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TDMS Study 05210-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: I. I. T. Research Inst                                   ETHYLBENZENE                                     DATE: 03/14/96       
EXPERIMENT: 05210 TEST: 03                                                                                     TIME: 12:54:34       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75193                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 56393        
PATHOLOGIST: BRENNECKE, LUK                                                                                    CAS: 100-41-4        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             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: 03/14/96      
EXPERIMENT: 05210 TEST: 03                                                                                     TIME: 12:54:34      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-75193                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 56393       
PATHOLOGIST: BRENNECKE, LUK                                                                                    CAS: 100-41-4       
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      354   391   479   497   528   547   553   570   574   584                 |
 |      590   602   608   609   618   623   630   639   640   640                 |
 |      644   652   653   661   668   685   689   689   689   692                 |
 |      710   710   713   714   715                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      244   308   352   416   518   538   549   560   582   584                 |
 |      584   596   600   601   607   615   617   619   626   631                 |
 |      634   637   639   640   654   668   671   692   693   695                 |
 |      707   713   714   718   720   723                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      266   420   467   496   509   527   528   556   589   590                 |
 |      590   591   591   596   619   624   629   643   644   665                 |
 |      668   669   671   671   686   688   696   703   703   703                 |
 |      704   707   708   712   713   720   723                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 48     CENSORED DEATHS 0    TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      377   383   393   483   500   507   538   539   546   547                 |
 |      555   563   567   569   572   584   586   587   587   587                 |
 |      588   590   590   591   594   596   597   616   626   627                 |
 |      641   643   645   651   652   661   663   665   668   672                 |
 |      679   680   681   696   696   702   709   719                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.0  96.0  94.0  90.0  76.0  52.0  30.0      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0  98.0  94.0  92.0  92.0  88.0  72.0  50.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 |250     PPM|   100.0 100.0  98.0  98.0  96.0  94.0  86.0  72.0  60.0  26.0      |
 |           |                                                                    |
 |           |                                                                    |
 |750     PPM|   100.0 100.0 100.0 100.0  94.0  92.0  84.0  46.0  24.0   4.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      75 PPM       250     PPM  750     P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       30.0%        28.0%        26.0%         4.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.888      P=0.953      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       616.0        601.8        621.2        598.1    |
 |NATURAL DEATHS (C)      |       (14.7)       (18.9)       (16.2)       (11.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       651.4        638.8        650.5        603.5    |
 |(STANDARD ERROR)        |       (12.8)       (16.0)       (13.9)       (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)
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      18    111   194   318   486   496   507   638   651   654                 |
 |      659   665   668   683   686   687   704   721   727                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 75 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      412   462   475   506   531   601   609   609   610   636                 |
 |      646   647   668   686   719   724   724   731   731                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   449   486   502   602   624   651   658   659   662                 |
 |      674   685   689   694   699   709                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 750     PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      448   462   604   629   646   655   667   690   699   703                 |
 |      709   711   722   723                                                     |
 |  CENSORED DEATHS                                                               |
 |      527                                                                       |
 |                                                                                |
 ==================================================================================
                                   ETHYLBENZENE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.0  96.0  94.0  92.0  92.0  92.0  86.0  86.0  76.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |75 PPM     |   100.0 100.0 100.0 100.0  98.0  94.0  90.0  88.0  76.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |250     PPM|   100.0 100.0 100.0 100.0  98.0  96.0  92.0  90.0  80.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |750     PPM|   100.0 100.0 100.0 100.0 100.0  96.0  96.0  94.0  87.8  71.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      75 PPM       250     PPM  750     P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%        62.0%        68.0%        71.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.248N     P=1.000N     P=0.620N     P=0.326N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       540.7        617.2        614.8        647.7    |
 |NATURAL DEATHS (C)      |       (50.5)       (22.6)       (25.0)       (23.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       660.5        689.6        695.8        705.7    |
 |(STANDARD ERROR)        |       (23.1)       (11.7)       (11.1)       ( 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)
                                                            ETHYLBENZENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        75 PPM           = 2
                                                        250     PPM      = 3
                                                        750     PPM      = 4

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

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

      |
  100 + 1                                      2  3             1  4
      |                                        2  3     2       1  4 41   3
      |                                                 2       2    414  2       3 1 1
      |                                                                   2         4 1432  1
   90 +                                                                                432  12 1
      |                                                                                 4    2 2
      |                                                                                     34412 1 2 3
      |                                                                                       44  1 1
   80 +                                                                                        44   1 1
      |                                                                                         44  2 11
      |                                                                                          44   311
      |                                                                                                21 1
P  70 +                                                                                           4 4   2233
E     |                                                                                                  211
R     |                                                                                                   21 1
C     |                                                                                                    223   3
E  60 +                                                                                                          33
N     |                                                                                             4 4      1 1
T     |                                                                                                     22 1 1
      |                                                                                                      2 2 11 3
S  50 +                                                                                               44       2  1 13
U     |                                                                                                             113
R     |                                                                                                4 4 4      2  233
V     |                                                                                                              22
I  40 +                                                                                                    4 4       1221
V     |                                                                                                                22
A     |                                                                                                      44        322
L     |                                                                                                       44        11
   30 +                                                                                                        4 4      312 1
      |                                                                                                                  32 2
      |                                                                                                          44       3 3
      |
   20 +                                                                                                           44
      |                                                                                                            44
      |                                                                                                             4 4
      |
   10 +                                                                                                               44
      |                                                                                                                44
      |                                                                                                                 44  4
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 37 obs hidden.
                                                            ETHYLBENZENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        75 PPM           = 2
                                                        250     PPM      = 3
                                                        750     PPM      = 4

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

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

      |
  100 + 1  1                                                           3 2    4
      |
      |    1              1                                            3 2    4 32
      |
   96 +                   1            1                                        32 2 3                  4
      |
      |                                1                   1                       2 3 32               4  4
      |
   92 +                                                    1                         1 32   2          3   4  4
      |
      |                                                                              11     2          2   3  44
      |
P  88 +                                                                               1 1              22  3  34  4
E     |
R     |                                                                                 1                    133  4  4
C     |
E  84 +                                                                                                 22   113 3   44
N     |
T     |                                                                                                  2  2 11      44
      |
S  80 +                                                                                                     2 21 1 3   44
U     |
R     |                                                                                                            33
V     |
I  76 +                                                                                                       2  11 33  4 4
V     |
A     |                                                                                                           1 133
L     |
   72 +                                                                                                             2    2
      |                                                                                                                   4 4
      |                                                                                                             113 322
      |
   68 +                                                                                                              1 13   3
      |
      |                                                                                                                1 12 2
      |
   64 +                                                                                                                  11
      |
      |                                                                                                                   1 1
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.