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TDMS Study 05109-12 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                      TRIETHANOLAMINE                                    DATE: 05/20/95       
EXPERIMENT: 05109 TEST: 12                                                                                     TIME: 00:27:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D       
PATHOLOGIST: R. PERSING                      S. GRUMBEIN                                                       CAS: 102-71-6        
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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                                      TRIETHANOLAMINE                                    DATE: 05/20/95      
EXPERIMENT: 05109 TEST: 12                                                                                     TIME: 00:27:28      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85226                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61621D      
PATHOLOGIST: R. PERSING                      S. GRUMBEIN                                                       CAS: 102-71-6       

                                  TRIETHANOLAMINE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      367   616   678   712                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      515   537   621   665   666   667   682   683   688   716                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 630     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      373   493   507   540   607   645   652   670   677   694                 |
 |      697                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                  TRIETHANOLAMINE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 2000    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      572   579   606   655   670   675   678   712   724                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                  TRIETHANOLAMINE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  98.3  96.3  92.3      |
 |           |                                                                    |
 |           |                                                                    |
 |200        |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  92.0  80.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |630        |   100.0 100.0 100.0 100.0  98.3  98.3  92.3  92.3  86.3  78.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |2000       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  82.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      200          630          2000     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       92.3%        80.0%        78.3%        82.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.623      P=0.151      P=0.087      P=0.231  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       593.3        644.0        595.9        652.3    |
 |NATURAL DEATHS (C)      |       (78.0)       (21.1)       (31.5)       (18.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       674.5        669.3        659.1        672.0    |
 |(STANDARD ERROR)        |       (14.2)       (13.5)       (14.6)       (13.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  TRIETHANOLAMINE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     197   289   350   487   512   534   572   681   698                 |
 |      700                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     414   557   578   639   650   675   675   685   713                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 300     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 10   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      320   434   540   579   597   603   624   669   674   682                 |
 |      712   716                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  TRIETHANOLAMINE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 1000    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      317   415   521   537   551   591   647   661   670   680                 |
 |      699   712   712                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  TRIETHANOLAMINE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |    98.3  98.3  96.7  93.3  93.3  93.3  87.2  85.2  85.2  79.1      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |    98.3  98.3  98.3  98.3  96.7  96.7  96.7  92.6  88.6  80.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |300        |   100.0 100.0 100.0  98.3  98.3  96.7  94.7  88.6  86.6  76.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0 100.0  98.3  96.7  96.7  92.6  88.6  84.6  74.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      100          300          1000     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       79.1%        80.6%        76.5%        74.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.660      P=0.916N     P=1.000      P=0.892  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       457.2        559.5        595.8        593.3    |
 |NATURAL DEATHS (C)      |       (67.3)       (67.1)       (34.1)       (33.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       633.8        655.4        657.0        654.3    |
 |(STANDARD ERROR)        |       (20.6)       (17.7)       (15.0)       (15.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                          TRIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        200     MG/KG    = 2
                                                        630     MG/KG    = 3
                                                        2000    MG/KG    = 4

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

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

        |
        |
  100.0 +1                                                         13                     2        4
        |
        |
        |                                                          13                  3  2   2    44     1
   97.5 +
        |
        |                                                                              3 3    2     4    412        1
        |
   95.0 +
        |                                                                                3     3                    1    1
P       |                                                                                                4 2    4 2
E       |
R  92.5 +                                                                                      3         3               1   1
C       |                                                                                                       4 22
E       |
N       |
T  90.0 +                                                                                                3     3   44
        |
S       |
U       |                                                                                                      33  2 2
R  87.5 +
V       |
I       |                                                                                                       3  34    4
V       |
A  85.0 +
L       |                                                                                                          33
        |                                                                                                            22  4 4
        |
   82.5 +                                                                                                           3  3
        |                                                                                                             2   24 4
        |
        |
   80.0 +                                                                                                                 2  2
        |
        |
        |                                                                                                              3     3
   77.5 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 4 obs hidden.

                                                          TRIETHANOLAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        100     MG/KG    = 2
                                                        300     MG/KG    = 3
                                                        1000    MG/KG    = 4

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

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

      |
      |
  100 + 1 1                                                3
      |   1                             1                  3              2 3
      |
      |                                 1             1                   2 3              4  3 2
P  95 +                                               1        1                           4 43 2  2
E     |                                                        1                     1
R     |                                                                                      4 4   2   3     2
C     |                                                                              1   1     4      433    22
E  90 +
N     |                                                                                  1   1        4 3  3  2    2
T     |                                                                                      1    1
      |                                                                                                    3  4  43
S  85 +                                                                                           1              4321
U     |                                                                                                             1 1
R     |                                                                                                           432   2
V     |
I  80 +                                                                                                             3 4 2   2
V     |                                                                                                               1 33  1
A     |
L     |                                                                                                                  3  3
   75 +                                                                                                                 4   4
      |
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 21 obs hidden.