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TDMS Study 88070-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                        ISOBUTENE                                       DATE: 06/11/97       
EXPERIMENT: 88070 TEST: 03                                                                                     TIME: 11:17:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15313                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C88070       
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 115-11-0007     
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                        ISOBUTENE                                       DATE: 06/11/97      
EXPERIMENT: 88070 TEST: 03                                                                                     TIME: 11:17:04      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-15313                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C88070      
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 115-11-0007    
                                     ISOBUTENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   467   476   477   495   516   539   539   540   544                 |
 |      552   560   574   576   580   580   590   614   616   621                 |
 |      628   633   636   639   645   648   650   661   666   670                 |
 |      678   681   683   683   684   691   692   705   706   706                 |
 |      719   719   720                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 45     CENSORED DEATHS 0    TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      244   389   460   469   482   507   514   523   526   526                 |
 |      527   537   547   552   560   579   583   583   592   604                 |
 |      607   614   624   625   626   627   632   641   642   660                 |
 |      662   664   664   670   671   671   678   684   684   684                 |
 |      692   692   702   706   716                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 44     CENSORED DEATHS 0    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      352   453   480   496   497   500   512   516   520   520                 |
 |      551   552   555   558   565   568   574   579   580   583                 |
 |      585   590   607   614   614   614   620   627   628   628                 |
 |      650   652   654   654   671   678   680   700   701   705                 |
 |      706   706   714   714                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     ISOBUTENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 8000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 42     CENSORED DEATHS 0    TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      490   505   525   534   534   540   560   576   583   604                 |
 |      604   607   608   610   611   618   631   636   636   647                 |
 |      648   650   650   658   664   664   664   666   667   670                 |
 |      678   688   688   688   689   690   692   700   701   701                 |
 |      702   720                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     ISOBUTENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  92.0  80.0  66.0  44.0  14.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0  98.0  98.0  96.0  90.0  76.0  60.0  34.0  10.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0  98.0  98.0  94.0  80.0  56.0  32.0  12.0      |
 |           |                                                                    |
 |           |                                                                    |
 |8000 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  88.0  78.0  46.0  16.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      2000 PPM     8000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       14.0%        10.0%        12.0%        16.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.282N     P=0.346      P=0.450      P=0.718N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       613.4        596.5        596.0        633.3    |
 |NATURAL DEATHS (C)      |       (12.4)       (14.0)       (12.2)       ( 9.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       630.2        610.1        612.4        649.2    |
 |(STANDARD ERROR)        |       (12.2)       (13.9)       (12.4)       ( 9.3)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      390   421   440   488   488   496   529   552   552   573                 |
 |      581   608   642   642   648   663   664   678   691   705                 |
 |      705   714   715   720   720   722   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 1    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      216   420   440   455   479   494   496   534   534   548                 |
 |      565   573   580   603   608   621   630   635   662   664                 |
 |      688   688   692   701   708   714   716   718   719   722                 |
 |  CENSORED DEATHS                                                               |
 |      13                                                                        |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      399   522   534   552   560   607   620   626   644   651                 |
 |      680   684   686   701   705   706   720                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     ISOBUTENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 8000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     407   469   500   511   512   547   559   580   592                 |
 |      597   628   630   642   650   657   663   664   668   671                 |
 |      674   681   692   702   706   720   720   729                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     ISOBUTENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  96.0  94.0  86.0  78.0  66.0  46.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0  98.0  98.0  95.9  89.8  81.6  71.4  59.2  38.8      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  90.0  80.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |8000 PPM   |    98.0  98.0  98.0  98.0  96.0  94.0  88.0  78.0  64.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      2000 PPM     8000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       46.0%        38.8%        66.0%        44.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.926      P=0.469      P=0.069N     P=0.909  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       610.1        594.1        623.4        599.1    |
 |NATURAL DEATHS (C)      |       (20.0)       (21.5)       (20.9)       (27.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       666.6        635.3        695.7        658.0    |
 |(STANDARD ERROR)        |       (13.8)       (20.4)       (10.2)       (17.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                             ISOBUTENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        2000 PPM         = 3
                                                        8000 PPM         = 4

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

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

      |
      |
  112 +
      |
      |
      | 1                                      2                3    12         3 1  4  4
   96 +                                                               2         32111 3 4  4 4
      |                                                                           2 1 1321   44
P     |                                                                                321 2 14 4  4
E     |                                                                                  3 2211    44   4
R  80 +                                                                                    322111
C     |                                                                                      2 21 11    44
E     |                                                                                        22332     44
N     |                                                                                           312 1  14 4
T  64 +                                                                                            32 2 211 4 4
      |                                                                                             3 3 22111
S     |                                                                                               3 32 21144
U     |                                                                                                      114 4
R  48 +                                                                                                  332221  14
V     |                                                                                                      2   11
I     |                                                                                                    3  33  1114
V     |                                                                                                          22
A  32 +                                                                                                        3  3311
L     |                                                                                                           222131
      |                                                                                                               33
      |                                                                                                             22 1 1
   16 +                                                                                                              2 231  1
      |                                                                                                                232  2
      |
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 65 obs hidden.
                                                             ISOBUTENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        2000 PPM         = 3
                                                        8000 PPM         = 4

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

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

      |
      |
  100 + 14                                2                           13
      |  4                                2                           13 421               3
      |                                                                  421 1  2 4  1 4   3 3 3
      |                                                                         2   2  44      33
   90 +                                                                             211 44      3       3
      |                                                                               1  4  1  4        3 3
P     |                                                                               2     12 14  4      33 3
E     |                                                                                      2 1  14  4      33
R  80 +                                                                                        2 211  44      3     3
C     |                                                                                          221   41  4
E     |                                                                                           22    1  4 1      3  3
N     |                                                                                            2    2    11
T  70 +                                                                                                 2 2   14 1
      |                                                                                                   22   4 4     3 3
S     |                                                                                                    22    141 1   3  3
U     |                                                                                                     2    2   1 1
R  60 +                                                                                                          244 2
V     |                                                                                                            44  11
I     |                                                                                                             44 411
V     |                                                                                                              2 2
A  50 +                                                                                                                2211
L     |                                                                                                                 22
      |                                                                                                                  41 1
      |
   40 +                                                                                                                  22 2
      |
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 25 obs hidden.