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TDMS Study 55323-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 07/17/97       
EXPERIMENT: 55323 TEST: 03                                                                                     TIME: 12:31:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B       
PATHOLOGIST: J. YARRINGTON                                                                                     CAS: 120-40-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             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                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 07/17/97      
EXPERIMENT: 55323 TEST: 03                                                                                     TIME: 12:31:16      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B      
PATHOLOGIST: J. YARRINGTON                                                                                     CAS: 120-40-1       
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

                       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 38     CENSORED DEATHS 0    TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      500   506   509   535   563   565   565   565   569   583                 |
 |      589   589   607   609   618   624   626   634   641   645                 |
 |      646   654   668   670   674   680   684   689   691   702                 |
 |      703   708   710   710   715   715   716   726                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 32     CENSORED DEATHS 0    TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      430   485   500   526   526   527   537   544   557   578                 |
 |      582   589   597   613   614   618   620   625   626   626                 |
 |      634   646   653   658   662   663   674   680   684   696                 |
 |      705   719                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 1    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      266   513   522   527   555   557   558   583   583   589                 |
 |      589   589   603   603   606   632   642   645   654   670                 |
 |      683   684   689   695   696   703   703   703   717   719                 |
 |      719   726   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      106                                                                       |
 |                                                                                |
 ==================================================================================
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

                       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    |   100.0 100.0 100.0 100.0 100.0 100.0  92.0  76.0  56.0  24.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0  96.0  84.0  74.0  48.0  36.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0  98.0  98.0  98.0  98.0  91.8  71.4  61.2  32.7      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          50 MG/KG         100           |
 |                                                                  MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       24.0%            36.0%            32.7%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.413N         P=0.614N         P=0.405N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       634.3            606.1            625.8         |
 |NATURAL DEATHS (C)      |       (10.7)           (12.3)           (16.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       657.0            650.3            648.4         |
 |(STANDARD ERROR)        |       (10.0)           (11.5)           (16.8)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 1    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      322   374   416   471   475   479   499   521   527   564                 |
 |      617   640   654   662   667   669   682   688   691   694                 |
 |      707                                                                       |
 |  CENSORED DEATHS                                                               |
 |      219                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      238   403   458   489   518   522   527   534   575   582                 |
 |      582   588   591   594   605   623   627   634   645   680                 |
 |      696   710   717   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 1    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      323   347   361   363   364   398   427   465   507   525                 |
 |      535   588   594   595   602   634   639   646   655   680                 |
 |      684   693   701   703   722   724   724                                   |
 |  CENSORED DEATHS                                                               |
 |      36                                                                        |
 |                                                                                |
 ==================================================================================
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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    |   100.0 100.0 100.0  98.0  93.9  87.8  81.6  79.6  71.4  57.1      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0  98.0  98.0  96.0  94.0  84.0  70.0  62.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0  89.8  87.8  83.7  77.6  69.4  61.2  44.9      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          50 MG/KG         100           |
 |                                                                  MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.1%            52.0%            44.9%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.274          P=0.734          P=0.301       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       572.3            577.8            562.9         |
 |NATURAL DEATHS (C)      |       (25.7)           (22.4)           (26.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       653.0            656.4            625.5         |
 |(STANDARD ERROR)        |       (17.7)           (15.1)           (21.8)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                               LAURIC ACID DIETHANOLAMINE CONDENSATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        50 MG/KG         = 2
                                                        100     MG/KG    = 3

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

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

      |
      |
  100 + 1                                         3                         2          1
      |                                           3                         2        2 113
      |                                                                              2 213 321
      |                                                                                     31  31
   90 +
      |                                                                                     22
      |                                                                                      22 211 3
      |                                                                                         2 121 3
P  80 +                                                                                            21 1
E     |                                                                                             2 2
R     |                                                                                               1212
C     |                                                                                                 1 1
E  70 +                                                                                                 32113
N     |                                                                                                     33
T     |                                                                                                   21113
      |                                                                                                      113
S  60 +                                                                                                    22  3  3 3
U     |                                                                                                     2 11
R     |                                                                                                       21  1 33
V     |                                                                                                        2 211 33
I  50 +                                                                                                            11 33
V     |                                                                                                          2 2
A     |                                                                                                            211
L     |                                                                                                             2121 3
   40 +                                                                                                               22
      |                                                                                                                1123
      |                                                                                                                  2  2
      |                                                                                                                 113 3
   30 +
      |
      |                                                                                                                  11 1
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 26 obs hidden.
                                               LAURIC ACID DIETHANOLAMINE CONDENSATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        50 MG/KG         = 2
                                                        100     MG/KG    = 3

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

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

      |
      |
  100 + 1                                    2             13
      |                                      2             13  3   1    2
      |                                                        3 3 1    2 1      2 1 2
      |                                                                              2   2
P  90 +                                                          3     3           11    2 2
E     |                                                                3   3        1  1   22
R     |                                                                    3      3    1   122     2
C     |                                                                           3     3  11    1 22
E  80 +                                                                                    3 3   1        1
N     |                                                                                      3      3     1  1
T     |                                                                                             2 2      1 1
      |                                                                                               232      1 11
S  70 +                                                                                                32 2 3
U     |                                                                                                   2233    1 1
R     |                                                                                                    2232     11
V     |                                                                                                       23    2
I  60 +                                                                                                        3    2111
V     |                                                                                                             33212   1
A     |                                                                                                              3 3222
L     |                                                                                                                   2 2
   50 +                                                                                                                3  3
      |
      |                                                                                                                   3 3
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.