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TDMS Study 55301-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                                         PYRIDINE                                       DATE: 10/08/97       
EXPERIMENT: 55301 TEST: 05                                                                                     TIME: 11:20:59       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES95268                                ROUTE: DOSED WATER                                             NTP C#: 55301B       
PATHOLOGIST: P. HILDEBRANDT                                                                                    CAS: 110-86-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: TSI Mason Research                                         PYRIDINE                                       DATE: 10/08/97      
EXPERIMENT: 55301 TEST: 05                                                                                     TIME: 11:20:59      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES95268                                ROUTE: DOSED WATER                                             NTP C#: 55301B      
PATHOLOGIST: P. HILDEBRANDT                                                                                    CAS: 110-86-1       
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      309   388   388   434   473   571   574   579   595   602                 |
 |      604   625   640   644   656   667   667   692   695   701                 |
 |      715   718   718   719   719                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   455   466   538   553   598   604   604   607   618                 |
 |      620   625   628   641   642   664   665   665   666   666                 |
 |      666   667   673   677   682   698   700   701   708   718                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      269   486   525   529   534   538   580   585   589   596                 |
 |      609   627   632   640   644   648   648   662   669   673                 |
 |      679   700   700   708   719                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 400 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      194   428   444   465   515   520   523   543   562   584                 |
 |      598   601   616   622   627   634   644   647   647   651                 |
 |      670   672   675   676   681   685   691   691   697   697                 |
 |      700   717   719   719                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   722 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.0  94.0  90.0  90.0  78.0  70.0  50.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0  94.0  92.0  84.0  64.0  40.0      |
 |           |                                                                    |
 |           |                                                                    |
 |200 PPM    |   100.0 100.0  98.0  98.0  98.0  98.0  88.0  80.0  64.0  50.0      |
 |           |                                                                    |
 |           |                                                                    |
 |400 PPM    |   100.0 100.0  98.0  98.0  98.0  92.0  84.0  76.0  60.0  32.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        100 PPM      200 PPM      400 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       50.0%        40.0%        50.0%        32.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.124      P=0.403      P=1.000      P=0.095  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       603.7        628.6        607.6        610.4    |
 |NATURAL DEATHS (C)      |       (23.6)       (13.3)       (19.0)       (18.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       662.9        666.0        664.8        646.1    |
 |(STANDARD ERROR)        |       (14.4)       (10.3)       (12.5)       (14.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                     PYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      399   493   503   588   596   622   636   649   661   667                 |
 |      671   673   681   687   696   717   717   722                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      488   533   546   570   611   642   650   666   666   682                 |
 |      695   717   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      496   521   549   561   573   580   586   605   624   665                 |
 |      671   687   698   699   700   703   707   707   711   718                 |
 |      721                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 400 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      380   457   503   511   583   584   589   603   605   608                 |
 |      616   625   628   634   636   639   641   649   672   673                 |
 |      687   692   705   711                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  90.0  82.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  86.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |200 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  84.0  80.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |400 PPM    |   100.0 100.0 100.0 100.0  98.0  96.0  92.0  82.0  64.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        100 PPM      200 PPM      400 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.0%        74.0%        58.0%        52.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.055      P=0.392N     P=0.700      P=0.204  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       632.1        630.3        642.0        609.6    |
 |NATURAL DEATHS (C)      |       (20.7)       (20.9)       (15.9)       (16.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       694.1        703.3        692.5        671.7    |
 |(STANDARD ERROR)        |       ( 9.9)       ( 8.1)       ( 9.0)       (11.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                              PYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        100 PPM          = 2
                                                        200 PPM          = 3
                                                        400 PPM          = 4

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

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

      |
      |
  100 + 1                              4           3      1                   2
      |                                4           3      1           1     4 2 2    3
      |                                                               1     1 4 2 2  3     332
      |                                                                     1     41     4  32 2
   90 +                                                                            1     4 4   2  1    2
      |                                                                                      3     3   22
P     |                                                                                    4  4  4113 1
E     |                                                                                          4  4 112 2
R  80 +                                                                                             4  11
C     |                                                                                                 1 21
E     |                                                                                                4 44131
N     |                                                                                                   44 1 1
T  70 +                                                                                                    44231 21
      |                                                                                                     44
S     |                                                                                                      43  21  11
U     |                                                                                                           33  11
R  60 +                                                                                                       4   4    1 1
V     |                                                                                                            3  3
I     |                                                                                                           22  3 3
V     |                                                                                                            22   33
A  50 +                                                                                                             2 2  11
L     |                                                                                                             44
      |                                                                                                              4222
      |                                                                                                                 22
   40 +                                                                                                                  22
      |                                                                                                               4  4
      |
      |                                                                                                                  44
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 43 obs hidden.
                                                              PYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        100 PPM          = 2
                                                        200 PPM          = 3
                                                        400 PPM          = 4

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

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

      |
      |
  104 +
      |
      | 1                                                            4 1             23
      |                                                              4 1         4   21    3 2
   96 +                                                                          4    11   3 223
      |                                                                                14     23 32 1
P     |                                                                                 4        32 1  1 2
E     |                                                                                           33   1 21  2
R  88 +                                                                                            33 4   1 122
C     |                                                                                             3 4 3   1 1   2
E     |                                                                                                 3  3  1  1
N     |                                                                                                    3     11 2
T  80 +                                                                                                 44       33 2 2
      |                                                                                                  4 4      11 32  2
S     |                                                                                                            1133  22
U     |                                                                                                    44       11    2 2
R  72 +                                                                                                              11
V     |                                                                                                     44        13 1
I     |
V     |                                                                                                      44          11
A  64 +                                                                                                       4   4    33 1 1
L     |                                                                                                           44    33
      |                                                                                                            4 4
      |                                                                                                                  3  3
   56 +                                                                                                              4 4
      |                                                                                                                44
      |                                                                                                                 4   4
      |
   48 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.