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TDMS Study 05155-03 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 05/08/95   
EXP: 05155                   P-NITROBENZOIC ACID               TIME: 17:37:59   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 61778B   
CONT: N01-ES-85217                                             CAS: 62-23-7     
PATHOLOGIST: DR D. FARNELL                   HAILEY, JAMES R.                   
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REASONS FOR REMOVAL:                                                            
                                                                                
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 05/08/95  
EXP: 05155                   P-NITROBENZOIC ACID               TIME: 17:37:59  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 61778B  
CONT: N01-ES-85217                                             CAS: 62-23-7    
PATHOLOGIST: DR D. FARNELL                   HAILEY, JAMES R.                  

                                P-NITROBENZOIC ACID


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 38     CENSORED DEATHS 10   TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      246   299   381   392   419   438   451   503   505   517                 |
 |      535   541   547   548   556   556   561   584   588   602                 |
 |      617   617   631   645   645   668   673   673   674   680                 |
 |      680   689   689   702   710   714   722   724                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 37     CENSORED DEATHS 10   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      310   392   415   454   493   505   527   532   532   538                 |
 |      539   561   584   587   588   591   602   624   631   637                 |
 |      647   652   665   673   673   673   674   674   700   700                 |
 |      702   702   710   722   722   728   728                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 37     CENSORED DEATHS 10   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      426   505   506   506   506   517   532   541   556   568                 |
 |      570   573   588   604   604   609   631   632   643   651                 |
 |      657   668   672   673   674   674   679   679   687   696                 |
 |      700   702   702   709   722   728   728                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                P-NITROBENZOIC ACID


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      191   434   445   458   483   506   506   518   532   542                 |
 |      548   567   608   615   617   618   647   654   681   689                 |
 |      694   695   696   700   703   710   710   719   720                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                P-NITROBENZOIC ACID


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0  98.3  96.7  91.7  88.3  78.1  61.6  51.4  24.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0  98.3  95.0  93.3  79.1  67.0  54.8  26.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0 100.0  98.3  84.3  70.2  58.2  26.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0  98.3  98.3  98.3  91.0  80.9  76.8  64.7  42.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0.0%         0.125%       0.25%        0.5%     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       24.7%        26.4%        26.1%        42.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.038N     P=0.651N     P=0.563N     P=0.053N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       576.9        605.1        622.1        593.3    |
 |NATURAL DEATHS (C)      |       (19.5)       (16.9)       (12.9)       (22.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       587.2        607.1        617.6        617.9    |
 |(STANDARD ERROR)        |       (16.4)       (15.1)       (13.5)       (16.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                P-NITROBENZOIC ACID


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      490   556   566   605   631   647   653   657   664   667                 |
 |      679   679   680   687   694   700   700   702   702   709                 |
 |      714   722   724                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      150   441   483   496   510   521   548   566   570   632                 |
 |      651   665   674   674   674   676   694   695   696   696                 |
 |      696   696   700   702   702   708   728                                   |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      241   379   379   434   461   492   496   499   518   538                 |
 |      553   588   604   643   647   647   650   653   664   668                 |
 |      685   694   695   695   702   702   708   709   714                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                P-NITROBENZOIC ACID


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   483   493   518   528   532   541   556   565   574                 |
 |      602   611   618   622   674   687   689   695   695   700                 |
 |      702   702   707   708   708   709   709   714   714                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                P-NITROBENZOIC ACID


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0  98.3  98.3  98.3  98.3  94.7  88.6  82.6  76.5  46.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0  98.3  98.3  95.0  91.3  81.2  75.1  62.9  42.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0 100.0  96.3  86.3  78.3  72.2  42.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0.0%         0.125%       0.25%        0.5%     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       54.0%        46.3%        42.6%        42.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.250      P=0.400      P=0.137      P=0.231  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       662.1        616.4        588.2        627.5    |
 |NATURAL DEATHS (C)      |       (12.2)       (24.1)       (22.9)       (16.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       658.5        633.4        616.0        635.0    |
 |(STANDARD ERROR)        |       (13.2)       (16.3)       (16.6)       (14.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                        P-NITROBENZOIC ACID
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.125%           = 2
                                                        0.25%            = 3
                                                        0.5%             = 4

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

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

      |
      |
  100 + 1                              4        1         2                3
      |                                4        1      1  2          12   234 4         3
      |                                                              11   2   4 24
      |                                                               1   1  1  24  4 2 2
   90 +                                                                      1  1   4   23  2
      |                                                                         1      113  3 3
      |                                                                                 11  4 3 3
      |                                                                                  1  214 3 3
P  80 +                                                                                      114 2
E     |                                                                                       11 23 2   4
R     |                                                                                        11   3   34
C     |                                                                                                  44
E  70 +                                                                                         11  2 22
N     |                                                                                          1  1  23 423 44
T     |                                                                                                    223 4    4
      |                                                                                             1  1  1  33     44
S  60 +                                                                                                     2 22     44
U     |                                                                                                   1 1  2 23
R     |                                                                                                     1 1  232
V     |                                                                                                       1   1   44
I  50 +                                                                                                           11   44
V     |                                                                                                                 44
A     |                                                                                                            2 32
L     |                                                                                                            1133  4  4
   40 +                                                                                                             1122
      |                                                                                                               322
      |                                                                                                              1 12 2
      |                                                                                                                11 3
   30 +                                                                                                                 1 1
      |                                                                                                                   2 2
      |                                                                                                                   1 1
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 40 obs hidden.

                                                        P-NITROBENZOIC ACID
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.125%           = 2
                                                        0.25%            = 3
                                                        0.5%             = 4

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

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

      |
      |
  100 + 1                       2              3                             4       1
      |                         2              3                     3       2      214         1
      |                                                              3      3       2 2  4      11      1
      |                                                                     3    3    2 24  4           1   1
P  90 +                                                                                 2  2                1 1
E     |                                                                               33   24 4242            11
R     |                                                                                3 3      422            1 1
C     |                                                                                  3   3   42         2    11
E  80 +                                                                                      3 3  4 3  4    2 2   11
N     |                                                                                             3  4344   2  2 2
T     |                                                                                                 3    3     111
      |                                                                                                   4  33    4 11
S  70 +                                                                                                            4 4
U     |                                                                                                       33   2  2
R     |                                                                                                        3 3   411
V     |                                                                                                          33    11
I  60 +                                                                                                           3 3 34
V     |                                                                                                                 1 1
A     |                                                                                                               224 1 1
L     |                                                                                                               33
   50 +                                                                                                                22
      |                                                                                                                32 2 2
      |
      |                                                                                                                 3   3
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 27 obs hidden.