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TDMS Study 05197-11 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 02/16/98       
EXPERIMENT: 05197 TEST: 11                                                                                     TIME: 13:20:45       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D       
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 111-76-0002     
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           2 YEAR CHRONIC                                                           
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 02/16/98      
EXPERIMENT: 05197 TEST: 11                                                                                     TIME: 13:20:45      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D      
PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 111-76-0002    
                                  2-BUTOXYETHANOL

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      354   520   521   529   558   558   563   564   565   568                 |
 |      597   609   610   617   631   638   641   642   646   648                 |
 |      648   649   673   683   687   687   697   702   708   708                 |
 |      718                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 31.2 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 39     CENSORED DEATHS 0    TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      465   479   529   533   533   536   544   561   575   576                 |
 |      579   592   610   617   617   620   627   630   633   638                 |
 |      646   649   652   652   652   659   664   666   674   677                 |
 |      688   693   702   704   704   716   722   723   723                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 62.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      340   370   387   461   472   484   542   549   561   565                 |
 |      584   612   617   622   627   644   658   666   666   673                 |
 |      677   687   694   701   703   708   708   716   718                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  2-BUTOXYETHANOL

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 125 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   481   495   508   517   519   534   575   576   589                 |
 |      611   617   628   638   647   652   654   659   666   690                 |
 |      694   695   703   708   718   723                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  2-BUTOXYETHANOL

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.0  98.0  98.0  92.0  78.0  56.0  38.0      |
 |           |                                                                    |
 |           |                                                                    |
 |31.2 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  86.0  76.0  46.0  22.0      |
 |           |                                                                    |
 |           |                                                                    |
 |62.5 PPM   |   100.0 100.0 100.0  98.0  94.0  88.0  86.0  78.0  66.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 |125 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  86.0  80.0  64.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      31.2 PPM     62.5 PPM     125 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       38.0%        22.0%        42.0%        48.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.115N     P=0.196      P=0.772N     P=0.393N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       617.4        627.2        600.4        613.1    |
 |NATURAL DEATHS (C)      |       (13.8)       (10.9)       (20.4)       (16.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       659.8        649.6        654.4        668.7    |
 |(STANDARD ERROR)        |       (11.5)       (10.4)       (14.8)       (11.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                  2-BUTOXYETHANOL

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      400   508   533   554   558   575   594   617   617   638                 |
 |      648   652   654   687   688   708   710   718   718   718                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 31.2 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      495   544   553   561   564   584   606   610   617   638                 |
 |      652   652   655   666   667   687   691   701   707   708                 |
 |      722   722   729                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 62.5 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      247   390   462   462   496   529   544   544   574   583                 |
 |      586   589   619   633   648   649   656   666   688   688                 |
 |      691   694   699   705   708   722   724                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  2-BUTOXYETHANOL

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 125 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      462   472   533   541   571   610   610   612   617   624                 |
 |      638   646   652   662   663   663   666   667   685   689                 |
 |      689   689   694   694   695   701   705   705   729                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  2-BUTOXYETHANOL

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  86.0  74.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |31.2 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  88.0  74.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 |62.5 PPM   |   100.0 100.0  98.0  98.0  96.0  92.0  84.0  76.0  66.0  46.0      |
 |           |                                                                    |
 |           |                                                                    |
 |125 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  90.0  68.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      31.2 PPM     62.5 PPM     125 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.0%        54.0%        46.0%        42.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.106      P=0.832      P=0.238      P=0.159  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       629.4        640.5        599.9        640.8    |
 |NATURAL DEATHS (C)      |       (18.6)       (13.8)       (22.0)       (12.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       687.7        688.8        659.7        678.3    |
 |(STANDARD ERROR)        |       (10.5)       ( 8.9)       (15.0)       ( 9.6)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                          2-BUTOXYETHANOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        31.2 PPM         = 2
                                                        62.5 PPM         = 3
                                                        125 PPM          = 4

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

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

      |
      |
  100 + 1                                                     3 1             4   2
      |                                                       3 1 3           4   2 2      1
      |                                                           3   3          3  2 4 4  112
      |                                                                          3 3    44  1   1
   90 +                                                                            3 3   4 4
      |                                                                              3     4 22 11
      |                                                                                      423 2 2
      |                                                                                          114  4
P  80 +                                                                                          31 3 41 4
E     |                                                                                            23 21134
R     |                                                                                               2 1114 4
C     |                                                                                                   13144
E  70 +                                                                                                    31144
N     |                                                                                                   22 3 3
T     |                                                                                                    22113 43
      |                                                                                                     22    33 4
S  60 +                                                                                                      22      44
U     |                                                                                                            3 3
R     |                                                                                                       12   113334
V     |                                                                                                             11  44
I  50 +                                                                                                        2 2     3344
V     |                                                                                                              11   4 4
A     |                                                                                                          222  1113
L     |                                                                                                                  3  3
   40 +                                                                                                            2 2  11
      |                                                                                                                  1  1
      |                                                                                                              2 2
      |
   30 +                                                                                                                2 2
      |                                                                                                                  22
      |
      |                                                                                                                   2 2
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 40 obs hidden.
                                                          2-BUTOXYETHANOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        31.2 PPM         = 2
                                                        62.5 PPM         = 3
                                                        125 PPM          = 4

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

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

      |
      |
  100 + 1                                       3                       1        4    2
      |                                         3                     3 1        4 4  2 1     2
      |                                                               3          3 4    1    12212
      |                                                                          3    3       4   4
P  90 +                                                                               3     3   12412    4
E     |                                                                                     3 3    12 1 2
R     |                                                                                       3   3   1 221
C     |                                                                                           3 3     14 1
E  80 +                                                                                                    4 112
N     |                                                                                             3 3      411
T     |                                                                                               3   3 3 41 42  1
      |                                                                                                     3 3
S  70 +                                                                                                           2  1  1
U     |                                                                                                       33 44
R     |                                                                                                        3  3 42 211
V     |                                                                                                             44 22
I  60 +                                                                                                                 211
V     |                                                                                                              33   1 1
A     |                                                                                                              433  2 2
L     |                                                                                                                33
   50 +                                                                                                               443 3
      |
      |                                                                                                                4  3 3
      |                                                                                                                     4
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 30 obs hidden.