National Toxicology Program

National Toxicology Program
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TDMS Study 05043-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/05/94   
EXP: 05043            2,4-DIAMINOPHENOL DIHYDROCHLORIDE        TIME: 17:53:59   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 60026    
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: 17:53:59  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 60026   
CONT: N01CP9561903                                             CAS: 137-09-7   
PATHOLOGIST: S. WYAND                        S. EUSTIS                         

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE 72                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 9    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      380   426   440   456   481   522   524   525   549   569                 |
 |      570   576   587   591   642   647   653   658   659   671                 |
 |      672   681   685   686   702   720   721                                   |
 |  CENSORED DEATHS                                                               |
 |      454   454   454   454   454   454   454   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .0125 G/KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 12   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      291   360   435   450   454   461   463   467   482   488                 |
 |      503   561   568   581   597   604   608   611   639   639                 |
 |      648   653   672   681   686   687   708                                   |
 |  CENSORED DEATHS                                                               |
 |      147   286   454   454   454   454   456   456   456   456                 |
 |      456   456                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .025G/KG72                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 34     CENSORED DEATHS 10   TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      327   360   433   462   468   475   489   492   492   506                 |
 |      510   512   512   541   546   561   562   575   588   595                 |
 |      610   632   644   648   653   653   667   677   680   694                 |
 |      715   725   725   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      454   454   454   454   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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 |   100.0 100.0 100.0 100.0  98.3  91.1  85.2  73.3  63.4  47.5      |
 |           |                                                                    |
 |           |                                                                    |
 |.0125      |   100.0 100.0 100.0  96.6  96.6  82.9  78.6  68.0  55.3  44.6      |
 |G/KG 72    |                                                                    |
 |           |                                                                    |
 |.025G/KG72 |   100.0 100.0 100.0  96.7  96.7  88.9  72.8  60.6  48.5  32.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 72       .0125            .025G/KG72    |
 |                                                 G/KG 72                        |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       47.5%            44.6%            32.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.120          P=0.667          P=0.125       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       592.3            555.4            572.3         |
 |NATURAL DEATHS (C)      |       (18.7)           (21.1)           (18.0)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.3            588.2            594.6         |
 |(STANDARD ERROR)        |       (15.0)           (18.6)           (15.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       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                                                             |
 |      193   199   245   246   421   481   536   604   627   667                 |
 |      668   680   680   682   704   708   709   709   711   717                 |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   452   452   452   452   452   452   452                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = .0125 G/KG 72                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      342   422   434   443   480   498   540   568   610   617                 |
 |      620   625   653   690   694   704   714   716                             |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   452   452   452   452   452                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .025G/KG 72                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 11   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   411   498   526   570   571   645   645   653   669                 |
 |      676   681   687   688   695   703   711   723                             |
 |  CENSORED DEATHS                                                               |
 |      282   450   450   450   450   450   450   450   452   452                 |
 |      452                                                                       |
 |                                                                                |
 ==================================================================================

                         2,4-DIAMINOPHENOL DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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  93.3  93.3  91.7  89.6  87.6  85.6  83.5  61.1      |
 |           |                                                                    |
 |           |                                                                    |
 |.0125      |   100.0 100.0 100.0  98.3  96.7  91.3  87.2  85.2  75.1  64.9      |
 |G/KG 72    |                                                                    |
 |           |                                                                    |
 |.025G/KG 72|   100.0 100.0 100.0 100.0  96.6  96.6  92.5  88.4  82.2  63.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE 72       .0125            .025G/KG 72   |
 |                                                 G/KG 72                        |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.1%            64.9%            63.7%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.772N         P=0.871N         P=0.843N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       559.4            576.1            618.4         |
 |NATURAL DEATHS (C)      |       (42.8)           (27.3)           (24.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.2            636.8            642.0         |
 |(STANDARD ERROR)        |       (19.9)           (16.0)           (16.1)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        .0125 G/KG 72    = 2
                                                        .025G/KG72       = 3

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

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

      |
      |
  100 + 1                                             2     3        1
      |                                               2     3    2   1     131
      |                                                                     31  21
      |                                                                         213 1
   90 +                                                                          22313     1
      |                                                                              33
P     |                                                                           2 2      1   1
E     |                                                                             223 3      1  1
R  80 +                                                                              2 233        11
C     |                                                                                2         2211
E     |                                                                                  3    3   221 1
N     |                                                                                            2  12     11
T  70 +                                                                                       3  3     22     11
      |                                                                                          3 3
S     |                                                                                            33   22   2 1 1
U     |                                                                                             3 3          11
R  60 +                                                                                               3  3   22   1 1
V     |                                                                                                  3  3322
I     |                                                                                                      332  2
V     |                                                                                                       33  2 1  1 1
A  50 +                                                                                                             22
L     |                                                                                                        3  33 2  21  1
      |                                                                                                            33   2   2
      |                                                                                                             3 3
   40 +                                                                                                               3  3
      |                                                                                                                  33
      |
      |                                                                                                                   3 3
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 20 obs hidden.

                                                 2,4-DIAMINOPHENOL DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE 72       = 1
                                                        .0125 G/KG 72    = 2
                                                        .025G/KG 72      = 3

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

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

      |
      |
  100 + 1                              1                      2      3
      |                                11                     2      3   3 2
      |
      |                                 1      1                         3 22          3
   95 +                                        11                           2 2        3    3
      |                                         1                          1  2     2
      |                                                                                     3     3
      |                                                                    1        1  2
P  90 +                                                                             1        1
E     |                                                                                2      2   3           3
R     |                                                                                      12   2     1
C     |
E  85 +                                                                                           2     12 1
N     |                                                                                                  221  33  1
T     |                                                                                                        3  3
      |
S  80 +                                                                                                           131
U     |                                                                                                   22
R     |                                                                                                    2   2   33
V     |                                                                                                             33
I  75 +                                                                                                        2     2
V     |                                                                                                             1  1
A     |                                                                                                              22
L     |                                                                                                               211
   70 +                                                                                                               33
      |                                                                                                                22
      |                                                                                                                322
      |                                                                                                                 3 3
   65 +                                                                                                                  2  2
      |                                                                                                                 113 3
      |
      |                                                                                                                  1  1
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

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