National Toxicology Program

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TDMS Study 05043-02 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/05/94   
EXP: 05043            2,4-DIAMINOPHENOL DIHYDROCHLORIDE        TIME: 19:08:39   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: C60026   
CONT: N01CP9561903                                             CAS: 137-09-7    
PATHOLOGIST: S. WYAND                        S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/05/94  
EXP: 05043            2,4-DIAMINOPHENOL DIHYDROCHLORIDE        TIME: 19:08:39  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: C60026  
CONT: N01CP9561903                                             CAS: 137-09-7   
PATHOLOGIST: S. WYAND                        S. EUSTIS                         

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE 72                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      113   147   157   204   214   328   469   483   483   537                 |
 |      543   563   602   607   621   630   669   670   685   719                 |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .019 G/ KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    102   233   449   483   518   570   571   590   602                 |
 |      607   613   617   617   624   719   721                                   |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .038 G/ KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      136   378   453   470   568   579   603   606   613   621                 |
 |      657   679   688   694                                                     |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 ==================================================================================

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE 72 |   100.0  95.0  91.7  90.0  90.0  83.9  79.8  75.7  69.5  61.4      |
 |           |                                                                    |
 |           |                                                                    |
 |.019       |   100.0  96.7  95.0  95.0  95.0  91.3  89.3  81.2  71.0  67.0      |
 |G/ KG 72   |                                                                    |
 |           |                                                                    |
 |.038       |   100.0  98.3  98.3  98.3  96.7  93.0  93.0  86.9  78.8  72.8      |
 |G/ KG 72   |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 72       .019             .038          |
 |                                                 G/ KG 72         G/ KG 72      |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.4%            67.0%            72.8%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.199N         P=0.610N         P=0.231N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       472.2            513.8            553.2         |
 |NATURAL DEATHS (C)      |       (45.2)           (46.3)           (40.6)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       598.7            623.4            643.3         |
 |(STANDARD ERROR)        |       (22.5)           (20.0)           (16.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE 72                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      321   340   376   400   454   458   542   558   621   656                 |
 |      670   705   710   722   722   726                                         |
 |  CENSORED DEATHS                                                               |
 |      453   453   453   453   453   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .019 G/ KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      71    256   330   330   337   410   471   516   592   619                 |
 |      620   631   660   683   692   700   704   713   726                       |
 |  CENSORED DEATHS                                                               |
 |      453   453   453   453   453   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .038 /G KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      245   288   288   327   327   340   410   430   441   443                 |
 |      479   516   531   592   614   659   661   662   662   667                 |
 |      667   688                                                                 |
 |  CENSORED DEATHS                                                               |
 |      453   453   453   453   453   453   453   453   453   453                 |
 |                                                                                |
 ==================================================================================

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE 72 |   100.0 100.0 100.0  96.7  93.3  89.3  87.2  85.2  81.2  69.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.019       |    98.3  98.3  96.7  91.7  90.0  88.0  85.9  83.9  75.7  63.4      |
 |G/ KG 72   |                                                                    |
 |           |                                                                    |
 |.038       |   100.0 100.0  98.3  90.0  88.3  81.3  77.1  75.0  64.6  58.3      |
 |/G KG 72   |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 72       .019             .038          |
 |                                                 G/ KG 72         /G KG 72      |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       69.0%            63.4%            58.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.174          P=0.603          P=0.208       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       561.3            529.5            497.1         |
 |NATURAL DEATHS (C)      |       (37.4)           (43.6)           (32.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       638.3            619.8            598.0         |
 |(STANDARD ERROR)        |       (17.3)           (20.2)           (19.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE 72       = 1
                                                        .019 G/ KG 72    = 2
                                                        .038 G/ KG 72    = 3

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1              2   1  3
      |                2 2 1  31                                   3
      |
      |                  2     1 1           2                     3            3
   95 +                          1       1   2                                  2  3
      |                                  11                                     2   2
      |                                                                            3              3
      |                                   1                 1                       2    2        33
P  90 +                                                     1                     1
E     |                                                                                  2        23    3
R     |                                                                           1 1
C     |
E  85 +                                                                                           2   2 33
N     |                                                                             1        1        22
T     |                                                                                                  33
      |                                                                                      11        22 3    3
S  80 +                                                                                       1  1
U     |                                                                                                 22     3   3
R     |                                                                                          1     1 22
V     |                                                                                                11          3 3
I  75 +                                                                                                              33
V     |                                                                                                 1 1
A     |                                                                                                   22          3     3
L     |                                                                                                   11             2
   70 +                                                                                                    1      1
      |
      |                                                                                                                  2  2
      |
   65 +                                                                                                           1 1
      |                                                                                                             1    1
      |
      |                                                                                                                  1  1
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.

                                                 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE 72       = 1
                                                        .019 G/ KG 72    = 2
                                                        .038 /G KG 72    = 3

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1           2                          3           1
      |             2                          3 2    3    1  1
      |
      |                                          2           21    1
   95 +                                               3     3      1    1
      |                                                      22         1       1
      |
      |                                                     3 2          2      11
   90 +                                                       3          2         2
      |                                                                  3  3    1            1
P     |                                                                            2     2    1 1
E     |                                                                     33           2            2
R  85 +                                                                      33                 1         1
C     |                                                                       3     3                 2   1    1
E     |
N     |                                                                             3    3                     1  1
T  80 +                                                                                                   2 2
      |                                                                                  3  3                     1    1
S     |                                                                                     3         3     2    2     11
U     |                                                                                                          2  2
R  75 +                                                                                               3  3              1 1
V     |                                                                                                             22
I     |                                                                                                  3       3
V     |                                                                                                              22
A  70 +                                                                                                               22
L     |                                                                                                                   1 1
      |                                                                                                                22
      |
   65 +                                                                                                          33     2 2
      |                                                                                                                   2 2
      |
      |
   60 +                                                                                                           3  3
      |                                                                                                              3      3
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

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