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TDMS Study 05188-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                   SODIUM XYLENESULFONATE                                DATE: 04/04/96       
EXPERIMENT: 05188 TEST: 06                                                                                     TIME: 05:13:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55403D       
PATHOLOGIST: SINGER, A.                                                                                        CAS: 1300-72-7       
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                   SODIUM XYLENESULFONATE                                DATE: 04/04/96      
EXPERIMENT: 05188 TEST: 06                                                                                     TIME: 05:13:03      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55403D      
PATHOLOGIST: SINGER, A.                                                                                        CAS: 1300-72-7      
                              SODIUM XYLENESULFONATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      494   564   575   575   646   647   651   674   680   686                 |
 |      687   690   691   691   697   702   705   706                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 182     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      322   540   588   610   620   639   658   659   674   680                 |
 |      687   702   706                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 364     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      506   548   561   572   612   636   644   686   687   718                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 727     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      457   543   569   585   621   631   634   658   664   691                 |
 |      707   707   712   712   721                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  86.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |182        |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  94.0  84.0  74.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |364        |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  86.0  78.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |727        |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  82.0  70.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      182          364          727      |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.0%        74.0%        78.0%        70.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.681N     P=0.440N     P=0.218N     P=0.635N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       653.4        621.9        626.5        640.8    |
 |NATURAL DEATHS (C)      |       (14.3)       (28.3)       (22.0)       (19.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       704.3        704.1        709.6        705.3    |
 |(STANDARD ERROR)        |       ( 7.5)       (10.0)       ( 7.8)       ( 8.3)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 740 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      292   453   461   495   499   589   620   621   621   659                 |
 |      659   670   679   680   692   701   722   726   734                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 182     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      24    337   411   446   467   538   604   625   636   642                 |
 |      659   666   674   712   718   731   735                                   |
 |  CENSORED DEATHS                                                               |
 |      618                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 364     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      561   562   575   588   601   602   622   636   642   654                 |
 |      659   661   672   674   679   685   728   732                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 740 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 727     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      72    403   534   612   627   629   675   686   691   694                 |
 |      707   717   730   738                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 740 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   740 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.0  98.0  94.0  90.0  88.0  78.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |182        |    98.0  98.0  98.0  96.0  94.0  90.0  88.0  86.0  77.8  65.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |364        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  88.0  76.0  64.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |727        |    98.0  98.0  98.0  98.0  96.0  96.0  94.0  94.0  88.0  72.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      182          364          727      |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%        65.5%        64.0%        72.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.305N     P=0.896N     P=0.967N     P=0.335N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       609.1        566.2        640.7        608.2    |
 |NATURAL DEATHS (C)      |       (27.0)       (44.6)       (12.2)       (47.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       690.3        678.5        704.3        703.1    |
 |(STANDARD ERROR)        |       (13.6)       (19.0)       ( 8.1)       (15.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                       SODIUM XYLENESULFONATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        182     MG/KG    = 2
                                                        364     MG/KG    = 3
                                                        727     MG/KG    = 4

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

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

      |
      |
  100 + 1                                                  2                     4    1 3
      |
      |                                                    2                     4    1 3     23 1
      |                                                                                       23 1412
   95 +
      |                                                                                          33 2    2
      |                                                                                           314    22   1
      |
P  90 +                                                                                                  32 32
E     |
R     |                                                                                                     32 2
C     |                                                                                                     4312 2 13
E  85 +
N     |                                                                                                        4 2 113
T     |                                                                                                          4 223   3
      |
S  80 +                                                                                                             11 4 33
U     |
R     |                                                                                                              2 2  3 3
V     |                                                                                                                44
I  75 +
V     |                                                                                                                2    2
A     |                                                                                                              11 44
L     |
   70 +                                                                                                               11 4  4
      |
      |
      |
   65 +
      |                                                                                                                1    1
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 21 obs hidden.
                                                       SODIUM XYLENESULFONATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        182     MG/KG    = 2
                                                        364     MG/KG    = 3
                                                        727     MG/KG    = 4

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

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

      |
      |
  100 + 1   2       4                                 1                                          3
      |
      |     2       4                                 1       2         4       1
      |                                                       2         42      11           4   3 3
   95 +
      |                                                                  2    2  1    1      4     33    4
      |                                                                       2   2   11            3  3 4 4
      |
P  90 +                                                                           2    1     2        1
E     |
R     |                                                                                      2        132 14       4
C     |                                                                                                 2 323      44
E  85 +
N     |                                                                                                    223      44
T     |                                                                                                   1 22 3 1   44
      |
S  80 +                                                                                                      2 3 2    44
U     |
R     |                                                                                                          11    4 4
V     |                                                                                                          311     4  4
I  75 +
V     |                                                                                                           311   2   44
A     |                                                                                                             11       4
L     |                                                                                                                 22
   70 +                                                                                                            331 1 2  2
      |
      |                                                                                                             3  1  1
      |                                                                                                                   3 3
   65 +                                                                                                                     22
      |                                                                                                                   1 13
      |                                                                                                                     11
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 16 obs hidden.