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TDMS Study 05172-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: HLA, VA                                                   DATE: 09/18/94   
EXP: 05172          3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE     TIME: 06:47:03   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 99989    
CONT: NO1ES9565503                                             CAS: 20325400    
PATHOLOGIST: B. ULLAND                                                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: HLA, VA                                                   DATE: 09/18/94  
EXP: 05172          3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE     TIME: 06:47:03  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 99989   
CONT: NO1ES9565503                                             CAS: 20325400   
PATHOLOGIST: B. ULLAND                                                         

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 647 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      73    452   505   529   531   573   581   603   603   616                 |
 |      629   640   644   645   645   646                                         |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 80 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      262   353   354   480   480   483   485   515   538   546                 |
 |      552   556   556   558   578   585   588   593   595   596                 |
 |      596   602   603   603   604   606   609   610   611   618                 |
 |      618   618   618   638   641   644   644                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 170 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 75     CENSORED DEATHS 0    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      284   304   333   339   358   391   391   408   417   420                 |
 |      424   424   437   458   467   472   472   476   483   483                 |
 |      483   485   485   485   485   486   486   506   508   514                 |
 |      525   526   531   533   535   536   538   539   541   546                 |
 |      546   546   553   555   556   556   556   556   557   560                 |
 |      560   561   561   561   561   561   562   562   562   578                 |
 |      578   581   591   594   596   603   604   616   616   616                 |
 |      616   632   634   641   644                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 647 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 330 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 60     CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      267   284   304   332   337   339   344   401   401   402                 |
 |      414   419   423   423   423   424   425   441   445   476                 |
 |      477   478   483   483   483   485   485   486   486   490                 |
 |      506   511   512   521   525   527   534   536   537   541                 |
 |      542   542   546   546   550   550   550   551   560   560                 |
 |      560   560   560   560   561   585   590   592   595   597                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 ==================================================================================

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 647 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   647 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.6  98.6  98.6  98.6  98.6  96.9  91.9  85.2  73.5  73.5      |
 |           |                                                                    |
 |           |                                                                    |
 |80 PPM     |   100.0 100.0  97.8  93.3  93.3  84.4  80.0  44.4  17.8  17.8      |
 |           |                                                                    |
 |           |                                                                    |
 |170 PPM    |   100.0 100.0 100.0  93.3  84.0  66.7  48.0  10.7   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 |330 PPM    |   100.0 100.0  98.6  88.5  71.8  55.1  30.1   0.0   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      80 PPM       170 PPM      330 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       73.5%        17.8%         0.0%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       557.2        560.4        517.9        484.5    |
 |NATURAL DEATHS (C)      |       (35.4)       (14.1)       ( 9.3)       (10.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       573.3        575.8        517.9        454.5    |
 |(STANDARD ERROR)        |       (17.2)       (12.6)       ( 9.3)       (12.7)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 648 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      402   528   532   543   574   578   590   599   600   602                 |
 |      618   624   624   631   644                                               |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 80 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      373   424   424   436   476   483   485   485   505   512                 |
 |      520   562   564   571   573   588   599   599   602   606                 |
 |      616   616   616   618   618   618   618   618   632   644                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 170 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 69     CENSORED DEATHS 0    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      220   274   287   287   304   304   309   331   333   339                 |
 |      339   339   344   354   358   358   358   361   373   378                 |
 |      378   379   379   408   408   408   419   423   424   424                 |
 |      436   436   436   449   450   450   465   468   476   476                 |
 |      477   483   483   483   483   486   501   505   506   527                 |
 |      533   550   550   550   550   556   561   562   562   563                 |
 |      563   564   571   583   597   602   616   616   641                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 648 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 330 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 60     CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      251   262   270   284   287   304   304   317   339   339                 |
 |      344   344   344   344   344   354   358   363   378   378                 |
 |      395   402   408   408   408   423   424   424   424   424                 |
 |      430   431   431   431   431   436   436   441   450   452                 |
 |      452   465   483   483   483   483   485   485   491   548                 |
 |      560   560   561   563   563   596   602   610   613   613                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 ==================================================================================

                      3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 648 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   648 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  98.3  93.3  83.3  75.0  75.0      |
 |           |                                                                    |
 |           |                                                                    |
 |80 PPM     |   100.0 100.0 100.0 100.0  93.3  82.2  75.6  57.8  33.3  33.3      |
 |           |                                                                    |
 |           |                                                                    |
 |170 PPM    |   100.0 100.0  98.7  76.0  60.0  40.0  32.0  12.0   8.0   8.0      |
 |           |                                                                    |
 |           |                                                                    |
 |330 PPM    |   100.0 100.0  95.7  70.5  50.4  20.2  18.5   5.0   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      80 PPM       170 PPM      330 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       75.0%        33.3%         8.0%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       579.3        553.4        448.8        428.6    |
 |NATURAL DEATHS (C)      |       (15.7)       (13.7)       (12.0)       (12.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       580.0        584.9        464.7        406.7    |
 |(STANDARD ERROR)        |       (15.7)       (11.3)       (12.7)       (12.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        80 PPM           = 2
                                                        170 PPM          = 3
                                                        330 PPM          = 4

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
  100 +  1            1                                24 3
      |               1                                24 3   3    3  2                1         1
      |                                                       4    33  3                         1  1
      |                                                            44 23    3               2       1      1
   90 +                                                             44      3   33                         1 1
      |                                                              4         4 33         22               1   1
      |                                                                           3  3       2    2              1 1
      |                                                                        4 4   3  33        2  2             1 1 1
   80 +                                                                          44      3 3         2 2
      |                                                                                                22              1 1
      |                                                                                    33           22
      |                                                                           4  4      33                           1
P  70 +                                                                              44                  2   2
E     |                                                                               4    44                22
R     |                                                                                      3   3
C     |                                                                                          33           22
E  60 +                                                                                           33
N     |                                                                                     44     33          22
T     |                                                                                             33
      |
S  50 +                                                                                      4   4   3 3        22
U     |                                                                                          44
R     |                                                                                           44   33
V     |                                                                                            44   33
I  40 +                                                                                             44           2 2
V     |
A     |                                                                                              4 4           22
L     |                                                                                                  33
   30 +
      |                                                                                                44           2  2
      |
      |                                                                                                   3  3
   20 +                                                                                                 44
      |                                                                                                      3 3       2 2
      |                                                                                                        33
      |                                                                                                         33
   10 +                                                                                                  44      3 3
      |                                                                                                   4   44
      |                                                                                                            3  3
      |                                                                                                        44     33
    0 +                                                                                                         4      3
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 15 obs hidden.

                                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        80 PPM           = 2
                                                        170 PPM          = 3
                                                        330 PPM          = 4

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
  100 +  1                                     3    4                     2    1
      |                                        3    4  4433               2    1  2                 1
      |                                                 4 3   3                                     1  1
      |                                                   4   33                  2  2                 1   1 1
   90 +                                                       434  3                 2     22                1 1
      |                                                         4  33                       22                 11
      |                                                             33
      |                                                              333                     2   2              1   11
   80 +                                                                                          22
      |                                                                                           22                 111
      |                                                              443  3                        2      2            1 1
      |                                                                   33
P  70 +                                                                4  43    3                         22
E     |                                                                   4  4                             2  2
R     |                                                                      4 4333                           2 2
C     |
E  60 +                                                                         4 3  3
N     |                                                                                                         22
T     |                                                                              3 3                         2 2
      |                                                                                3 3
S  50 +                                                                           44     3 3                       22
U     |                                                                                    33
R     |
V     |                                                                            4 4
I  40 +                                                                                     33
V     |                                                                              4 4     3 3 3                  2 2
A     |                                                                                          3  3                 22
L     |                                                                                4 4          33  3              2 2
   30 +                                                                                  4  4
      |                                                                                                 33
      |                                                                                                  33
      |                                                                                     44
   20 +                                                                                      44
      |                                                                                       4         4433
      |                                                                                                    3  3 3
      |                                                                                                  44     3  3
   10 +                                                                                                            3   3
      |                                                                                                   4     4      3 3
      |                                                                                                         4  4
      |
    0 +                                                                                                            4
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 25 obs hidden.

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