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TDMS Study 89029-11 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Northwest                        MAGNETIC FIELDS + DMBA INITIATION PROMOTION                     DATE: 12/19/97       
EXPERIMENT: 89029 TEST: 11                                                                                     TIME: 14:14:04       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65397                              ROUTE: MAGNETIC FIELDS                                         NTP C#: 89029D       
PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: EMF+DMBA        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                       10(10MGX1)DMBA VS 60HZ/1G 10MG(10MGX1)DMBA                                             
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    10 DMBA CONTROL                                                               
                                       INCLUDE 004    60 HZ/1G 10 DMBA                                                              

 NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
 LAB: Battelle Northwest                        MAGNETIC FIELDS + DMBA INITIATION PROMOTION                     DATE: 12/18/97       
 EXPERIMENT: 89029 TEST: 11                                                                                     TIME: 13:29:36       
 TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
 CONT: N01-ES-65397                              ROUTE: MAGNETIC FIELDS                                         NTP C#: 89029D       
 PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: EMF+DMBA        
 
 
                                      SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                             IN THE ANALYSIS OF THE STUDY OF A  MAGNETIC FIELDS + DMBA INITIATION PRO
               ====================================================================================================
                                                            FEMALE RATS
                                                           -------------
                                  ORGAN                               MORPHOLOGY
                                 -------                             ------------
                              Lung                          Hyperplasia
               ====================================================================================================
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   1
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Kidney                                                                        |
 |     Mineralization                                                           |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         1/100 (1%)          3/100 (3%)               |
 |ADJUSTED (b)           |          1.1%                3.2%                    |
 |TERMINAL (d)           |         0/88 (0%)           3/94 (3%)                |
 |FIRST INCIDENCE (DAYS) |          173                 183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.328                  |
 |INCIDENTAL TUMOR       |                             P=0.265                  |
 |LOGISTIC REGRESSION    |                             P=0.310                  |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.311                  |
 |==============================================================================|
 |                                                                              |
 |Kidney                                                                        |
 |     Nephropathy                                                              |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |        24/100 (24%)        25/100 (25%)              |
 |ADJUSTED (b)           |         26.6%               26.0%                    |
 |TERMINAL (d)           |        22/88 (25%)         23/94 (24%)               |
 |FIRST INCIDENCE (DAYS) |          113                 162                     |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.530N                 |
 |INCIDENTAL TUMOR       |                             P=0.510                  |
 |LOGISTIC REGRESSION    |                             P=0.517                  |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.500                  |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   2
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Liver                                                                         |
 |     Angiectasis                                                              |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         6/98 (6%)           3/100 (3%)               |
 |ADJUSTED (b)           |          6.8%                3.2%                    |
 |TERMINAL (d)           |         6/88 (7%)           3/94 (3%)                |
 |FIRST INCIDENCE (DAYS) |          183 (T)             183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.217N                 |
 |INCIDENTAL TUMOR       |                             P=0.217N                 |
 |LOGISTIC REGRESSION    |                             P=0.217N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.239N                 |
 |==============================================================================|
 |                                                                              |
 |Liver                                                                         |
 |     Basophilic Focus                                                         |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         4/98 (4%)           7/100 (7%)               |
 |ADJUSTED (b)           |          4.5%                7.4%                    |
 |TERMINAL (d)           |         4/88 (5%)           7/94 (7%)                |
 |FIRST INCIDENCE (DAYS) |          183 (T)             183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.306                  |
 |INCIDENTAL TUMOR       |                             P=0.306                  |
 |LOGISTIC REGRESSION    |                             P=0.306                  |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.280                  |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   3
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Liver                                                                         |
 |     Clear Cell Focus                                                         |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         8/98 (8%)           5/100 (5%)               |
 |ADJUSTED (b)           |          9.1%                5.3%                    |
 |TERMINAL (d)           |         8/88 (9%)           5/94 (5%)                |
 |FIRST INCIDENCE (DAYS) |          183 (T)             183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.243N                 |
 |INCIDENTAL TUMOR       |                             P=0.243N                 |
 |LOGISTIC REGRESSION    |                             P=0.243N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.271N                 |
 |==============================================================================|
 |                                                                              |
 |Liver                                                                         |
 |     Hematopoietic Cell Proliferation                                         |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         7/98 (7%)           4/100 (4%)               |
 |ADJUSTED (b)           |          7.8%                4.3%                    |
 |TERMINAL (d)           |         6/88 (7%)           4/94 (4%)                |
 |FIRST INCIDENCE (DAYS) |          176                 183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.234N                 |
 |INCIDENTAL TUMOR       |                             P=0.260N                 |
 |LOGISTIC REGRESSION    |                             P=0.244N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.257N                 |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   4
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Liver: Centrilobular                                                          |
 |     Necrosis                                                                 |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         4/98 (4%)           1/100 (1%)               |
 |ADJUSTED (b)           |          4.2%                1.0%                    |
 |TERMINAL (d)           |         1/88 (1%)           0/94 (0%)                |
 |FIRST INCIDENCE (DAYS) |          135                 162                     |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.174N                 |
 |INCIDENTAL TUMOR       |                             P=0.303N                 |
 |LOGISTIC REGRESSION    |                             P=0.072N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.178N                 |
 |==============================================================================|
 |                                                                              |
 |Lung                                                                          |
 |     Thrombosis                                                               |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         1/98 (1%)           2/100 (2%)               |
 |ADJUSTED (b)           |          1.0%                2.1%                    |
 |TERMINAL (d)           |         0/88 (0%)           1/94 (1%)                |
 |FIRST INCIDENCE (DAYS) |          135                 162                     |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.515                  |
 |INCIDENTAL TUMOR       |                             P=0.389                  |
 |LOGISTIC REGRESSION    |                             P=0.518                  |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.508                  |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   5
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Lung: Alveolar Epithelium                                                     |
 |     Hyperplasia                                                              |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |        21/98 (21%)         10/100 (10%)              |
 |ADJUSTED (b)           |         23.9%               10.6%                    |
 |TERMINAL (d)           |        21/88 (24%)         10/94 (11%)               |
 |FIRST INCIDENCE (DAYS) |          183 (T)             183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.015N*                |
 |INCIDENTAL TUMOR       |                             P=0.015N*                |
 |LOGISTIC REGRESSION    |                             P=0.015N*                |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.021N*                |
 |==============================================================================|
 |                                                                              |
 |Lung: Alveolus                                                                |
 |     Infiltration Cellular Histiocyte                                         |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |        21/98 (21%)         15/100 (15%)              |
 |ADJUSTED (b)           |         22.6%               15.8%                    |
 |TERMINAL (d)           |        17/88 (19%)         14/94 (15%)               |
 |FIRST INCIDENCE (DAYS) |           89                 162                     |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.137N                 |
 |INCIDENTAL TUMOR       |                             P=0.189N                 |
 |LOGISTIC REGRESSION    |                             P=0.167N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.162N                 |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   6
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Mammary Gland                                                                 |
 |     Galactocele                                                              |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         0/100 (0%)          3/100 (3%)               |
 |ADJUSTED (b)           |          0.0%                3.2%                    |
 |TERMINAL (d)           |         0/88 (0%)           3/94 (3%)                |
 |FIRST INCIDENCE (DAYS) |          ---                 183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.135                  |
 |INCIDENTAL TUMOR       |                             P=0.135                  |
 |LOGISTIC REGRESSION    |                             P=0.135                  |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.123                  |
 |==============================================================================|
 |                                                                              |
 |Skin                                                                          |
 |     Cyst Epithelial Inclusion                                                |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         6/19 (32%)          1/10 (10%)               |
 |ADJUSTED (b)           |         31.6%               10.0%                    |
 |TERMINAL (d)           |         6/19 (32%)          1/10 (10%)               |
 |FIRST INCIDENCE (DAYS) |          183 (T)             183 (T)                 |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.206N                 |
 |INCIDENTAL TUMOR       |                             P=0.206N                 |
 |LOGISTIC REGRESSION    |                             P=0.206N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.206N                 |
 |==============================================================================|
 

         DATE: 12/18/97                     EXPERIMENT: 89029 TEST: 11                                                 PAGE   7
 STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN FEMALE RATS(SPRAGUE-DAWLEY) -- A  MAGNETIC FIELDS + DMBA INITIATION PRO
                        TERMINAL SACRIFICE AT 27 WEEKS
 |==============================================================================|
 |DOSE                   |          10 DMBA             60 HZ/1G                |
 |                       |          CONTROL             10 DMBA                 |
 |==============================================================================|
 |                                                                              |
 |Skin                                                                          |
 |     Hyperplasia Basal Cell                                                   |
 |                                                                              |
 |------------------------------------------------------------------------------|
 |LESION RATES           |                                                      |
 |-----------            |                                                      |
 |OVERALL (a)            |         6/19 (32%)          0/10 (0%)                |
 |ADJUSTED (b)           |         31.6%                0.0%                    |
 |TERMINAL (d)           |         6/19 (32%)          0/10 (0%)                |
 |FIRST INCIDENCE (DAYS) |          183 (T)             ---                     |
 |-----------------------|                                                      |
 |STATISTICAL TESTS (f)  |                                                      |
 |-----------------------|                                                      |
 |LIFE TABLE             |                             P=0.069N                 |
 |INCIDENTAL TUMOR       |                             P=0.069N                 |
 |LOGISTIC REGRESSION    |                             P=0.069N                 |
 |COCHRAN-ARMITAGE       |                                                      |
 |FISHER EXACT           |                             P=0.057N                 |
 |==============================================================================|
  (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).