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TDMS Study 55323-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                            LAURIC ACID DIETHANOLAMINE CONDENSATE                        DATE: 07/30/97       
EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 07:35:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B       
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           2 YEAR CHRONIC                                                           
                                                                                                                                    

               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: 07/30/97      
EXPERIMENT: 55323 TEST: 04                                                                                     TIME: 07:35:44      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55323B      
PATHOLOGIST: M. RYAN                                                                                           CAS: 120-40-1       
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      344   353   541   562   584   616   622   636   646   670                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      164   415   462   528   595   626   637   638   668   706                 |
 |      706   717   719                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   492   519   554   560   573   611   643   730                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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  96.0  96.0  96.0  94.0  90.0  82.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0  98.0  98.0  98.0  96.0  94.0  92.0  90.0  84.0  74.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |200        |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  88.0  84.0  82.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          100              200           |
 |                                                 MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.0%            74.0%            82.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.901N         P=0.684          P=1.000N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       557.4            583.2            569.6         |
 |NATURAL DEATHS (C)      |       (36.9)           (44.1)           (28.3)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       699.5            695.5            705.2         |
 |(STANDARD ERROR)        |       (12.4)           (14.6)           (10.3)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      410   542   562   562   602   624   629   638   643   646                 |
 |      671   719   720                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 1    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      481   574   638   638   651   656   666   668   731                       |
 |  CENSORED DEATHS                                                               |
 |      205                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 1    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   457   476   517   523   539   583   596   615   616                 |
 |      617   625   625   646   650   653   680   720   720   728                 |
 |  CENSORED DEATHS                                                               |
 |      84                                                                        |
 |                                                                                |
 ==================================================================================
                       LAURIC ACID DIETHANOLAMINE CONDENSATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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    |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  90.0  80.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  95.9  87.8  81.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |200        |   100.0 100.0 100.0 100.0  98.0  93.9  87.8  83.7  67.3  59.2      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          100              200           |
 |                                                 MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.0%            81.6%            59.2%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.109          P=0.445N         P=0.158       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       612.9            633.7            600.0         |
 |NATURAL DEATHS (C)      |       (22.7)           (23.4)           (19.8)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       704.0            707.0            668.6         |
 |(STANDARD ERROR)        |       ( 9.6)           (12.3)           (17.1)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                        100     MG/KG    = 2
                                                        200     MG/KG    = 3

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

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

      |
      |
  100 + 1                         2                            1              3
      |
      |                           2                            11         2   3       3
      |                                                         1         2      2    3    3  1
P  95 +
E     |                                                                          2         32 1 31
R     |                                                                                     2    1  1 2
C     |
E  90 +                                                                                         3 3 1 2  1 2
N     |
T     |                                                                                           3      1122
      |                                                                                                  31 12
S  85 +
U     |                                                                                                     121   2         3
R     |                                                                                                       1   1    2    3
V     |
I  80 +                                                                                                           1         1
V     |
A     |                                                                                                                2 2
L     |
   75 +
      |                                                                                                                  2  2
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.
                                               LAURIC ACID DIETHANOLAMINE CONDENSATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        100     MG/KG    = 2
                                                        200     MG/KG    = 3

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

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

      |
      |
  100 + 1                                                                13         2
      |
      |                                                                  13      3  2         1   2
      |                                                                          3 3          1  12          2
   95 +
      |                                                                            3     3
      |                                                                                          1     1
      |                                                                                  3 3                 22
   90 +                                                                                    3 3         1   1  22
      |
P     |                                                                                      3      3          2  2
E     |                                                                                             3  3   1 1
R  85 +
C     |                                                                                                3 3        2         2
E     |                                                                                                      11
N     |                                                                                                                     22
T  80 +                                                                                                  33   1   1
      |
S     |                                                                                                   33      1      1
U     |
R  75 +
V     |                                                                                                    3  3          1   1
I     |
V     |
A  70 +                                                                                                       33
L     |
      |                                                                                                        3    3
      |
   65 +                                                                                                             3    3
      |
      |
      |                                                                                                                  33
   60 +
      |                                                                                                                   3  3
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 2 obs hidden.