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TDMS Study 05188-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                   SODIUM XYLENESULFONATE                                DATE: 04/04/96       
EXPERIMENT: 05188 TEST: 05                                                                                     TIME: 04:41:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55403D       
PATHOLOGIST: TOFT, J.                                                                                          CAS: 1300-72-7       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               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: 05                                                                                     TIME: 04:41:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55403D      
PATHOLOGIST: TOFT, J.                                                                                          CAS: 1300-72-7      
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   447   492   499   527   534   546   547   554   557                 |
 |      560   565   567   582   583   590   595   616   616   617                 |
 |      618   636   639   645   648   650   652   658   672   681                 |
 |      682   687   687   701   702   707   708   712   713   715                 |
 |      724   728   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      196   349   362   393   441   491   516   527   540   541                 |
 |      547   565   601   603   603   609   609   619   623   631                 |
 |      631   643   645   645   656   658   674   702   702   702                 |
 |      710   726   732                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 120     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 41     CENSORED DEATHS 0    TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      257   439   477   487   489   527   535   538   562   568                 |
 |      571   573   579   594   596   606   609   612   621   622                 |
 |      622   622   637   646   646   650   652   653   659   666                 |
 |      672   672   673   695   700   704   708   708   715   718                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 240     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 40     CENSORED DEATHS 0    TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      382   428   433   480   520   524   525   527   530   541                 |
 |      547   556   561   562   567   568   582   590   594   616                 |
 |      629   631   638   642   652   658   667   669   679   687                 |
 |      702   702   714   719   719   726   726   728   730   731                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  66.0  44.0  14.0      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0  98.0  94.0  92.0  90.0  80.0  70.0  48.0  34.0      |
 |           |                                                                    |
 |           |                                                                    |
 |120        |   100.0 100.0  98.0  98.0  98.0  94.0  84.0  70.0  42.0  18.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |240        |   100.0 100.0 100.0 100.0  98.0  92.0  80.0  62.0  48.0  20.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      60 MG/KG     120          240      |
 |                                                          MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       14.0%        34.0%        18.0%        20.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N     P=0.115N     P=0.927N     P=0.580N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       621.6        581.6        609.9        609.6    |
 |NATURAL DEATHS (C)      |       (11.9)       (21.2)       (14.3)       (14.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       637.5        633.7        632.4        634.6    |
 |(STANDARD ERROR)        |       (11.7)       (17.3)       (13.5)       (13.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 1    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      303   393   408   420   420   480   485   488   490   490                 |
 |      545   548   575   591   605   629   646   656   657   674                 |
 |      682   692   693   708   718   719   732                                   |
 |  CENSORED DEATHS                                                               |
 |      698                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      201   277   301   367   386   446   447   486   497   525                 |
 |      528   528   537   541   547   550   559   563   582   585                 |
 |      590   622   626   630   643   644   645   645   666   694                 |
 |      701   708   722   735                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 120     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   444   445   462   492   501   510   517   527   532                 |
 |      542   547   559   564   568   594   602   603   625   638                 |
 |      643   645   646   648   660   666   673   697   706   708                 |
 |      712   712   717                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 240     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      289   324   338   379   391   396   412   441   507   515                 |
 |      520   526   556   572   589   591   596   611   615   630                 |
 |      633   634   640   646   651   653   674   677   695   696                 |
 |      706   711   714   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                              SODIUM XYLENESULFONATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.0  90.0  86.0  78.0  70.0  62.0  45.7      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0  98.0  94.0  90.0  86.0  72.0  58.0  44.0  32.0      |
 |           |                                                                    |
 |           |                                                                    |
 |120        |   100.0 100.0 100.0 100.0 100.0  92.0  78.0  64.0  50.0  34.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |240        |   100.0 100.0 100.0  94.0  86.0  84.0  76.0  66.0  48.0  32.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      60 MG/KG     120          240      |
 |                                                          MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       45.7%        32.0%        34.0%        32.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.309      P=0.156      P=0.329      P=0.193  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       572.1        550.7        592.3        566.4    |
 |NATURAL DEATHS (C)      |       (23.2)       (22.2)       (15.1)       (21.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       646.7        610.0        641.2        620.6    |
 |(STANDARD ERROR)        |       (17.0)       (19.4)       (13.9)       (18.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                        60 MG/KG         = 2
                                                        120     MG/KG    = 3
                                                        240     MG/KG    = 4

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

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

      |
      |
  100 + 1                              2         3                   4       1
      |                                2         3             2     4      411
      |                                                        2 2     2    431     3311
      |                                                                2     2      4  1   41
   90 +                                                                      2       32     11
      |                                                                               2  2  311
      |                                                                                  2 4231113
      |                                                                                     4 4  33
   80 +                                                                                       22
      |                                                                                        211
P     |                                                                                         41331 322
E     |                                                                                               33
R  70 +                                                                                          44 1 133
C     |                                                                                           4 4
E     |                                                                                             4 1 212
N     |                                                                                               4  11 2
T  60 +                                                                                                  4 4
      |                                                                                                   1412
S     |                                                                                                   3 111
U     |                                                                                                      422
R  50 +
V     |                                                                                                       11  42
I     |                                                                                                        1 312   2
V     |                                                                                                          31414
A  40 +                                                                                                              4 22
L     |                                                                                                             11  2 2
      |                                                                                                           33 131442 2
      |
   30 +                                                                                                               33 44
      |                                                                                                                11
      |                                                                                                                 334 4
      |                                                                                                                 11
   20 +                                                                                                                  11 4
      |                                                                                                                   3 3
      |                                                                                                                   1 1
      |
   10 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 58 obs hidden.
                                                       SODIUM XYLENESULFONATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        60 MG/KG         = 2
                                                        120     MG/KG    = 3
                                                        240     MG/KG    = 4

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

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

      |
      |
  104 +
      |
      | 1                               2             4 1                    3
      |                                 2           2 4 1   4          1     33
   96 +                                             2  2    4 4        1 1
      |                                                2      4   2  4   11   3  3
      |                                                           2  42          3    3
      |                                                               24  1   2     1 33
   88 +                                                                4 4          11 33
      |                                                                  4   42      2  33
P     |                                                                      4       22 43  3
E     |                                                                               2 44 2
R  80 +                                                                              1   4 22 1
C     |                                                                                    44 11
E     |                                                                                     22 13  1
N     |                                                                                      22 3341  1
T  72 +                                                                                       22 33   1 1
      |                                                                                           3   3 1  1
S     |                                                                                        22     33   1  1
U     |                                                                                         22     334    11
R  64 +                                                                                          2  2   3  3
V     |                                                                                                  4 3 3 1   1
I     |                                                                                             2 2    44      11
V     |                                                                                               2   2  33     11
A  56 +                                                                                                   2244
L     |                                                                                                      44      1  1
      |                                                                                                    2 23  3      11
      |                                                                                                       44 33
   48 +                                                                                                      224  33     1  1
      |                                                                                                            3  3     11
      |                                                                                                       2   24  33
      |                                                                                                           2   233
   40 +                                                                                                               22
      |                                                                                                                22
      |                                                                                                                 232
      |                                                                                                                 432 23
   32 +                                                                                                                   4 22
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 29 obs hidden.