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TDMS Study 05162-09 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 04/08/96       
EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 10:59:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D       
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 04/08/96      
EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 10:59:36      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D      
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2       
                                  DIETHANOLAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      101   302   394   479   507   560   561   561   582   595                 |
 |      610   619   645   653   663   666   670   670   670   673                 |
 |      674   680   683   687   687   687   689   694   696   702                 |
 |      702   702   709   710   717   723                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 16 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 40     CENSORED DEATHS 0    TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      463   509   538   541   542   554   560   562   572   576                 |
 |      577   577   584   599   606   610   619   625   638   639                 |
 |      640   642   648   661   662   663   666   670   670   673                 |
 |      678   681   688   694   695   702   704   722   723   723                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 32 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      471   499   504   527   533   542   556   568   599   618                 |
 |      635   659   663   664   681   681   689   694   702   702                 |
 |      702   702   709   710   710   715   715   722   723                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 64 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      277   379   431   465   530   533   533   541   542   561                 |
 |      577   587   621   632   640   641   642   643   653   656                 |
 |      688   688   689   701   709   709   722   728                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0  98.0  98.0  96.0  94.0  92.0  90.0  80.0  70.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 |16 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  72.0  48.0  20.0      |
 |           |                                                                    |
 |           |                                                                    |
 |32 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  88.0  82.0  72.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 |64 MG/KG   |   100.0 100.0 100.0  98.0  96.0  92.0  82.0  76.0  60.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       28.0%        20.0%        42.0%        44.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.066N     P=0.204      P=0.125N     P=0.279N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.1        627.4        641.2        597.1    |
 |NATURAL DEATHS (C)      |       (21.4)       (10.2)       (14.9)       (20.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       650.6        647.7        678.1        655.1    |
 |(STANDARD ERROR)        |       (16.9)       (10.0)       (10.6)       (14.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                  DIETHANOLAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   460   489   506   522   531   579   589   597   600                 |
 |      606   622   632   638   648   650   652   653   658   666                 |
 |      671   678   697   701   729                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 8 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      323   492   541   544   556   589   597   638   641   655                 |
 |      666   681   689   699   702   703   703   703   704   722                 |
 |      724                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 16 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      351   365   434   490   561   579   591   606   619   634                 |
 |      648   656   665   677   679   692   694   695   697   719                 |
 |      727                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 32 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      395   430   465   486   490   515   559   565   572   584                 |
 |      589   609   621   629   642   646   656   668   669   675                 |
 |      699   700   703   706   717   728                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                  DIETHANOLAMINE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  80.0  62.0  50.0      |
 |           |                                                                    |
 |           |                                                                    |
 |8 MG/KG    |   100.0 100.0 100.0  98.0  98.0  98.0  92.0  86.0  80.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |16 MG/KG   |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  86.0  74.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |32 MG/KG   |   100.0 100.0 100.0 100.0  98.0  94.0  88.0  78.0  66.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       50.0%        58.0%        58.0%        48.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.709      P=0.337N     P=0.448N     P=0.982  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       608.5        632.0        608.5        604.5    |
 |NATURAL DEATHS (C)      |       (15.5)       (21.5)       (24.2)       (18.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       669.2        688.8        679.0        664.8    |
 |(STANDARD ERROR)        |       (11.6)       (11.3)       (13.2)       (13.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                           DIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        16 MG/KG         = 2
                                                        32 MG/KG         = 3
                                                        64 MG/KG         = 4

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

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

      |
      |
  100 + 1                1                          4                             23
      |                  1                          4   1            4            23   32
      |                                                 1            4 1    4     4 1  32   322
      |                                                                           4 1   1   33
   90 +                                                                                 1   432 1
      |                                                                                       3 11
      |                                                                                      44 212 1  3
      |                                                                                       4  4221 13  3
P  80 +                                                                                          4 4  1  13 3
E     |                                                                                            44    11 3    3
R     |                                                                                            22  2  1 4 11
C     |                                                                                                22   44 1 1  3
E  70 +                                                                                                 22       11
N     |                                                                                                  22         33
T     |                                                                                                   22 2 4     333
      |                                                                                                           11
S  60 +                                                                                                        4     4
U     |                                                                                                            11
R     |                                                                                                      22  2  11 33
V     |                                                                                                                44
I  50 +                                                                                                                 33
V     |                                                                                                          22     4 4
A     |                                                                                                              11  33 4
L     |                                                                                                           22  11  3 3
   40 +
      |                                                                                                            22
      |                                                                                                             22211
      |                                                                                                                 11
   30 +                                                                                                               22 11
      |                                                                                                                   1 1
      |                                                                                                                2  2
      |
   20 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 30 obs hidden.
                                                           DIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        8 MG/KG          = 2
                                                        16 MG/KG         = 3
                                                        32 MG/KG         = 4

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

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

      |
      |
  104 +
      |
      | 1                                                   2   3      4     1
      |                                                     2   3 3    4    41   1    2
   96 +                                                           3         3    14  12       2
      |                                                                     3     4  1  1
P     |                                                                              3  1  1  2 23
E     |                                                                              4   4 11   23 3  2
R  88 +                                                                                  4  1   4  1  22
C     |                                                                                         44 1  123    2
E     |                                                                                          44   113 3
N     |                                                                                           4 4     3 32 2
T  80 +                                                                                             4 411   3 32  2
      |                                                                                               4 1 1   33  2 2
S     |                                                                                                 4 1 1  3 3  22
U     |                                                                                                   4411   3 3 22
R  72 +                                                                                                    4 11       22
V     |                                                                                                      44    3 3
I     |                                                                                                       11     33
V     |                                                                                                        4  4
A  64 +
L     |                                                                                                        1  14  32 32
      |                                                                                                            4  4  33
      |                                                                                                           11      2 2
   56 +                                                                                                            1  14
      |                                                                                                               11
      |                                                                                                                1 4  1
      |                                                                                                                  44 1
   48 +                                                                                                                   4 4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.