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TDMS Study 05210-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: I. I. T. Research Inst                                   ETHYLBENZENE                                     DATE: 04/23/96       
EXPERIMENT: 05210 TEST: 04                                                                                     TIME: 10:28:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75193                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 56393        
PATHOLOGIST: TOMLINSON, MIK                                                                                    CAS: 100-41-4        
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                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: I. I. T. Research Inst                                   ETHYLBENZENE                                     DATE: 04/23/96      
EXPERIMENT: 05210 TEST: 04                                                                                     TIME: 10:28:20      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-75193                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 56393       
PATHOLOGIST: TOMLINSON, MIK                                                                                    CAS: 100-41-4       
                                   ETHYLBENZENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 1    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      29    202   289   467   519   522   544   555   568   584                 |
 |      585   587   610   610   616   639   642   652   698   723                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      24                                                                        |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      360   380   485   514   531   536   578   580   594   640                 |
 |      641   677   709   725                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      480   524   563   570   574   579   579   588   602   642                 |
 |      680   683   688   691   696   705   722   724                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      259   418   430   480   520   565   582   607   618   632                 |
 |      647   659   659   660   669   679   679   708   725                       |
 |  CENSORED DEATHS                                                               |
 |      179                                                                       |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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    |    98.0  98.0  95.9  93.9  93.9  91.8  85.7  75.5  63.3  57.1      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0  98.0  96.0  94.0  88.0  82.0  78.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |250     PPM|   100.0 100.0 100.0 100.0 100.0  98.0  96.0  82.0  80.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |750     PPM|   100.0 100.0  98.0  98.0  95.9  91.8  89.8  85.7  71.4  61.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      75 PPM       250     PPM  750     P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.1%        72.0%        64.0%        61.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.975      P=0.177N     P=0.459N     P=0.673N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       541.2        567.9        627.2        589.3    |
 |NATURAL DEATHS (C)      |       (37.6)       (29.5)       (17.4)       (27.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       636.0        683.9        692.4        664.9    |
 |(STANDARD ERROR)        |       (23.9)       (13.1)       ( 9.3)       (17.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   501   565   578   592   597   618   629   639   688                 |
 |      694   715   718   725                                                     |
 |  CENSORED DEATHS                                                               |
 |      215                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      300   495   562   584   590   602   639   642   697   697                 |
 |      703   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 1    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      437   446   659   682   694   701   705   707   708                       |
 |  CENSORED DEATHS                                                               |
 |      86                                                                        |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      7     169   568   612   614   666   681   711   712   712                 |
 |      713   718   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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  95.9  87.8  81.6  71.4      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  88.0  84.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |250     PPM|   100.0 100.0 100.0 100.0 100.0  95.9  95.9  95.9  93.9  81.6      |
 |           |                                                                    |
 |           |                                                                    |
 |750     PPM|    98.0  96.0  96.0  96.0  96.0  96.0  96.0  94.0  90.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      75 PPM       250     PPM  750     P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       71.4%        76.0%        81.6%        74.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.995N     P=0.762N     P=0.304N     P=0.886N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.1        602.8        637.7        585.1    |
 |NATURAL DEATHS (C)      |       (23.4)       (33.8)       (37.4)       (63.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       688.9        699.5        700.5        692.3    |
 |(STANDARD ERROR)        |       (13.5)       (11.0)       (15.0)       (18.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1     1                                  4               2                  3
      |
      |       1                         1        4               2   2    4         3      3
      |                                 1             1              2    4 4        2     3     3
   95 +
      |                                               1                     4     1 42   2       33
      |                                                                                  2  2
      |                                                                           1 4      1
   90 +                                                                                    422   433
      |
P     |                                                                                    1 21  4 24
E     |                                                                                       1 1  33   4
R  85 +
C     |                                                                                         1 123 234 4
E     |                                                                                               23     2
N     |                                                                                           1 1     4 4
T  80 +                                                                                                     434     3
      |
S     |                                                                                                      24  4 2
U     |                                                                                                            233  2
R  75 +                                                                                             1    1
V     |                                                                                                                 2 2
I     |                                                                                                              33   2 2
V     |                                                                                                          44
A  70 +                                                                                                  1   1    44  33
L     |
      |                                                                                                                3  3
      |
   65 +                                                                                                      1 1   4    4
      |                                                                                                        1      1 4 3 3
      |
      |                                                                                                               1   1 4
   60 +
      |
      |                                                                                                                   1 1
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.
                                                            ETHYLBENZENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        75 PPM           = 2
                                                        250     PPM      = 3
                                                        750     PPM      = 4

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 14                                             2                   1 3
      |
      |  4                          4                  2                   1 33       21
      |                             4                                         3       21         14              3
P  95 +
E     |                                                                                          1412    4       3  3
R     |                                                                                             2 2
C     |                                                                                            1  1             3 3
E  90 +                                                                                               11 4        4   33
N     |
T     |                                                                                                1  1  2    4 4
      |                                                                                                   11        4   4
S  85 +
U     |                                                                                                    1 1        233
R     |
V     |                                                                                                      1       1  3   3
I  80 +                                                                                                              112
V     |
A     |                                                                                                               12412
L     |                                                                                                                  42 2
   75 +
      |                                                                                                                  11 4
      |
      |                                                                                                                   1 1
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 13 obs hidden.