISHER EXACT           |               P=0.252N     P=0.507N     P=0.252N   |                 (e)        P=0.364        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/53 (0%)    0/53 (0%)    1/54 (2%)    0/53 (0%)  |  1/49 (2%)    1/50 (2%)    1/51 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   0.0%         0.0%         3.1%         0.0%      |   3.0%         2.6%         3.3%         8.1%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    1/32 (3%)    0/23 (0%)  |  1/33 (3%)    0/30 (0%)    1/30 (3%)    3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          731 (T)      ---       |   731 (T)      644          731 (T)      731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.673        (e)        P=0.520        (e)      |  P=0.205      P=0.744      P=0.741      P=0.346    |
|INCIDENTAL TUMOR       |  P=0.673        (e)        P=0.520        (e)      |  P=0.165      P=0.735N     P=0.741      P=0.346    |
|LOGISTIC REGRESSION    |  P=0.673        (e)        P=0.520        (e)      |  P=0.182      P=0.759N     P=0.741      P=0.346    |
|COCHRAN-ARMITAGE       |  P=0.695                                           |  P=0.167                                           |
|FISHER EXACT           |                 (e)        P=0.505        (e)      |               P=0.747N     P=0.742N     P=0.316    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/53 (2%)    0/53 (0%)    1/54 (2%)    1/53 (2%)  |  1/49 (2%)    1/50 (2%)    1/51 (2%)    3/50 (6%)  |
|ADJUSTED (b)           |   3.4%         0.0%         3.1%         4.3%      |   3.0%         2.6%         3.3%         8.1%      |
|TERMINAL (d)           |  1/29 (3%)    0/32 (0%)    1/32 (3%)    1/23 (4%)  |  1/33 (3%)    0/30 (0%)    1/30 (3%)    3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          731 (T)      731 (T)   |   731 (T)      644          731 (T)      731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.477      P=0.480N     P=0.740N     P=0.710    |  P=0.205      P=0.744      P=0.741      P=0.346    |
|INCIDENTAL TUMOR       |  P=0.477      P=0.480N     P=0.740N     P=0.710    |  P=0.165      P=0.735N     P=0.741      P=0.346    |
|LOGISTIC REGRESSION    |  P=0.477      P=0.480N     P=0.740N     P=0.710    |  P=0.182      P=0.759N     P=0.741      P=0.346    |
|COCHRAN-ARMITAGE       |  P=0.540                                           |  P=0.167                                           |
|FISHER EXACT           |               P=0.500N     P=0.748N     P=0.752N   |               P=0.747N     P=0.742N     P=0.316    |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/50 (6%)    3/50 (6%)    1/51 (2%)    1/50 (2%)  |
|ADJUSTED (b)           |                                                    |   8.4%         8.7%         3.2%         2.7%      |
|TERMINAL (d)           |                                                    |  2/33 (6%)    2/30 (7%)    0/30 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   655          539          730          731 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.144N     P=0.626      P=0.337N     P=0.270N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.156N     P=0.646      P=0.321N     P=0.290N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.160N     P=0.662      P=0.316N     P=0.292N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.163N                                          |
|FISHER EXACT           |                                                    |               P=0.661N     P=0.301N     P=0.309N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/54 (6%)    0/54 (0%)    1/54 (2%)    0/54 (0%)  |  0/50 (0%)    0/50 (0%)    1/51 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  10.3%         0.0%         3.1%         0.0%      |   0.0%         0.0%         3.3%         0.0%      |
|TERMINAL (d)           |  3/29 (10%)   0/32 (0%)    1/32 (3%)    0/23 (0%)  |  0/33 (0%)    0/30 (0%)    1/30 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          731 (T)      ---       |   ---          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.102N     P=0.103N     P=0.269N     P=0.163N   |  P=0.706        (e)        P=0.481        (e)      |
|INCIDENTAL TUMOR       |  P=0.102N     P=0.103N     P=0.269N     P=0.163N   |  P=0.706        (e)        P=0.481        (e)      |
|LOGISTIC REGRESSION    |  P=0.102N     P=0.103N     P=0.269N     P=0.163N   |  P=0.706        (e)        P=0.481        (e)      |
|COCHRAN-ARMITAGE       |  P=0.086N                                          |  P=0.695                                           |
|FISHER EXACT           |               P=0.121N     P=0.309N     P=0.121N   |                 (e)        P=0.505        (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/54 (6%)    0/54 (0%)    1/54 (2%)    1/54 (2%)  |  0/50 (0%)    0/50 (0%)    1/51 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  10.3%         0.0%         3.1%         4.3%      |   0.0%         0.0%         3.3%         0.0%      |
|TERMINAL (d)           |  3/29 (10%)   0/32 (0%)    1/32 (3%)    1/23 (4%)  |  0/33 (0%)    0/30 (0%)    1/30 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   731 (T)      ---          731 (T)      731 (T)   |   ---          ---          731 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.359N     P=0.103N     P=0.269N     P=0.390N   |  P=0.706        (e)        P=0.481        (e)      |
|INCIDENTAL TUMOR       |  P=0.359N     P=0.103N     P=0.269N     P=0.390N   |  P=0.706        (e)        P=0.481        (e)      |
|LOGISTIC REGRESSION    |  P=0.359N     P=0.103N     P=0.269N     P=0.390N   |  P=0.706        (e)        P=0.481        (e)      |
|COCHRAN-ARMITAGE       |  P=0.296N                                          |  P=0.695                                           |
|FISHER EXACT           |               P=0.121N     P=0.309N     P=0.309N   |                 (e)        P=0.505        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/54 (4%)    0/54 (0%)    0/54 (0%)    0/54 (0%)  |  0/50 (0%)    0/50 (0%)    0/51 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.8%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/29 (0%)    0/32 (0%)    0/32 (0%)    0/23 (0%)  |  0/33 (0%)    0/30 (0%)    0/30 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   630          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.120N     P=0.207N     P=0.227N     P=0.256N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.122N     P=0.176N     P=0.282N     P=0.252N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.118N     P=0.225N     P=0.234N     P=0.257N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.115N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  8/54 (15%)   3/54 (6%)    5/54 (9%)    8/54 (15%) | 17/50 (34%)  13/50 (26%)   9/51 (18%)   7/50 (14%) |
|ADJUSTED (b)           |  23.8%         7.4%        15.6%        29.4%      |  42.5%        35.2%        23.9%        16.5%      |
|TERMINAL (d)           |  4/29 (14%)   1/32 (3%)    5/32 (16%)   5/23 (22%) | 11/33 (33%)   8/30 (27%)   4/30 (13%)   3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   630          578          731 (T)      597       |   520          476          612          500       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.239      P=0.076N     P=0.229N     P=0.460    |  P=0.008N**   P=0.354N     P=0.101N     P=0.015N*  |
|INCIDENTAL TUMOR       |  P=0.215      P=0.053N     P=0.270N     P=0.489    |  P=0.014N*    P=0.273N     P=0.049N*    P=0.023N*  |
|LOGISTIC REGRESSION    |  P=0.260      P=0.070N     P=0.238N     P=0.497    |  P=0.010N**   P=0.256N     P=0.054N     P=0.018N*  |
|COCHRAN-ARMITAGE       |  P=0.385                                           |  P=0.010N**                                        |
|FISHER EXACT           |               P=0.101N     P=0.278N     P=0.606N   |               P=0.257N     P=0.049N*    P=0.017N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/54 (11%)   3/54 (6%)    5/54 (9%)    8/54 (15%) | 17/50 (34%)  13/50 (26%)   9/51 (18%)   7/50 (14%) |
|ADJUSTED (b)           |  19.0%         7.4%        15.6%        29.4%      |  42.5%        35.2%        23.9%        16.5%      |
|TERMINAL (d)           |  4/29 (14%)   1/32 (3%)    5/32 (16%)   5/23 (22%) | 11/33 (33%)   8/30 (27%)   4/30 (13%)   3/37 (8%)  |
|FIRST INCIDENCE (DAYS) |   637          578          731 (T)      597       |   520          476          612          500       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.100      P=0.195N     P=0.438N     P=0.257    |  P=0.008N**   P=0.354N     P=0.101N     P=0.015N*  |
|INCIDENTAL TUMOR       |  P=0.086      P=0.174N     P=0.468N     P=0.278    |  P=0.014N*    P=0.273N     P=0.049N*    P=0.023N*  |
|LOGISTIC REGRESSION    |  P=0.113      P=0.186N     P=0.448N     P=0.286    |  P=0.010N**   P=0.256N     P=0.054N     P=0.018N*  |
|COCHRAN-ARMITAGE       |  P=0.201                                           |  P=0.010N**                                        |
|FISHER EXACT           |               P=0.244N     P=0.500N     P=0.388    |               P=0.257N     P=0.049N*    P=0.017N*  |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/54 (31%)  11/54 (20%)  13/54 (24%)  19/54 (35%) | 29/50 (58%)  19/50 (38%)  19/51 (37%)  26/50 (52%) |
|ADJUSTED (b)           |  54.3%        32.7%        40.6%        69.2%      |  72.4%        47.7%        47.5%        64.7%      |
|TERMINAL (d)           | 15/29 (52%)  10/32 (31%)  13/32 (41%)  15/23 (65%) | 22/33 (67%)  10/30 (33%)  10/30 (33%)  23/37 (62%) |
|FIRST INCIDENCE (DAYS) |   469          599          731 (T)      317       |   578          472          500          469       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.042 *    P=0.062N     P=0.144N     P=0.135    |  P=0.272N     P=0.105N     P=0.101N     P=0.172N   |
|INCIDENTAL TUMOR       |  P=0.060      P=0.066N     P=0.142N     P=0.195    |  P=0.459N     P=0.042N*    P=0.039N*    P=0.275N   |
|LOGISTIC REGRESSION    |  P=0.075      P=0.049N*    P=0.171N     P=0.225    |  P=0.420N     P=0.041N*    P=0.041N*    P=0.254N   |
|COCHRAN-ARMITAGE       |  P=0.236                                           |  P=0.467N                                          |
|FISHER EXACT           |               P=0.136N     P=0.260N     P=0.419    |               P=0.036N*    P=0.029N*    P=0.344N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/54 (41%)  28/54 (52%)  23/54 (43%)  20/54 (37%) | 21/50 (42%)  21/50 (42%)  22/51 (43%)  17/50 (34%) |
|ADJUSTED (b)           |  52.1%        57.8%        53.5%        54.9%      |  49.4%        53.0%        52.6%        37.5%      |
|TERMINAL (d)           |  9/29 (31%)  12/32 (38%)  12/32 (38%)   7/23 (30%) | 12/33 (36%)  12/30 (40%)  11/30 (37%)   9/37 (24%) |
|FIRST INCIDENCE (DAYS) |   350          514          517          498       |   520          476          367          500       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.498      P=0.401      P=0.517N     P=0.477    |  P=0.150N     P=0.457      P=0.400      P=0.202N   |
|INCIDENTAL TUMOR       |  P=0.519N     P=0.388      P=0.435      P=0.588N   |  P=0.268N     P=0.548      P=0.522      P=0.325N   |
|LOGISTIC REGRESSION    |  P=0.419      P=0.376      P=0.449      P=0.410    |  P=0.219N     P=0.568      P=0.520      P=0.418N   |
|COCHRAN-ARMITAGE       |  P=0.236N                                          |  P=0.222N                                          |
|FISHER EXACT           |               P=0.167      P=0.500      P=0.422N   |               P=0.580N     P=0.534      P=0.268N   |
|=================================================================================================================================|
 
         DATE: 09/04/94                     EXPERIMENT: 05025 TEST: 01                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- ETHYLENE GLYCOL
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.625%       1.25%        2.5%      |   UNTREATD     1.25%        2.5%         5.0%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/54 (63%)  36/54 (67%)  31/54 (57%)  33/54 (61%) | 39/50 (78%)  33/50 (66%)  31/51 (61%)  36/50 (72%) |
|ADJUSTED (b)           |  79.0%        73.3%        72.1%        86.6%      |  86.6%        74.7%        71.6%        75.0%      |
|TERMINAL (d)           | 20/29 (69%)  19/32 (59%)  20/32 (63%)  18/23 (78%) | 27/33 (82%)  19/30 (63%)  18/30 (60%)  25/37 (68%) |
|FIRST INCIDENCE (DAYS) |   350          514          517          317       |   520          472          367          457       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.229      P=0.416N     P=0.226N     P=0.254    |  P=0.179N     P=0.361N     P=0.237N     P=0.178N   |
|INCIDENTAL TUMOR       |  P=0.189      P=0.361N     P=0.283N     P=0.269    |  P=0.377N     P=0.157N     P=0.067N     P=0.332N   |
|LOGISTIC REGRESSION    |  P=0.107      P=0.324N     P=0.283N     P=0.148    |  P=0.342N     P=0.149N     P=0.070N     P=0.304N   |
|COCHRAN-ARMITAGE       |  P=0.370N                                          |  P=0.362N                                          |
|FISHER EXACT           |               P=0.420      P=0.347N     P=0.500N   |               P=0.133N     P=0.048N*    P=0.322N   |
|=================================================================================================================================|
 
 (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).