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TDMS Study 05102-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95       
EXPERIMENT: 05102 TEST: 05                                                                                     TIME: 18:22:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B       
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 121-54-0        
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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                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95       
EXPERIMENT: 05102 TEST: 05                                                                                     TIME: 18:22:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B       
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 121-54-0        


                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                                    
                                                    ----------------
                                                    Adrenal Cortex
                                                    Adrenal Medulla
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Clitoral/Preputial Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95       
EXPERIMENT: 05102 TEST: 05                                                                                     TIME: 18:22:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B       
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 121-54-0        


                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                     IN THE ANALYSIS OF THE STUDY OF BENZETHONIUM CHLORIDE
              ====================================================================================================
                                                           MALE RATS
                                                          -------------
                  ORGAN                               MORPHOLOGY
                 -------                             ------------
              Pituitary Gland: Pars Distalis or Unspecified Site
                                            Adenoma
                                            Carcinoma or Adenoma
              Skin                          Basal Cell Adenoma or Basosquamous Tumor Benign
                                            Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma
                                            Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
                                             malignant or NOS), or Trichoepithelioma
                                            Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
                                             Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
                                            Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
                                            Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
                                            Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
              Testes                        Adenoma
              All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
                                            Benign Tumors
                                            Malignant and Benign Tumors
              ====================================================================================================
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   1
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/27 (19%)   0/0 (0%)     0/0 (0%)     7/29 (24%) |  3/10 (30%)   0/0 (0%)     0/0 (0%)     1/2 (50%)  |
|ADJUSTED (b)           |  31.0%         0.0%         0.0%        32.5%      |  50.0%         0.0%         0.0%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|TERMINAL (d)           |  2/8 (25%)    0/0          0/0          3/13 (23%) |  3/6 (50%)    0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   556          ---          ---          619       |   729 (T)      ---          ---          634       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.416      P=0.636N     P=0.489N     P=0.522    |  P=0.630        (e)          (e)        P=0.719    |
|INCIDENTAL TUMOR       |  P=0.350        (e)          (e)        P=0.391    |  P=0.555        (e)          (e)        P=0.649    |
|LOGISTIC REGRESSION    |  P=0.350        (e)          (e)        P=0.391    |  P=0.555        (e)          (e)        P=0.649    |
|COCHRAN-ARMITAGE       |  P=0.384                                           |  P=0.500                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.427    |               P=1.000N     P=1.000N     P=0.576    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/27 (19%)   0/0 (0%)     0/0 (0%)     8/29 (28%) |  3/10 (30%)   0/0 (0%)     0/0 (0%)     1/2 (50%)  |
|ADJUSTED (b)           |  31.0%         0.0%         0.0%        34.0%      |  50.0%         0.0%         0.0%         2.8%      |
|INTERIM SACRIFICE 1 (c)|  0/0          0/0          0/0          0/0        |  0/0          0/0          0/0          0/0        |
|TERMINAL (d)           |  2/8 (25%)    0/0          0/0          3/13 (23%) |  3/6 (50%)    0/0          0/0          0/1 (0%)   |
|FIRST INCIDENCE (DAYS) |   556          ---          ---          556       |   729 (T)      ---          ---          634       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.299      P=0.636N     P=0.489N     P=0.405    |  P=0.630        (e)          (e)        P=0.719    |
|INCIDENTAL TUMOR       |  P=0.234        (e)          (e)        P=0.267    |  P=0.555        (e)          (e)        P=0.649    |
|LOGISTIC REGRESSION    |  P=0.234        (e)          (e)        P=0.267    |  P=0.555        (e)          (e)        P=0.649    |
|COCHRAN-ARMITAGE       |  P=0.277                                           |  P=0.500                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.315    |               P=1.000N     P=1.000N     P=0.576    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   2
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/0 (0%)     0/0 (0%)     1/60 (2%)  |  4/59 (7%)    0/0 (0%)     0/0 (0%)     4/59 (7%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         2.1%      |  11.9%         0.0%         0.0%        16.7%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  1/9 (11%)    0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          0/16 (0%)  |  2/24 (8%)    0/0          0/0          4/24 (17%) |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          549       |   456 (I)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.334        (e)          (e)        P=0.496    |  P=0.577      P=0.999N     P=0.965N     P=0.627    |
|INCIDENTAL TUMOR       |  P=0.393        (e)          (e)        P=0.525    |  P=0.589N       (e)          (e)        P=0.636N   |
|LOGISTIC REGRESSION    |  P=0.393        (e)          (e)        P=0.525    |  P=0.589N       (e)          (e)        P=0.636N   |
|COCHRAN-ARMITAGE       |  P=0.369                                           |  P=0.596                                           |
|FISHER EXACT           |                 (e)          (e)        P=0.500    |               P=1.000N     P=1.000N     P=0.642N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/0 (0%)     0/0 (0%)     0/60 (0%)  |  0/59 (0%)    0/0 (0%)     0/0 (0%)     2/59 (3%)  |
|ADJUSTED (b)           |   4.4%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         8.3%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          0/16 (0%)  |  0/24 (0%)    0/0          0/0          2/24 (8%)  |
|FIRST INCIDENCE (DAYS) |   437          ---          ---          ---       |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.196N     P=0.770N     P=0.641N     P=0.253N   |  P=0.170        (e)          (e)        P=0.237    |
|INCIDENTAL TUMOR       |  P=0.127N       (e)          (e)        P=0.183N   |  P=0.170        (e)          (e)        P=0.237    |
|LOGISTIC REGRESSION    |  P=0.127N       (e)          (e)        P=0.183N   |  P=0.170        (e)          (e)        P=0.237    |
|COCHRAN-ARMITAGE       |  P=0.171N                                          |  P=0.171                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.248N   |                 (e)          (e)        P=0.248    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   3
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/0 (0%)     0/0 (0%)     1/60 (2%)  |  4/59 (7%)    0/0 (0%)     0/0 (0%)     6/59 (10%) |
|ADJUSTED (b)           |   4.4%         0.0%         0.0%         2.1%      |  11.9%         0.0%         0.0%        25.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  1/9 (11%)    0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          0/16 (0%)  |  2/24 (8%)    0/0          0/0          6/24 (25%) |
|FIRST INCIDENCE (DAYS) |   437          ---          ---          549       |   456 (I)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.481N     P=0.770N     P=0.641N     P=0.516N   |  P=0.309      P=0.999N     P=0.965N     P=0.352    |
|INCIDENTAL TUMOR       |  P=0.349N       (e)          (e)        P=0.424N   |  P=0.333        (e)          (e)        P=0.375    |
|LOGISTIC REGRESSION    |  P=0.349N       (e)          (e)        P=0.424N   |  P=0.333        (e)          (e)        P=0.375    |
|COCHRAN-ARMITAGE       |  P=0.423N                                          |  P=0.330                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.500N   |               P=1.000N     P=1.000N     P=0.371    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |  17.9%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  2/15 (13%)   0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   714          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.103N     P=0.444N     P=0.520N     P=0.117N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.106N     P=0.556N     P=0.491N     P=0.128N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.098N     P=0.499N     P=0.526N     P=0.115N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.094N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.748N     P=0.653N     P=0.122N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   4
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/0 (0%)     0/0 (0%)     3/60 (5%)  |  0/60 (0%)    0/0 (0%)     0/0 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%        18.8%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          3/16 (19%) |  0/24 (0%)    0/0          0/0          0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   634          ---          ---          729 (T)   |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.248      P=0.905N     P=0.790N     P=0.322    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.273        (e)          (e)        P=0.333    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.273        (e)          (e)        P=0.333    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.249                                           |    (e)                                             |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.309    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/0 (0%)     0/0 (0%)     3/60 (5%)  |  0/60 (0%)    0/0 (0%)     0/0 (0%)     1/60 (2%)  |
|ADJUSTED (b)           |   2.9%         0.0%         0.0%        18.8%      |   0.0%         0.0%         0.0%         3.7%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          3/16 (19%) |  0/24 (0%)    0/0          0/0          0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   634          ---          ---          729 (T)   |   ---          ---          ---          699       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.248      P=0.905N     P=0.790N     P=0.322    |  P=0.330        (e)          (e)        P=0.472    |
|INCIDENTAL TUMOR       |  P=0.273        (e)          (e)        P=0.333    |  P=0.315        (e)          (e)        P=0.443    |
|LOGISTIC REGRESSION    |  P=0.273        (e)          (e)        P=0.333    |  P=0.315        (e)          (e)        P=0.443    |
|COCHRAN-ARMITAGE       |  P=0.249                                           |  P=0.369                                           |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.309    |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   5
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  3/60 (5%)    0/1 (0%)     0/3 (0%)     2/60 (3%)  |
|ADJUSTED (b)           |   6.7%         0.0%         0.0%         0.0%      |  10.5%         0.0%         0.0%         7.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  1/24 (4%)    0/1 (0%)     0/3 (0%)     1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   648          ---          ---          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.484N     P=0.893N     P=0.656N     P=0.518N   |
|INCIDENTAL TUMOR       |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.531N     P=0.991N     P=0.892N     P=0.579N   |
|LOGISTIC REGRESSION    |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.483N     P=0.950N     P=0.753N     P=0.527N   |
|COCHRAN-ARMITAGE       |  P=0.387N                                          |  P=0.452N                                          |
|FISHER EXACT           |               P=0.909N     P=0.870N     P=0.500N   |               P=0.951N     P=0.862N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  3/60 (5%)    0/1 (0%)     0/3 (0%)     3/60 (5%)  |
|ADJUSTED (b)           |   6.7%         0.0%         0.0%         0.0%      |  10.5%         0.0%         0.0%        11.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  1/24 (4%)    0/1 (0%)     0/3 (0%)     2/24 (8%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   648          ---          ---          658       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.565      P=0.893N     P=0.656N     P=0.645    |
|INCIDENTAL TUMOR       |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.523      P=0.991N     P=0.892N     P=0.596    |
|LOGISTIC REGRESSION    |  P=0.396N     P=0.761N     P=0.814N     P=0.487N   |  P=0.559      P=0.950N     P=0.753N     P=0.633    |
|COCHRAN-ARMITAGE       |  P=0.387N                                          |  P=0.597                                           |
|FISHER EXACT           |               P=0.909N     P=0.870N     P=0.500N   |               P=0.951N     P=0.862N     P=0.660N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   6
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/6 (0%)     0/9 (0%)     3/60 (5%)  | 17/60 (28%)   0/1 (0%)     0/3 (0%)    17/60 (28%) |
|ADJUSTED (b)           |   2.5%         0.0%         0.0%        17.4%      |  53.6%         0.0%         0.0%        56.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     2/16 (13%) | 10/24 (42%)   0/1 (0%)     0/3 (0%)    12/24 (50%) |
|FIRST INCIDENCE (DAYS) |   606          ---          ---          722       |   572          ---          ---          525       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.194      P=0.923N     P=0.814N     P=0.329    |  P=0.433      P=0.431N     P=0.132N     P=0.545    |
|INCIDENTAL TUMOR       |  P=0.192      P=0.965N     P=0.882N     P=0.307    |  P=0.415      P=0.581N     P=0.223N     P=0.510    |
|LOGISTIC REGRESSION    |  P=0.185      P=0.933N     P=0.897N     P=0.299    |  P=0.409      P=0.536N     P=0.168N     P=0.498    |
|COCHRAN-ARMITAGE       |  P=0.204                                           |  P=0.514                                           |
|FISHER EXACT           |               P=0.909N     P=0.870N     P=0.309    |               P=0.721N     P=0.382N     P=0.580N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    0/6 (0%)     0/9 (0%)     1/60 (2%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     1/60 (2%)  |
|ADJUSTED (b)           |  16.1%         0.0%         0.0%         4.3%      |   0.0%         0.0%         0.0%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  2/15 (13%)   0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   648          ---          ---          683       |   ---          ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.302N     P=0.478N     P=0.489N     P=0.302N   |  P=0.352        (e)          (e)        P=0.500    |
|INCIDENTAL TUMOR       |  P=0.320N     P=0.556N     P=0.491N     P=0.339N   |  P=0.352        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.293N     P=0.587N     P=0.507N     P=0.308N   |  P=0.352        (e)          (e)        P=0.500    |
|COCHRAN-ARMITAGE       |  P=0.280N                                          |  P=0.362                                           |
|FISHER EXACT           |               P=0.748N     P=0.653N     P=0.309N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   7
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/6 (0%)     0/9 (0%)     4/60 (7%)  | 19/60 (32%)   0/1 (0%)     0/3 (0%)    19/60 (32%) |
|ADJUSTED (b)           |  24.5%         0.0%         0.0%        21.0%      |  56.6%         0.0%         0.0%        61.1%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  3/15 (20%)   0/4 (0%)     0/3 (0%)     2/16 (13%) | 10/24 (42%)   0/1 (0%)     0/3 (0%)    13/24 (54%) |
|FIRST INCIDENCE (DAYS) |   606          ---          ---          683       |   572          ---          ---          525       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.558N     P=0.335N     P=0.333N     P=0.475N   |  P=0.420      P=0.400N     P=0.115N     P=0.535    |
|INCIDENTAL TUMOR       |  P=0.575N     P=0.392N     P=0.352N     P=0.521N   |  P=0.377      P=0.581N     P=0.223N     P=0.473    |
|LOGISTIC REGRESSION    |  P=0.560N     P=0.455N     P=0.350N     P=0.507N   |  P=0.400      P=0.503N     P=0.137N     P=0.492    |
|COCHRAN-ARMITAGE       |  P=0.527N                                          |  P=0.509                                           |
|FISHER EXACT           |               P=0.611N     P=0.486N     P=0.500N   |               P=0.689N     P=0.334N     P=0.578N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/60 (8%)    0/6 (0%)     0/9 (0%)     4/60 (7%)  | 19/60 (32%)   0/1 (0%)     0/3 (0%)    20/60 (33%) |
|ADJUSTED (b)           |  24.5%         0.0%         0.0%        21.0%      |  56.6%         0.0%         0.0%        64.7%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  3/15 (20%)   0/4 (0%)     0/3 (0%)     2/16 (13%) | 10/24 (42%)   0/1 (0%)     0/3 (0%)    14/24 (58%) |
|FIRST INCIDENCE (DAYS) |   606          ---          ---          683       |   572          ---          ---          525       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.558N     P=0.335N     P=0.333N     P=0.475N   |  P=0.344      P=0.400N     P=0.115N     P=0.458    |
|INCIDENTAL TUMOR       |  P=0.575N     P=0.392N     P=0.352N     P=0.521N   |  P=0.296      P=0.581N     P=0.223N     P=0.388    |
|LOGISTIC REGRESSION    |  P=0.560N     P=0.455N     P=0.350N     P=0.507N   |  P=0.314      P=0.503N     P=0.137N     P=0.404    |
|COCHRAN-ARMITAGE       |  P=0.527N                                          |  P=0.430                                           |
|FISHER EXACT           |               P=0.611N     P=0.486N     P=0.500N   |               P=0.689N     P=0.334N     P=0.500    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   8
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   7.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   653          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.183N     P=0.703N     P=0.570N     P=0.232N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.214N       (e)        P=0.601N     P=0.293N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.187N     P=0.770N     P=0.673N     P=0.242N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.183N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.825N     P=0.754N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/60 (57%)   0/0 (0%)     0/0 (0%)    25/60 (42%) | 29/60 (48%)   0/0 (0%)     0/0 (0%)    28/60 (47%) |
|ADJUSTED (b)           |  85.1%         0.0%         0.0%        66.2%      |  74.4%         0.0%         0.0%        66.1%      |
|INTERIM SACRIFICE 1 (c)|  3/8 (38%)    0/0          0/0          2/4 (50%)  |  1/9 (11%)    0/0          0/0          1/7 (14%)  |
|TERMINAL (d)           | 10/15 (67%)   0/0          0/0          6/16 (38%) | 15/24 (63%)   0/0          0/0         11/24 (46%) |
|FIRST INCIDENCE (DAYS) |   406          ---          ---          408       |   456 (I)      ---          ---          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.272N     P=0.078N     P=0.041N*    P=0.171N   |  P=0.498      P=0.603N     P=0.304N     P=0.557    |
|INCIDENTAL TUMOR       |  P=0.108N       (e)          (e)        P=0.120N   |  P=0.526N       (e)          (e)        P=0.551N   |
|LOGISTIC REGRESSION    |  P=0.108N       (e)          (e)        P=0.120N   |  P=0.526N       (e)          (e)        P=0.551N   |
|COCHRAN-ARMITAGE       |  P=0.064N                                          |  P=0.476N                                          |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.072N   |               P=1.000N     P=1.000N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE   9
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/0 (0%)     0/0 (0%)     0/60 (0%)  |  2/60 (3%)    0/0 (0%)     0/0 (0%)     2/60 (3%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   7.9%         0.0%         0.0%         6.1%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          0/16 (0%)  |  1/24 (4%)    0/0          0/0          0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   724          ---          ---          562       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.608      P=0.993N     P=0.904N     P=0.683    |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.603        (e)          (e)        P=0.667    |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.603        (e)          (e)        P=0.667    |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.633                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |               P=1.000N     P=1.000N     P=0.691N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 34/60 (57%)   0/0 (0%)     0/0 (0%)    25/60 (42%) | 31/60 (52%)   0/0 (0%)     0/0 (0%)    30/60 (50%) |
|ADJUSTED (b)           |  85.1%         0.0%         0.0%        66.2%      |  78.1%         0.0%         0.0%        68.2%      |
|INTERIM SACRIFICE 1 (c)|  3/8 (38%)    0/0          0/0          2/4 (50%)  |  1/9 (11%)    0/0          0/0          1/7 (14%)  |
|TERMINAL (d)           | 10/15 (67%)   0/0          0/0          6/16 (38%) | 16/24 (67%)   0/0          0/0         11/24 (46%) |
|FIRST INCIDENCE (DAYS) |   406          ---          ---          408       |   456 (I)      ---          ---          456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.272N     P=0.078N     P=0.041N*    P=0.171N   |  P=0.490      P=0.574N     P=0.276N     P=0.552    |
|INCIDENTAL TUMOR       |  P=0.108N       (e)          (e)        P=0.120N   |  P=0.538N       (e)          (e)        P=0.564N   |
|LOGISTIC REGRESSION    |  P=0.108N       (e)          (e)        P=0.120N   |  P=0.538N       (e)          (e)        P=0.564N   |
|COCHRAN-ARMITAGE       |  P=0.064N                                          |  P=0.476N                                          |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.072N   |               P=1.000N     P=1.000N     P=0.500N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  10
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma or Basosquamous Tumor Benign                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/6 (0%)     2/9 (22%)    0/60 (0%)  |  1/60 (2%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        34.4%         0.0%      |   3.7%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          635          ---       |   722          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.552N       (e)        P=0.016 *      (e)      |  P=0.392N     P=0.994N     P=0.909N     P=0.515N   |
|INCIDENTAL TUMOR       |  P=0.539N       (e)        P=0.008 **     (e)      |  P=0.424N       (e)          (e)        P=0.557N   |
|LOGISTIC REGRESSION    |  P=0.545N       (e)        P=0.007 **     (e)      |  P=0.396N     P=0.997N     P=0.935N     P=0.523N   |
|COCHRAN-ARMITAGE       |  P=0.534N                                          |  P=0.373N                                          |
|FISHER EXACT           |                 (e)        P=0.015 *      (e)      |               P=0.984N     P=0.952N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/6 (0%)     2/9 (22%)    0/60 (0%)  |  1/60 (2%)    0/1 (0%)     1/3 (33%)    0/60 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%        34.4%         0.0%      |   3.7%         0.0%        33.3%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     1/3 (33%)    0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          635          ---       |   722          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.552N       (e)        P=0.016 *      (e)      |  P=0.340N     P=0.994N     P=0.253      P=0.515N   |
|INCIDENTAL TUMOR       |  P=0.539N       (e)        P=0.008 **     (e)      |  P=0.362N       (e)        P=0.108      P=0.557N   |
|LOGISTIC REGRESSION    |  P=0.545N       (e)        P=0.007 **     (e)      |  P=0.357N     P=0.997N     P=0.207      P=0.523N   |
|COCHRAN-ARMITAGE       |  P=0.534N                                          |  P=0.323N                                          |
|FISHER EXACT           |                 (e)        P=0.015 *      (e)      |               P=0.984N     P=0.094      P=0.500N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  11
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,                                                       |
|     malignant or NOS), or Trichoepithelioma                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    0/6 (0%)     2/9 (22%)    0/60 (0%)  |  1/60 (2%)    0/1 (0%)     1/3 (33%)    1/60 (2%)  |
|ADJUSTED (b)           |   0.0%         0.0%        34.4%         0.0%      |   3.7%         0.0%        33.3%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     1/3 (33%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          635          ---       |   722          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.552N       (e)        P=0.016 *      (e)      |  P=0.611N     P=0.994N     P=0.253      P=0.752    |
|INCIDENTAL TUMOR       |  P=0.539N       (e)        P=0.008 **     (e)      |  P=0.627N       (e)        P=0.108      P=0.729    |
|LOGISTIC REGRESSION    |  P=0.545N       (e)        P=0.007 **     (e)      |  P=0.642N     P=0.997N     P=0.207      P=0.737    |
|COCHRAN-ARMITAGE       |  P=0.534N                                          |  P=0.588N                                          |
|FISHER EXACT           |                 (e)        P=0.015 *      (e)      |               P=0.984N     P=0.094      P=0.752N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal                                                       |
|     Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     6/9 (67%)    2/60 (3%)  |  1/60 (2%)    0/1 (0%)     1/3 (33%)    1/60 (2%)  |
|ADJUSTED (b)           |  11.9%         0.0%        84.4%         9.7%      |   3.7%         0.0%        33.3%         4.2%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     2/3 (67%)    1/16 (6%)  |  0/24 (0%)    0/1 (0%)     1/3 (33%)    1/24 (4%)  |
|FIRST INCIDENCE (DAYS) |   716          ---          635          660       |   722          ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.436N     P=0.576N     P<0.001 **   P=0.675N   |  P=0.611N     P=0.994N     P=0.253      P=0.752    |
|INCIDENTAL TUMOR       |  P=0.462N     P=0.761N     P<0.001 **   P=0.661    |  P=0.627N       (e)        P=0.108      P=0.729    |
|LOGISTIC REGRESSION    |  P=0.427N     P=0.638N     P<0.001 **   P=0.694    |  P=0.642N     P=0.997N     P=0.207      P=0.737    |
|COCHRAN-ARMITAGE       |  P=0.398N                                          |  P=0.588N                                          |
|FISHER EXACT           |               P=0.825N     P<0.001 **   P=0.691N   |               P=0.984N     P=0.094      P=0.752N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  12
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/6 (33%)    1/9 (11%)    1/60 (2%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   0.0%        37.5%        11.1%         2.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    1/4 (25%)    0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          457          556          639       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.504N     P=0.010 *    P=0.182      P=0.506    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.433N     P=0.028 *    P=0.118      P=0.525    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.471N     P<0.001 **   P=0.052      P=0.497    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.492N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.007 **   P=0.130      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/60 (0%)    2/6 (33%)    0/9 (0%)     0/60 (0%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   0.0%        37.5%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    1/4 (25%)    0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          457          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.280N     P=0.010 *      (e)          (e)      |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.240N     P=0.028 *      (e)          (e)      |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.258N     P<0.001 **     (e)          (e)      |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.272N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.007 **     (e)          (e)      |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  13
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/6 (0%)     4/9 (44%)    1/60 (2%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   6.7%         0.0%        76.2%         3.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     2/3 (67%)    0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          663          660       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.471N     P=0.761N     P<0.001 **   P=0.745N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.505N     P=0.761N     P<0.001 **   P=0.740    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.469N     P=0.761N     P<0.001 **   P=0.760    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.445N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.909N     P<0.001 **   P=0.752N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     4/9 (44%)    2/60 (3%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |  11.9%         0.0%        76.2%         9.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     2/3 (67%)    1/16 (6%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   716          ---          663          660       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.503N     P=0.576N     P=0.003 **   P=0.675N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.541N     P=0.761N     P=0.003 **   P=0.661    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.500N     P=0.638N     P=0.001 **   P=0.694    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.469N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.825N     P=0.002 **   P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  14
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma, Papilloma, or Keratoacanthoma                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     4/9 (44%)    2/60 (3%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |  11.9%         0.0%        76.2%         9.7%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     2/3 (67%)    1/16 (6%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   716          ---          663          660       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.503N     P=0.576N     P=0.003 **   P=0.675N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.541N     P=0.761N     P=0.003 **   P=0.661    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.500N     P=0.638N     P=0.001 **   P=0.694    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.469N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.825N     P=0.002 **   P=0.691N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 45/60 (75%)   0/0 (0%)     0/0 (0%)    40/60 (67%) |                                                    |
|ADJUSTED (b)           | 100.0%         0.0%         0.0%        97.3%      |                                                    |
|INTERIM SACRIFICE 1 (c)|  3/8 (38%)    0/0          0/0          0/4 (0%)   |                                                    |
|TERMINAL (d)           | 15/15 (100%)  0/0          0/0         15/16 (94%) |                                                    |
|FIRST INCIDENCE (DAYS) |   456 (I)      ---          ---          465       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.480N     P=0.047N*    P=0.020N*    P=0.292N   |                                                    |
|INCIDENTAL TUMOR       |  P=0.227N       (e)          (e)        P=0.252N   |                                                    |
|LOGISTIC REGRESSION    |  P=0.227N       (e)          (e)        P=0.252N   |                                                    |
|COCHRAN-ARMITAGE       |  P=0.192N                                          |                                                    |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.211N   |                                                    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  15
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/59 (12%)   0/0 (0%)     0/0 (0%)     9/60 (15%) | 11/60 (18%)   0/0 (0%)     0/0 (0%)     5/60 (8%)  |
|ADJUSTED (b)           |  33.5%         0.0%         0.0%        33.8%      |  35.1%         0.0%         0.0%        18.8%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          2/4 (50%)  |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  4/15 (27%)   0/0          0/0          4/16 (25%) |  6/24 (25%)   0/0          0/0          4/24 (17%) |
|FIRST INCIDENCE (DAYS) |   585          ---          ---          456 (I)   |   515          ---          ---          613       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.274      P=0.617N     P=0.495N     P=0.352    |  P=0.088N     P=0.837N     P=0.570N     P=0.099N   |
|INCIDENTAL TUMOR       |  P=0.319        (e)          (e)        P=0.352    |  P=0.081N       (e)          (e)        P=0.095N   |
|LOGISTIC REGRESSION    |  P=0.319        (e)          (e)        P=0.352    |  P=0.081N       (e)          (e)        P=0.095N   |
|COCHRAN-ARMITAGE       |  P=0.374                                           |  P=0.076N                                          |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.409    |               P=1.000N     P=1.000N     P=0.089N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/59 (12%)   0/0 (0%)     0/0 (0%)     9/60 (15%) | 11/60 (18%)   0/0 (0%)     0/0 (0%)     5/60 (8%)  |
|ADJUSTED (b)           |  33.5%         0.0%         0.0%        33.8%      |  35.1%         0.0%         0.0%        18.8%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          2/4 (50%)  |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  4/15 (27%)   0/0          0/0          4/16 (25%) |  6/24 (25%)   0/0          0/0          4/24 (17%) |
|FIRST INCIDENCE (DAYS) |   585          ---          ---          456 (I)   |   515          ---          ---          613       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.274      P=0.617N     P=0.495N     P=0.352    |  P=0.088N     P=0.837N     P=0.570N     P=0.099N   |
|INCIDENTAL TUMOR       |  P=0.319        (e)          (e)        P=0.352    |  P=0.081N       (e)          (e)        P=0.095N   |
|LOGISTIC REGRESSION    |  P=0.319        (e)          (e)        P=0.352    |  P=0.081N       (e)          (e)        P=0.095N   |
|COCHRAN-ARMITAGE       |  P=0.374                                           |  P=0.076N                                          |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.409    |               P=1.000N     P=1.000N     P=0.089N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  16
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/59 (2%)    0/0 (0%)     0/0 (0%)     2/60 (3%)  |  0/60 (0%)    0/0 (0%)     0/0 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   4.0%         0.0%         0.0%         7.3%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/0          0/0          0/16 (0%)  |  0/24 (0%)    0/0          0/0          0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   679          ---          ---          643       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.352      P=0.853N     P=0.814N     P=0.487    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.387        (e)          (e)        P=0.464    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.387        (e)          (e)        P=0.464    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.429                                           |    (e)                                             |
|FISHER EXACT           |               P=1.000N     P=1.000N     P=0.506    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |  3/60 (5%)    0/1 (0%)     0/3 (0%)     7/60 (12%) |
|ADJUSTED (b)           |                                                    |  10.2%         0.0%         0.0%        22.0%      |
|INTERIM SACRIFICE 1 (c)|                                                    |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |                                                    |  2/24 (8%)    0/1 (0%)     0/3 (0%)     4/24 (17%) |
|FIRST INCIDENCE (DAYS) |                                                    |   485          ---          ---          533       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.116      P=0.906N     P=0.673N     P=0.166    |
|INCIDENTAL TUMOR       |                                                    |  P=0.117      P=0.939N     P=0.738N     P=0.162    |
|LOGISTIC REGRESSION    |                                                    |  P=0.118      P=0.980N     P=0.836N     P=0.156    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.123                                           |
|FISHER EXACT           |                                                    |               P=0.951N     P=0.862N     P=0.161    |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  17
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   9.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  1/15 (7%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   606          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.188N     P=0.655N     P=0.624N     P=0.233N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.175N     P=0.684N     P=0.669N     P=0.219N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.188N     P=0.757N     P=0.658N     P=0.242N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.183N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.825N     P=0.754N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/60 (3%)    0/6 (0%)     0/9 (0%)     0/60 (0%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   6.3%         0.0%         0.0%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   612          ---          ---          ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.177N     P=0.729N     P=0.583N     P=0.226N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.187N     P=0.965N     P=0.655N     P=0.253N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.184N     P=0.785N     P=0.698N     P=0.240N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.183N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.825N     P=0.754N     P=0.248N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  18
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/6 (17%)    1/9 (11%)    3/60 (5%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   6.2%        20.0%        33.3%        10.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     1/3 (33%)    1/16 (6%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   513          579          729 (T)      557       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.522N     P=0.412      P=0.571      P=0.657    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.427N     P=0.420      P=0.433      P=0.587N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.482N     P=0.359      P=0.444      P=0.646N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.499N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.323      P=0.436      P=0.660N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 23/60 (38%)   0/6 (0%)     0/9 (0%)    30/60 (50%) | 18/60 (30%)   0/1 (0%)     0/3 (0%)    18/60 (30%) |
|ADJUSTED (b)           |  61.7%         0.0%         0.0%        82.0%      |  47.8%         0.0%         0.0%        53.7%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  5/15 (33%)   0/4 (0%)     0/3 (0%)    11/16 (69%) |  6/24 (25%)   0/1 (0%)     0/3 (0%)    10/24 (42%) |
|FIRST INCIDENCE (DAYS) |   549          ---          ---          396       |   485          ---          ---          303       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.055      P=0.051N     P=0.027N*    P=0.211    |  P=0.417      P=0.452N     P=0.164N     P=0.515    |
|INCIDENTAL TUMOR       |  P=0.046 *    P=0.091N     P=0.013N*    P=0.169    |  P=0.496      P=0.729N     P=0.405N     P=0.570    |
|LOGISTIC REGRESSION    |  P=0.025 *    P=0.064N     P=0.021N*    P=0.089    |  P=0.454      P=0.587N     P=0.221N     P=0.533    |
|COCHRAN-ARMITAGE       |  P=0.042 *                                         |  P=0.512                                           |
|FISHER EXACT           |               P=0.067N     P=0.019N*    P=0.135    |               P=0.705N     P=0.357N     P=0.579N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  19
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/60 (5%)    1/6 (17%)    1/9 (11%)    3/60 (5%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   6.2%        20.0%        33.3%        10.9%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     1/3 (33%)    1/16 (6%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   513          579          729 (T)      557       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.522N     P=0.412      P=0.571      P=0.657    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.427N     P=0.420      P=0.433      P=0.587N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.482N     P=0.359      P=0.444      P=0.646N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.499N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.323      P=0.436      P=0.660N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma: Benign, Malignant, NOS                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/60 (2%)    0/6 (0%)     0/9 (0%)     2/60 (3%)  |  0/60 (0%)    0/1 (0%)     0/3 (0%)     0/60 (0%)  |
|ADJUSTED (b)           |   4.8%         0.0%         0.0%         4.6%      |   0.0%         0.0%         0.0%         0.0%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  0/9 (0%)     0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  0/15 (0%)    0/4 (0%)     0/3 (0%)     0/16 (0%)  |  0/24 (0%)    0/1 (0%)     0/3 (0%)     0/24 (0%)  |
|FIRST INCIDENCE (DAYS) |   709          ---          ---          364       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.364      P=0.823N     P=0.872N     P=0.494    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.654        (e)        P=0.795N     P=0.747    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.415      P=0.863N     P=0.822N     P=0.528    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.379                                           |    (e)                                             |
|FISHER EXACT           |               P=0.909N     P=0.870N     P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  20
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 55/60 (92%)   0/6 (0%)     7/9 (78%)   54/60 (90%) | 41/60 (68%)   0/1 (0%)     1/3 (33%)   42/60 (70%) |
|ADJUSTED (b)           | 100.0%         0.0%        86.1%       100.0%      |  88.7%         0.0%        33.3%        93.0%      |
|INTERIM SACRIFICE 1 (c)|  5/8 (63%)    0/0          0/0          3/4 (75%)  |  3/9 (33%)    0/0          0/0          1/7 (14%)  |
|TERMINAL (d)           | 15/15 (100%)  0/4 (0%)     2/3 (67%)   16/16 (100%)| 19/24 (79%)   0/1 (0%)     1/3 (33%)   21/24 (88%) |
|FIRST INCIDENCE (DAYS) |   406          ---          556          364       |   456 (I)      ---          729 (T)      456 (I)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.196      P<0.001N**   P=0.201N     P=0.508    |  P=0.286      P=0.171N     P=0.053N     P=0.406    |
|INCIDENTAL TUMOR       |  P=0.118      P<0.001N**   P=0.094N     P=0.610    |  P=0.242      P=0.271N     P=0.161N     P=0.348    |
|LOGISTIC REGRESSION    |  P=0.136      P<0.001N**   P=0.085N     P=0.520    |  P=0.317      P=0.232N     P=0.113N     P=0.428    |
|COCHRAN-ARMITAGE       |  P=0.243                                           |  P=0.406                                           |
|FISHER EXACT           |               P<0.001N**   P=0.224N     P=0.500N   |               P=0.328N     P=0.256N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 30/60 (50%)   3/6 (50%)    2/9 (22%)   33/60 (55%) | 23/60 (38%)   0/1 (0%)     1/3 (33%)   21/60 (35%) |
|ADJUSTED (b)           |  70.7%        50.0%        66.7%        83.3%      |  57.2%         0.0%        33.3%        59.4%      |
|INTERIM SACRIFICE 1 (c)|  0/8 (0%)     0/0          0/0          0/4 (0%)   |  1/9 (11%)    0/0          0/0          0/7 (0%)   |
|TERMINAL (d)           |  6/15 (40%)   1/4 (25%)    2/3 (67%)   11/16 (69%) |  8/24 (33%)   0/1 (0%)     1/3 (33%)   11/24 (46%) |
|FIRST INCIDENCE (DAYS) |   437          457          729 (T)      396       |   456 (I)      ---          729 (T)      303       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.268      P=0.330N     P=0.081N     P=0.419    |  P=0.542N     P=0.386N     P=0.307N     P=0.503N   |
|INCIDENTAL TUMOR       |  P=0.363      P=0.681N     P=0.070N     P=0.480    |  P=0.447N     P=0.650N     P=0.738      P=0.445N   |
|LOGISTIC REGRESSION    |  P=0.198      P=0.426      P=0.063N     P=0.249    |  P=0.481N     P=0.520N     P=0.534N     P=0.470N   |
|COCHRAN-ARMITAGE       |  P=0.283                                           |  P=0.424N                                          |
|FISHER EXACT           |               P=0.664N     P=0.114N     P=0.357    |               P=0.623N     P=0.678N     P=0.425N   |
|=================================================================================================================================|
         DATE: 05/19/95                     EXPERIMENT: 05102 TEST: 05                                                 PAGE  21
                          STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZETHONIUM CHLORIDE
                                                 TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |   0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG  |
|                       |                                                    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 57/60 (95%)   3/6 (50%)    8/9 (89%)   57/60 (95%) | 46/60 (77%)   0/1 (0%)     2/3 (67%)   50/60 (83%) |
|ADJUSTED (b)           | 100.0%        50.0%       100.0%       100.0%      |  91.8%         0.0%        66.7%        98.0%      |
|INTERIM SACRIFICE 1 (c)|  5/8 (63%)    0/0          0/0          3/4 (75%)  |  3/9 (33%)    0/0          0/0          1/7 (14%)  |
|TERMINAL (d)           | 15/15 (100%)  1/4 (25%)    3/3 (100%)  16/16 (100%)| 20/24 (83%)   0/1 (0%)     2/3 (67%)   23/24 (96%) |
|FIRST INCIDENCE (DAYS) |   406          457          556          364       |   456 (I)      ---          729 (T)      303       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.240      P=0.017N*    P=0.270N     P=0.461    |  P=0.167      P=0.145N     P=0.114N     P=0.257    |
|INCIDENTAL TUMOR       |  P=0.170      P=0.003N**   P=0.205N     P=0.582    |  P=0.095      P=0.227N     P=0.534N     P=0.153    |
|LOGISTIC REGRESSION    |  P=0.061      P<0.001N**   P=0.227N     P=0.247    |  P=0.105      P=0.137N     P=0.416N     P=0.163    |
|COCHRAN-ARMITAGE       |  P=0.305                                           |  P=0.181                                           |
|FISHER EXACT           |               P=0.008N**   P=0.436N     P=0.660N   |               P=0.246N     P=0.564N     P=0.247    |
|=================================================================================================================================|
 (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): 456
 (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).