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TDMS Study 05069-06 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Mason                                        1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE                         DATE: 10/14/93       
EXPERIMENT: 05069 TEST: 06                                                                                     TIME: 15:50:46       
TEST TYPE:  INIT/PROMOT                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95256          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60902B       
PATHOLOGIST: M.E.P. GOAD                                                                                       CAS: 147-47-7        
------------------------------------------------------------------------------------------------------------------------------------
                                                    52 WEEK INITATION PROMOTION                                                     
               REASONS FOR REMOVAL:    ALL                                                                                          
               REMOVAL DATE RANGE:     ALL                                                                                          
               TREATMENT GROUPS:       INCLUDE 007    TMQ/TPA                                                                       
                                       INCLUDE 010    ACETONE/TPA                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Mason                                        1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE                         DATE: 10/14/93      
EXPERIMENT: 05069 TEST: 06                                                                                     TIME: 15:50:46      
TEST TYPE:  INIT/PROMOT                         CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95256          ROUTE: DERMAL,SOLUTION                                                             NTP C#: 60902B      
PATHOLOGIST: M.E.P. GOAD                                                                                       CAS: 147-47-7       
                                                    MICE(SENCAR)
                                              ----------------------------
             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.
                                                    ----------------
                                                    Clitoral Gland
                                                    Gallbladder
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Ovary
                                                    Spleen
                                                    Thymus
         DATE: 10/14/93                     EXPERIMENT: 05069 TEST: 06                                                 PAGE   1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE
                       TERMINAL SACRIFICE AT 54 WEEKS
|==============================================================================|
|DOSE                   |          ACETONE/            TMQ/TPA                 |
|                       |          TPA                                         |
|==============================================================================|
|                                                                              |
|Liver                                                                         |
|     Hepatocellular Adenoma                                                   |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |                                                      |
|-----------            |                                                      |
|OVERALL (a)            |         1/30 (3%)           2/30 (7%)                |
|ADJUSTED (b)           |          3.6%                8.0%                    |
|TERMINAL (d)           |         0/25 (0%)           2/25 (8%)                |
|FIRST INCIDENCE (DAYS) |          313                 372 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.496                  |
|INCIDENTAL TUMOR       |                             P=0.500                  |
|LOGISTIC REGRESSION    |                             P=0.501                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/30 (10%)          5/30 (17%)               |
|ADJUSTED (b)           |         11.3%               20.0%                    |
|TERMINAL (d)           |         2/25 (8%)           5/25 (20%)               |
|FIRST INCIDENCE (DAYS) |          313                 372 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.352                  |
|INCIDENTAL TUMOR       |                             P=0.354                  |
|LOGISTIC REGRESSION    |                             P=0.339                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.353                  |
|==============================================================================|
         DATE: 10/14/93                     EXPERIMENT: 05069 TEST: 06                                                 PAGE   2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE
                       TERMINAL SACRIFICE AT 54 WEEKS
|==============================================================================|
|DOSE                   |          ACETONE/            TMQ/TPA                 |
|                       |          TPA                                         |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Squamous Cell Papilloma                                                  |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/30 (10%)          4/30 (13%)               |
|ADJUSTED (b)           |         11.3%               16.0%                    |
|TERMINAL (d)           |         2/25 (8%)           4/25 (16%)               |
|FIRST INCIDENCE (DAYS) |          313                 372 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.497                  |
|INCIDENTAL TUMOR       |                             P=0.500                  |
|LOGISTIC REGRESSION    |                             P=0.489                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.500                  |
|==============================================================================|
|                                                                              |
|Skin                                                                          |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,             |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma        |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/30 (10%)          5/30 (17%)               |
|ADJUSTED (b)           |         11.3%               20.0%                    |
|TERMINAL (d)           |         2/25 (8%)           5/25 (20%)               |
|FIRST INCIDENCE (DAYS) |          313                 372 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.352                  |
|INCIDENTAL TUMOR       |                             P=0.354                  |
|LOGISTIC REGRESSION    |                             P=0.339                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.353                  |
|==============================================================================|
         DATE: 10/14/93                     EXPERIMENT: 05069 TEST: 06                                                 PAGE   3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE
                       TERMINAL SACRIFICE AT 54 WEEKS
|==============================================================================|
|DOSE                   |          ACETONE/            TMQ/TPA                 |
|                       |          TPA                                         |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Benign Tumors                                                            |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         3/30 (10%)          6/30 (20%)               |
|ADJUSTED (b)           |         11.3%               24.0%                    |
|TERMINAL (d)           |         2/25 (8%)           6/25 (24%)               |
|FIRST INCIDENCE (DAYS) |          313                 372 (T)                 |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.236                  |
|INCIDENTAL TUMOR       |                             P=0.238                  |
|LOGISTIC REGRESSION    |                             P=0.221                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.236                  |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant Tumors                                                         |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         2/30 (7%)           4/30 (13%)               |
|ADJUSTED (b)           |          7.3%               14.1%                    |
|TERMINAL (d)           |         0/25 (0%)           1/25 (4%)                |
|FIRST INCIDENCE (DAYS) |          313                 213                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.330                  |
|INCIDENTAL TUMOR       |                             P=0.303                  |
|LOGISTIC REGRESSION    |                             P=0.332                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.335                  |
|==============================================================================|
         DATE: 10/14/93                     EXPERIMENT: 05069 TEST: 06                                                 PAGE   4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE
                       TERMINAL SACRIFICE AT 54 WEEKS
|==============================================================================|
|DOSE                   |          ACETONE/            TMQ/TPA                 |
|                       |          TPA                                         |
|==============================================================================|
|                                                                              |
|All Organs                                                                    |
|     Malignant and Benign Tumors                                              |
|                                                                              |
|------------------------------------------------------------------------------|
|TUMOR RATES            |           #                   #                      |
|-----------            |                                                      |
|OVERALL (a)            |         4/30 (13%)         10/30 (33%)               |
|ADJUSTED (b)           |         14.7%               35.5%                    |
|TERMINAL (d)           |         2/25 (8%)           7/25 (28%)               |
|FIRST INCIDENCE (DAYS) |          313                 213                     |
|-----------------------|                                                      |
|STATISTICAL TESTS (f)  |                                                      |
|-----------------------|                                                      |
|LIFE TABLE             |                             P=0.076                  |
|INCIDENTAL TUMOR       |                             P=0.060                  |
|LOGISTIC REGRESSION    |                             P=0.065                  |
|COCHRAN-ARMITAGE       |                                                      |
|FISHER EXACT           |                             P=0.063                  |
|==============================================================================|
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).