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TDMS Study 05109-12 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/20/95       
EXPERIMENT: 05109 TEST: 12                                                                                     TIME: 00:27:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: R. PERSING                      S. GRUMBEIN                                                       CAS: 102-71-6        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/20/95       
EXPERIMENT: 05109 TEST: 12                                                                                     TIME: 00:27:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: R. PERSING                      S. GRUMBEIN                                                       CAS: 102-71-6        


                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    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: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/20/95       
EXPERIMENT: 05109 TEST: 12                                                                                     TIME: 00:27:05       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: R. PERSING                      S. GRUMBEIN                                                       CAS: 102-71-6        


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF TRIETHANOLAMINE
              ====================================================================================================
                                                           MALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Liver                         Hepatoblastoma
                                            Hepatocellular Adenoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              All Organs                    Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
                                                           FEMALE MICE
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Bone                          Osteosarcoma
              Liver                         Hepatocellular Adenoma
                                            Hepatocellular Carcinoma
                                            Hepatocellular Carcinoma or Hepatoblastoma
                                            Hepatocellular Carcinoma or Hepatocellular Adenoma
                                            Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
              Ovary                         Cystadenoma
              All Organs                    Hemangiosarcoma
                                            Hemangiosarcoma or Hemangioma
                                            Malignant Lymphoma And Histiocytic Sarcoma
                                            Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
                                             Cell Type
                                            Benign Tumors
                                            Malignant Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         4.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    0/41 (0%)  |  0/39 (0%)    0/40 (0%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          ---          551       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.043 *      (e)          (e)        P=0.250    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.057        (e)          (e)        P=0.420    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.039 *      (e)          (e)        P=0.225    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.042 *                                         |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    5/60 (8%)    5/60 (8%)    1/60 (2%)  |  1/60 (2%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   8.7%        12.5%        12.4%         2.1%      |   2.6%         2.5%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/46 (9%)    5/40 (13%)   4/39 (10%)   0/41 (0%)  |  1/39 (3%)    1/40 (3%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      694          606       |   729 (T)      729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.113N     P=0.413      P=0.400      P=0.212N   |  P=0.342N     P=0.756N     P=0.756      P=0.510N   |
|INCIDENTAL TUMOR       |  P=0.082N     P=0.413      P=0.478      P=0.145N   |  P=0.342N     P=0.756N     P=0.756      P=0.510N   |
|LOGISTIC REGRESSION    |  P=0.100N     P=0.413      P=0.425      P=0.185N   |  P=0.342N     P=0.756N     P=0.756      P=0.510N   |
|COCHRAN-ARMITAGE       |  P=0.097N                                          |  P=0.328N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.182N   |               P=0.752N     P=0.752N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%         0.0%         0.0%         4.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/46 (2%)    0/40 (0%)    0/39 (0%)    2/41 (5%)  |  0/39 (0%)    0/40 (0%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.177      P=0.528N     P=0.533N     P=0.460    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.177      P=0.528N     P=0.533N     P=0.460    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.177      P=0.528N     P=0.533N     P=0.460    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.186                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    3/60 (5%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    3/60 (5%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.3%         7.5%         2.6%         2.4%      |   0.0%         7.5%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/46 (4%)    3/40 (8%)    1/39 (3%)    1/41 (2%)  |  0/39 (0%)    3/40 (8%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.333N     P=0.436      P=0.558N     P=0.540N   |  P=0.289N     P=0.126        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.333N     P=0.436      P=0.558N     P=0.540N   |  P=0.289N     P=0.126        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.333N     P=0.436      P=0.558N     P=0.540N   |  P=0.289N     P=0.126        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.312N                                          |  P=0.276N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.500N   |               P=0.122        (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    3/60 (5%)  |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         7.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    2/41 (5%)  |  0/39 (0%)    0/40 (0%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          675       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **     (e)          (e)        P=0.106    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.010 *      (e)          (e)        P=0.164    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.009 **     (e)          (e)        P=0.117    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.009 **                                        |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.122    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 28/60 (47%)  29/60 (48%)  30/60 (50%)  41/60 (68%) | 24/60 (40%)  24/60 (40%)  25/60 (42%)  41/60 (68%) |
|ADJUSTED (b)           |  54.6%        63.9%        67.9%        80.1%      |  56.6%        55.2%        59.0%        95.3%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   1/10 (10%)   4/10 (40%) |  2/10 (20%)   2/10 (20%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           | 23/46 (50%)  24/40 (60%)  25/39 (64%)  31/41 (76%) | 21/39 (54%)  21/40 (53%)  21/38 (55%)  35/37 (95%) |
|FIRST INCIDENCE (DAYS) |   367          456 (I)      456 (I)      456 (I)   |   457 (I)      457 (I)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.003 **   P=0.265      P=0.165      P=0.005 ** |  P<0.001 **   P=0.534N     P=0.462      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.006 **   P=0.487      P=0.356      P=0.012 *  |  P<0.001 **   P=0.497N     P=0.568N     P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.003 **   P=0.460      P=0.307      P=0.010 *  |  P<0.001 **   P=0.476N     P=0.579N     P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500      P=0.428      P=0.013 *  |               P=0.574N     P=0.500      P=0.002 ** |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/60 (27%)  22/60 (37%)  15/60 (25%)  15/60 (25%) |  1/60 (2%)    4/60 (7%)    7/60 (12%)   5/60 (8%)  |
|ADJUSTED (b)           |  32.4%        44.9%        33.2%        31.2%      |   2.6%         9.0%        15.7%        12.8%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 13/46 (28%)  14/40 (35%)   9/39 (23%)   9/41 (22%) |  1/39 (3%)    2/40 (5%)    4/38 (11%)   4/37 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      507          456 (I)   |   729 (T)      557          434          591       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.327N     P=0.095      P=0.477      P=0.543    |  P=0.203      P=0.201      P=0.038 *    P=0.098    |
|INCIDENTAL TUMOR       |  P=0.154N     P=0.259      P=0.346N     P=0.313N   |  P=0.211      P=0.314      P=0.031 *    P=0.119    |
|LOGISTIC REGRESSION    |  P=0.169N     P=0.286      P=0.374N     P=0.347N   |  P=0.270      P=0.189      P=0.034 *    P=0.109    |
|COCHRAN-ARMITAGE       |  P=0.260N                                          |  P=0.220                                           |
|FISHER EXACT           |               P=0.163      P=0.500N     P=0.500N   |               P=0.182      P=0.031 *    P=0.103    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/60 (27%)  22/60 (37%)  15/60 (25%)  17/60 (28%) |  1/60 (2%)    4/60 (7%)    7/60 (12%)   5/60 (8%)  |
|ADJUSTED (b)           |  32.4%        44.9%        33.2%        35.5%      |   2.6%         9.0%        15.7%        12.8%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 13/46 (28%)  14/40 (35%)   9/39 (23%)  11/41 (27%) |  1/39 (3%)    2/40 (5%)    4/38 (11%)   4/37 (11%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      507          456 (I)   |   729 (T)      557          434          591       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.500N     P=0.095      P=0.477      P=0.380    |  P=0.203      P=0.201      P=0.038 *    P=0.098    |
|INCIDENTAL TUMOR       |  P=0.306N     P=0.259      P=0.346N     P=0.490N   |  P=0.211      P=0.314      P=0.031 *    P=0.119    |
|LOGISTIC REGRESSION    |  P=0.328N     P=0.286      P=0.374N     P=0.526N   |  P=0.270      P=0.189      P=0.034 *    P=0.109    |
|COCHRAN-ARMITAGE       |  P=0.435N                                          |  P=0.220                                           |
|FISHER EXACT           |               P=0.163      P=0.500N     P=0.500    |               P=0.182      P=0.031 *    P=0.103    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/60 (55%)  38/60 (63%)  34/60 (57%)  47/60 (78%) | 25/60 (42%)  28/60 (47%)  29/60 (48%)  42/60 (70%) |
|ADJUSTED (b)           |  63.2%        74.1%        73.7%        86.9%      |  59.0%        61.6%        65.2%        95.4%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   1/10 (10%)   5/10 (50%) |  2/10 (20%)   2/10 (20%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           | 27/46 (59%)  27/40 (68%)  27/39 (69%)  34/41 (83%) | 22/39 (56%)  23/40 (58%)  23/38 (61%)  35/37 (95%) |
|FIRST INCIDENCE (DAYS) |   367          456 (I)      456 (I)      456 (I)   |   457 (I)      457 (I)      434          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005 **   P=0.089      P=0.191      P=0.002 ** |  P<0.001 **   P=0.402      P=0.256      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.007 **   P=0.267      P=0.480      P=0.007 ** |  P<0.001 **   P=0.505      P=0.326      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.004 **   P=0.207      P=0.384      P=0.005 ** |  P<0.001 **   P=0.454      P=0.357      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.229      P=0.500      P=0.006 ** |               P=0.357      P=0.291      P=0.002 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 33/60 (55%)  38/60 (63%)  34/60 (57%)  47/60 (78%) | 25/60 (42%)  28/60 (47%)  29/60 (48%)  42/60 (70%) |
|ADJUSTED (b)           |  63.2%        74.1%        73.7%        86.9%      |  59.0%        61.6%        65.2%        95.4%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   1/10 (10%)   5/10 (50%) |  2/10 (20%)   2/10 (20%)   1/10 (10%)   1/10 (10%) |
|TERMINAL (d)           | 27/46 (59%)  27/40 (68%)  27/39 (69%)  34/41 (83%) | 22/39 (56%)  23/40 (58%)  23/38 (61%)  35/37 (95%) |
|FIRST INCIDENCE (DAYS) |   367          456 (I)      456 (I)      456 (I)   |   457 (I)      457 (I)      434          457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005 **   P=0.089      P=0.191      P=0.002 ** |  P<0.001 **   P=0.402      P=0.256      P<0.001 ** |
|INCIDENTAL TUMOR       |  P=0.007 **   P=0.267      P=0.480      P=0.007 ** |  P<0.001 **   P=0.505      P=0.326      P<0.001 ** |
|LOGISTIC REGRESSION    |  P=0.004 **   P=0.207      P=0.384      P=0.005 ** |  P<0.001 **   P=0.454      P=0.357      P<0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.005 **                                        |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.229      P=0.500      P=0.006 ** |               P=0.357      P=0.291      P=0.002 ** |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 15/60 (25%)  15/60 (25%)  14/60 (23%)  10/60 (17%) |  2/60 (3%)    5/60 (8%)    2/60 (3%)    5/59 (8%)  |
|ADJUSTED (b)           |  32.6%        36.4%        35.9%        23.7%      |   5.1%        11.6%         5.3%        13.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 15/46 (33%)  14/40 (35%)  14/39 (36%)   9/41 (22%) |  2/39 (5%)    4/40 (10%)   2/38 (5%)    4/36 (11%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      621          729 (T)      675       |   729 (T)      457 (I)      729 (T)      521       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.160N     P=0.410      P=0.465      P=0.274N   |  P=0.234      P=0.227      P=0.686      P=0.196    |
|INCIDENTAL TUMOR       |  P=0.134N     P=0.410      P=0.465      P=0.233N   |  P=0.248      P=0.227      P=0.686      P=0.191    |
|LOGISTIC REGRESSION    |  P=0.137N     P=0.489      P=0.465      P=0.228N   |  P=0.266      P=0.234      P=0.686      P=0.219    |
|COCHRAN-ARMITAGE       |  P=0.130N                                          |  P=0.265                                           |
|FISHER EXACT           |               P=0.583N     P=0.500N     P=0.184N   |               P=0.219      P=0.691N     P=0.213    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    5/60 (8%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/59 (3%)  |
|ADJUSTED (b)           |   4.3%        11.7%         2.4%         2.0%      |   0.0%         0.0%         2.6%         4.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/46 (4%)    3/40 (8%)    0/39 (0%)    0/41 (0%)  |  0/39 (0%)    0/40 (0%)    1/38 (3%)    1/36 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      666          677          579       |   ---          ---          729 (T)      415       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.210N     P=0.175      P=0.553N     P=0.527N   |  P=0.084        (e)        P=0.495      P=0.237    |
|INCIDENTAL TUMOR       |  P=0.125N     P=0.306      P=0.419N     P=0.408N   |  P=0.105        (e)        P=0.495      P=0.231    |
|LOGISTIC REGRESSION    |  P=0.139N     P=0.201      P=0.526N     P=0.501N   |  P=0.085        (e)        P=0.495      P=0.207    |
|COCHRAN-ARMITAGE       |  P=0.192N                                          |  P=0.088                                           |
|FISHER EXACT           |               P=0.219      P=0.500N     P=0.500N   |                 (e)        P=0.500      P=0.244    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 16/60 (27%)  19/60 (32%)  15/60 (25%)  11/60 (18%) |  2/60 (3%)    5/60 (8%)    3/60 (5%)    7/59 (12%) |
|ADJUSTED (b)           |  34.8%        43.9%        37.4%        25.2%      |   5.1%        11.6%         7.9%        17.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    1/10 (10%)   0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 16/46 (35%)  16/40 (40%)  14/39 (36%)   9/41 (22%) |  2/39 (5%)    4/40 (10%)   3/38 (8%)    5/36 (14%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      621          677          579       |   729 (T)      457 (I)      729 (T)      415       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.113N     P=0.186      P=0.453      P=0.286N   |  P=0.068      P=0.227      P=0.488      P=0.073    |
|INCIDENTAL TUMOR       |  P=0.069N     P=0.255      P=0.503      P=0.210N   |  P=0.079      P=0.227      P=0.488      P=0.065    |
|LOGISTIC REGRESSION    |  P=0.086N     P=0.259      P=0.487      P=0.217N   |  P=0.084      P=0.234      P=0.488      P=0.083    |
|COCHRAN-ARMITAGE       |  P=0.086N                                          |  P=0.083                                           |
|FISHER EXACT           |               P=0.344      P=0.500N     P=0.191N   |               P=0.219      P=0.500      P=0.077    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  5/59 (8%)    0/60 (0%)    4/59 (7%)    2/60 (3%)  |
|ADJUSTED (b)           |                                                    |  12.3%         0.0%        10.5%         5.4%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  4/39 (10%)   0/40 (0%)    4/38 (11%)   2/37 (5%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   572          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.435N     P=0.031N*    P=0.508N     P=0.234N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.435N     P=0.017N*    P=0.430N     P=0.196N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.406N     P=0.029N*    P=0.479N     P=0.204N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.401N                                          |
|FISHER EXACT           |                                                    |               P=0.027N*    P=0.500N     P=0.213N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Luteoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/59 (5%)    2/60 (3%)    0/59 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |                                                    |   7.7%         5.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/9 (0%)     0/10 (0%)    0/9 (0%)     0/10 (0%)  |
|TERMINAL (d)           |                                                    |  3/39 (8%)    2/40 (5%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.088N     P=0.488N     P=0.126N     P=0.130N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.088N     P=0.488N     P=0.126N     P=0.130N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.088N     P=0.488N     P=0.126N     P=0.130N   |
|COCHRAN-ARMITAGE       |                                                    |  P=0.081N                                          |
|FISHER EXACT           |                                                    |               P=0.492N     P=0.122N     P=0.119N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/58 (0%)    0/59 (0%)    0/56 (0%)    0/59 (0%)  |  4/54 (7%)    6/59 (10%)   4/59 (7%)    5/59 (8%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |  10.1%        15.4%        10.8%        12.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/45 (0%)    0/39 (0%)    0/38 (0%)    0/40 (0%)  |  2/34 (6%)    6/39 (15%)   4/37 (11%)   4/37 (11%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   487          729 (T)      729 (T)      647       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.563      P=0.444      P=0.606N     P=0.537    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.543N     P=0.407      P=0.601N     P=0.631N   |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.574N     P=0.462      P=0.572N     P=0.578    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.583                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.429      P=0.591N     P=0.556    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/58 (0%)    0/59 (0%)    0/56 (0%)    0/59 (0%)  |  0/54 (0%)    1/59 (2%)    0/59 (0%)    2/59 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         2.6%         0.0%         5.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/45 (0%)    0/39 (0%)    0/38 (0%)    0/40 (0%)  |  0/34 (0%)    1/39 (3%)    0/37 (0%)    1/37 (3%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          729 (T)      ---          670       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.151      P=0.527        (e)        P=0.249    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.195      P=0.527        (e)        P=0.340    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.160      P=0.527        (e)        P=0.267    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.157                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=0.522        (e)        P=0.270    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    3/60 (5%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.4%      |   2.4%         7.0%         4.8%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  0/39 (0%)    2/40 (5%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   698          578          603          680       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.216        (e)          (e)        P=0.477    |  P=0.435N     P=0.322      P=0.502      P=0.755    |
|INCIDENTAL TUMOR       |  P=0.216        (e)          (e)        P=0.477    |  P=0.354N     P=0.453      P=0.699      P=0.565N   |
|LOGISTIC REGRESSION    |  P=0.216        (e)          (e)        P=0.477    |  P=0.337N     P=0.318      P=0.510      P=0.756N   |
|COCHRAN-ARMITAGE       |  P=0.221                                           |  P=0.422N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.309      P=0.500      P=0.752N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    3/60 (5%)    2/60 (3%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.4%      |   2.4%         7.0%         4.8%         2.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  0/39 (0%)    2/40 (5%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   698          578          603          680       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.216        (e)          (e)        P=0.477    |  P=0.435N     P=0.322      P=0.502      P=0.755    |
|INCIDENTAL TUMOR       |  P=0.216        (e)          (e)        P=0.477    |  P=0.354N     P=0.453      P=0.699      P=0.565N   |
|LOGISTIC REGRESSION    |  P=0.216        (e)          (e)        P=0.477    |  P=0.337N     P=0.318      P=0.510      P=0.756N   |
|COCHRAN-ARMITAGE       |  P=0.221                                           |  P=0.422N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.309      P=0.500      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  1/60 (2%)    3/60 (5%)    2/60 (3%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.4%      |   2.4%         7.0%         4.8%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  0/39 (0%)    2/40 (5%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          729 (T)   |   698          578          603          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.216        (e)          (e)        P=0.477    |  P=0.193N     P=0.322      P=0.502      P=0.505N   |
|INCIDENTAL TUMOR       |  P=0.216        (e)          (e)        P=0.477    |  P=0.155N     P=0.453      P=0.699      P=0.331N   |
|LOGISTIC REGRESSION    |  P=0.216        (e)          (e)        P=0.477    |  P=0.135N     P=0.318      P=0.510      P=0.495N   |
|COCHRAN-ARMITAGE       |  P=0.221                                           |  P=0.184N                                          |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=0.309      P=0.500      P=0.500N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  3/60 (5%)    1/60 (2%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%         0.0%         0.0%         2.4%      |   7.7%         2.5%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/46 (2%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  3/39 (8%)    1/40 (3%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          729 (T)   |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.524      P=0.528N     P=0.533N     P=0.736    |  P=0.117N     P=0.296N     P=0.126N     P=0.130N   |
|INCIDENTAL TUMOR       |  P=0.524      P=0.528N     P=0.533N     P=0.736    |  P=0.117N     P=0.296N     P=0.126N     P=0.130N   |
|LOGISTIC REGRESSION    |  P=0.524      P=0.528N     P=0.533N     P=0.736    |  P=0.117N     P=0.296N     P=0.126N     P=0.130N   |
|COCHRAN-ARMITAGE       |  P=0.536                                           |  P=0.110N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.752N   |               P=0.309N     P=0.122N     P=0.122N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/60 (3%)    0/60 (0%)    0/60 (0%)  |                                                    |
|ADJUSTED (b)           |   0.0%         5.0%         0.0%         0.0%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |                                                    |
|TERMINAL (d)           |  0/46 (0%)    2/40 (5%)    0/39 (0%)    0/41 (0%)  |                                                    |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.405N     P=0.208        (e)          (e)      |                                                    |
|INCIDENTAL TUMOR       |  P=0.405N     P=0.208        (e)          (e)      |                                                    |
|LOGISTIC REGRESSION    |  P=0.405N     P=0.208        (e)          (e)      |                                                    |
|COCHRAN-ARMITAGE       |  P=0.393N                                          |                                                    |
|FISHER EXACT           |               P=0.248        (e)          (e)      |                                                    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  4/60 (7%)    2/60 (3%)    5/60 (8%)    6/60 (10%) |
|ADJUSTED (b)           |   4.3%         0.0%         0.0%         2.4%      |  10.3%         5.0%        13.2%        16.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/46 (4%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  4/39 (10%)   2/40 (5%)    5/38 (13%)   6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          729 (T)   |   729 (T)      729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.150      P=0.325N     P=0.484      P=0.335    |
|INCIDENTAL TUMOR       |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.150      P=0.325N     P=0.484      P=0.335    |
|LOGISTIC REGRESSION    |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.150      P=0.325N     P=0.484      P=0.335    |
|COCHRAN-ARMITAGE       |  P=0.672N                                          |  P=0.184                                           |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |               P=0.340N     P=0.500      P=0.372    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/60 (0%)    0/60 (0%)    1/60 (2%)  |  4/60 (7%)    2/60 (3%)    6/60 (10%)   6/60 (10%) |
|ADJUSTED (b)           |   4.3%         0.0%         0.0%         2.4%      |  10.3%         5.0%        15.8%        16.2%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/46 (4%)    0/40 (0%)    0/39 (0%)    1/41 (2%)  |  4/39 (10%)   2/40 (5%)    6/38 (16%)   6/37 (16%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          729 (T)   |   729 (T)      729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.162      P=0.325N     P=0.352      P=0.335    |
|INCIDENTAL TUMOR       |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.162      P=0.325N     P=0.352      P=0.335    |
|LOGISTIC REGRESSION    |  P=0.685N     P=0.270N     P=0.276N     P=0.540N   |  P=0.162      P=0.325N     P=0.352      P=0.335    |
|COCHRAN-ARMITAGE       |  P=0.672N                                          |  P=0.198                                           |
|FISHER EXACT           |               P=0.248N     P=0.248N     P=0.500N   |               P=0.340N     P=0.372      P=0.372    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  1/60 (2%)    1/60 (2%)    1/60 (2%)    3/60 (5%)  |
|ADJUSTED (b)           |                                                    |   2.6%         2.5%         1.7%         5.9%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/10 (0%)    0/10 (0%)    1/10 (10%)   2/10 (20%) |
|TERMINAL (d)           |                                                    |  1/39 (3%)    1/40 (3%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |                                                    |   729 (T)      729 (T)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.150      P=0.756N     P=0.757      P=0.301    |
|INCIDENTAL TUMOR       |                                                    |  P=0.180      P=0.756N     P=0.757      P=0.373    |
|LOGISTIC REGRESSION    |                                                    |  P=0.140      P=0.756N     P=0.747      P=0.275    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.157                                           |
|FISHER EXACT           |                                                    |               P=0.752N     P=0.752N     P=0.309    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    1/60 (2%)    0/60 (0%)    2/60 (3%)  |  0/60 (0%)    1/60 (2%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   2.2%         2.2%         0.0%         4.9%      |   0.0%         2.5%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  1/46 (2%)    0/40 (0%)    0/39 (0%)    2/41 (5%)  |  0/39 (0%)    1/40 (3%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      667          ---          729 (T)   |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.315      P=0.738      P=0.533N     P=0.460    |  P=0.551N     P=0.505      P=0.495        (e)      |
|INCIDENTAL TUMOR       |  P=0.340      P=0.654N     P=0.533N     P=0.460    |  P=0.551N     P=0.505      P=0.495        (e)      |
|LOGISTIC REGRESSION    |  P=0.324      P=0.758      P=0.533N     P=0.460    |  P=0.551N     P=0.505      P=0.495        (e)      |
|COCHRAN-ARMITAGE       |  P=0.326                                           |  P=0.536N                                          |
|FISHER EXACT           |               P=0.752N     P=0.500N     P=0.500    |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    4/60 (7%)    1/60 (2%)    1/60 (2%)  |  4/60 (7%)    3/60 (5%)    0/60 (0%)    0/60 (0%)  |
|ADJUSTED (b)           |   4.3%        10.0%         2.6%         2.4%      |  10.3%         7.5%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  2/46 (4%)    4/40 (10%)   1/39 (3%)    1/41 (2%)  |  4/39 (10%)   3/40 (8%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      729 (T)      729 (T)   |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.265N     P=0.275      P=0.558N     P=0.540N   |  P=0.042N*    P=0.486N     P=0.066N     P=0.070N   |
|INCIDENTAL TUMOR       |  P=0.265N     P=0.275      P=0.558N     P=0.540N   |  P=0.042N*    P=0.486N     P=0.066N     P=0.070N   |
|LOGISTIC REGRESSION    |  P=0.265N     P=0.275      P=0.558N     P=0.540N   |  P=0.042N*    P=0.486N     P=0.066N     P=0.070N   |
|COCHRAN-ARMITAGE       |  P=0.245N                                          |  P=0.039N*                                         |
|FISHER EXACT           |               P=0.340      P=0.500N     P=0.500N   |               P=0.500N     P=0.059N     P=0.059N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    5/60 (8%)    1/60 (2%)    3/60 (5%)  |  4/60 (7%)    4/60 (7%)    1/60 (2%)    0/60 (0%)  |
|ADJUSTED (b)           |   6.5%        12.0%         2.6%         7.3%      |  10.3%        10.0%         2.6%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  3/46 (7%)    4/40 (10%)   1/39 (3%)    3/41 (7%)  |  4/39 (10%)   4/40 (10%)   1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      667          729 (T)      729 (T)   |   729 (T)      729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.513N     P=0.289      P=0.366N     P=0.609    |  P=0.037N*    P=0.630N     P=0.187N     P=0.070N   |
|INCIDENTAL TUMOR       |  P=0.496N     P=0.364      P=0.366N     P=0.609    |  P=0.037N*    P=0.630N     P=0.187N     P=0.070N   |
|LOGISTIC REGRESSION    |  P=0.496N     P=0.324      P=0.366N     P=0.609    |  P=0.037N*    P=0.630N     P=0.187N     P=0.070N   |
|COCHRAN-ARMITAGE       |  P=0.485N                                          |  P=0.034N*                                         |
|FISHER EXACT           |               P=0.359      P=0.309N     P=0.660N   |               P=0.641N     P=0.182N     P=0.059N   |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    1/60 (2%)    1/60 (2%)  |  0/60 (0%)    2/60 (3%)    2/60 (3%)    3/60 (5%)  |
|ADJUSTED (b)           |   0.0%         0.0%         2.6%         2.3%      |   0.0%         4.2%         4.7%         6.7%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    1/39 (3%)    0/41 (0%)  |  0/39 (0%)    1/40 (3%)    1/38 (3%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          729 (T)      678       |   ---          414          579          521       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.316        (e)        P=0.467      P=0.483    |  P=0.164      P=0.248      P=0.249      P=0.133    |
|INCIDENTAL TUMOR       |  P=0.356        (e)        P=0.467      P=0.718    |  P=0.213      P=0.130      P=0.374      P=0.222    |
|LOGISTIC REGRESSION    |  P=0.325        (e)        P=0.467      P=0.500    |  P=0.152      P=0.221      P=0.240      P=0.111    |
|COCHRAN-ARMITAGE       |  P=0.325                                           |  P=0.163                                           |
|FISHER EXACT           |                 (e)        P=0.500      P=0.500    |               P=0.248      P=0.248      P=0.122    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    1/60 (2%)    9/60 (15%)   2/60 (3%)  |  6/60 (10%)  12/60 (20%)   8/60 (13%)  18/60 (30%) |
|ADJUSTED (b)           |   8.7%         2.5%        22.3%         4.7%      |  15.4%        26.7%        19.5%        41.1%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/46 (9%)    1/40 (3%)    8/39 (21%)   1/41 (2%)  |  6/39 (15%)   8/40 (20%)   6/38 (16%)  12/37 (32%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      645          678       |   729 (T)      414          579          317       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.415N     P=0.224N     P=0.068      P=0.390N   |  P=0.005 **   P=0.117      P=0.379      P=0.005 ** |
|INCIDENTAL TUMOR       |  P=0.385N     P=0.224N     P=0.089      P=0.303N   |  P=0.006 **   P=0.130      P=0.505      P=0.007 ** |
|LOGISTIC REGRESSION    |  P=0.392N     P=0.224N     P=0.080      P=0.355N   |  P=0.006 **   P=0.119      P=0.413      P=0.007 ** |
|COCHRAN-ARMITAGE       |  P=0.383N                                          |  P=0.006 **                                        |
|FISHER EXACT           |               P=0.182N     P=0.120      P=0.340N   |               P=0.100      P=0.389      P=0.006 ** |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated                                               |
|     Cell Type                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/60 (7%)    1/60 (2%)    9/60 (15%)   1/60 (2%)  |  6/60 (10%)  10/60 (17%)   6/60 (10%)  15/60 (25%) |
|ADJUSTED (b)           |   8.7%         2.5%        22.3%         2.4%      |  15.4%        23.1%        15.1%        36.8%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  4/46 (9%)    1/40 (3%)    8/39 (21%)   1/41 (2%)  |  6/39 (15%)   7/40 (18%)   5/38 (13%)  12/37 (32%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      645          729 (T)   |   729 (T)      639          624          317       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.251N     P=0.224N     P=0.068      P=0.216N   |  P=0.013 *    P=0.231      P=0.607      P=0.020 *  |
|INCIDENTAL TUMOR       |  P=0.239N     P=0.224N     P=0.089      P=0.216N   |  P=0.016 *    P=0.308      P=0.568N     P=0.019 *  |
|LOGISTIC REGRESSION    |  P=0.235N     P=0.224N     P=0.080      P=0.216N   |  P=0.018 *    P=0.240      P=0.604N     P=0.029 *  |
|COCHRAN-ARMITAGE       |  P=0.226N                                          |  P=0.020 *                                         |
|FISHER EXACT           |               P=0.182N     P=0.120      P=0.182N   |               P=0.211      P=0.619N     P=0.026 *  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         1.7%         4.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    0/41 (0%)  |  0/39 (0%)    0/40 (0%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          320          551       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.093        (e)        P=0.510      P=0.250    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.068        (e)        P=0.227      P=0.420    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.059        (e)        P=0.290      P=0.225    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.090                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/60 (0%)    0/60 (0%)    0/60 (0%)  |  0/60 (0%)    0/60 (0%)    1/60 (2%)    2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         1.7%         4.4%      |
|INTERIM SACRIFICE 1 (c)|  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           |  0/46 (0%)    0/40 (0%)    0/39 (0%)    0/41 (0%)  |  0/39 (0%)    0/40 (0%)    0/38 (0%)    0/37 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          320          551       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.093        (e)        P=0.510      P=0.250    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.068        (e)        P=0.227      P=0.420    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.059        (e)        P=0.290      P=0.225    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.090                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.500      P=0.248    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 36/60 (60%)  40/60 (67%)  36/60 (60%)  45/60 (75%) | 36/60 (60%)  36/60 (60%)  33/60 (55%)  46/60 (77%) |
|ADJUSTED (b)           |  70.4%        84.9%        81.7%        86.3%      |  79.7%        81.5%        76.3%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   1/10 (10%)   4/10 (40%) |  2/10 (20%)   3/10 (30%)   2/10 (20%)   3/10 (30%) |
|TERMINAL (d)           | 31/46 (67%)  33/40 (83%)  31/39 (79%)  34/41 (83%) | 30/39 (77%)  32/40 (80%)  28/38 (74%)  37/37 (100%)|
|FIRST INCIDENCE (DAYS) |   367          456 (I)      456 (I)      456 (I)   |   457 (I)      457 (I)      457 (I)      457 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.027 *    P=0.073      P=0.189      P=0.016 *  |  P=0.002 **   P=0.510N     P=0.393N     P=0.011 *  |
|INCIDENTAL TUMOR       |  P=0.068      P=0.207      P=0.413      P=0.049 *  |  P=0.004 **   P=0.454N     P=0.221N     P=0.030 *  |
|LOGISTIC REGRESSION    |  P=0.040 *    P=0.218      P=0.404      P=0.045 *  |  P=0.008 **   P=0.410N     P=0.223N     P=0.034 *  |
|COCHRAN-ARMITAGE       |  P=0.059                                           |  P=0.016 *                                         |
|FISHER EXACT           |               P=0.285      P=0.574N     P=0.059    |               P=0.574N     P=0.356N     P=0.038 *  |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0 MG/KG      200          630          2000      |   0 MG/KG      100          300          1000      |
|                       |                MG/KG        MG/KG        MG/KG     |                MG/KG        MG/KG        MG/KG     |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 20/60 (33%)  30/60 (50%)  25/60 (42%)  24/60 (40%) | 11/60 (18%)  22/60 (37%)  21/60 (35%)  25/60 (42%) |
|ADJUSTED (b)           |  40.6%        59.6%        53.2%        48.5%      |  27.5%        46.4%        43.5%        52.5%      |
|INTERIM SACRIFICE 1 (c)|  1/10 (10%)   2/10 (20%)   0/10 (0%)    1/10 (10%) |  0/10 (0%)    0/10 (0%)    0/10 (0%)    0/10 (0%)  |
|TERMINAL (d)           | 17/46 (37%)  20/40 (50%)  17/39 (44%)  16/41 (39%) | 10/39 (26%)  15/40 (38%)  12/38 (32%)  15/37 (41%) |
|FIRST INCIDENCE (DAYS) |   456 (I)      456 (I)      507          456 (I)   |   698          414          320          317       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.480      P=0.021 *    P=0.095      P=0.181    |  P=0.024 *    P=0.030 *    P=0.038 *    P=0.005 ** |
|INCIDENTAL TUMOR       |  P=0.360N     P=0.093      P=0.324      P=0.468    |  P=0.031 *    P=0.047 *    P=0.058      P=0.009 ** |
|LOGISTIC REGRESSION    |  P=0.400N     P=0.101      P=0.316      P=0.449    |  P=0.028 *    P=0.027 *    P=0.038 *    P=0.006 ** |
|COCHRAN-ARMITAGE       |  P=0.527N                                          |  P=0.027 *                                         |
|FISHER EXACT           |               P=0.048 *    P=0.225      P=0.285    |               P=0.020 *    P=0.031 *    P=0.005 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 41/60 (68%)  49/60 (82%)  43/60 (72%)  53/60 (88%) | 39/60 (65%)  46/60 (77%)  44/60 (73%)  52/60 (87%) |
|ADJUSTED (b)           |  78.7%        92.4%        89.5%        96.3%      |  86.5%        90.1%        87.7%       100.0%      |
|INTERIM SACRIFICE 1 (c)|  2/10 (20%)   4/10 (40%)   1/10 (10%)   5/10 (50%) |  2/10 (20%)   3/10 (30%)   2/10 (20%)   3/10 (30%) |
|TERMINAL (d)           | 35/46 (76%)  36/40 (90%)  34/39 (87%)  39/41 (95%) | 33/39 (85%)  35/40 (88%)  32/38 (84%)  37/37 (100%)|
|FIRST INCIDENCE (DAYS) |   367          456 (I)      456 (I)      456 (I)   |   457 (I)      414          320          317       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.013 *    P=0.012 *    P=0.083      P=0.002 ** |  P=0.006 **   P=0.171      P=0.195      P=0.003 ** |
|INCIDENTAL TUMOR       |  P=0.014 *    P=0.068      P=0.358      P=0.005 ** |  P=0.004 **   P=0.256      P=0.335      P=0.003 ** |
|LOGISTIC REGRESSION    |  P=0.008 **   P=0.043 *    P=0.248      P=0.004 ** |  P=0.006 **   P=0.187      P=0.318      P=0.003 ** |
|COCHRAN-ARMITAGE       |  P=0.017 *                                         |  P=0.010 **                                        |
|FISHER EXACT           |               P=0.070      P=0.421      P=0.007 ** |               P=0.114      P=0.215      P=0.005 ** |
|=================================================================================================================================|
         DATE: 05/20/95                     EXPERIMENT: 05109 TEST: 12                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRIETHANOLAMINE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
                                                                           
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   456
          Female interim sacrifices(days): 457
 (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).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.