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TDMS Study 55312-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                         COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                      DATE: 09/18/97       
EXPERIMENT: 55312 TEST: 04                                                                                     TIME: 08:25:34       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55312B       
PATHOLOGIST: SINGER, A.                                                                                        CAS: 68603-42-9      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           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                         COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                      DATE: 09/18/97      
EXPERIMENT: 55312 TEST: 04                                                                                     TIME: 08:25:34      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55312B      
PATHOLOGIST: SINGER, A.                                                                                        CAS: 68603-42-9     
                    COCONUT OIL ACID DIETHANOLAMINE CONDENSATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      420   490   584   612   618   645   664   673   700                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      304   356   454   507   576   617   645   652   653   653                 |
 |      692   696   711                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      401   456   505   555   595   597   630   662   667   692                 |
 |      692   710   713   722                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                    COCONUT OIL ACID DIETHANOLAMINE CONDENSATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  94.0  86.0  82.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  90.0  80.0  74.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |200        |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  88.0  84.0  72.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          100              200           |
 |                                                 MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       82.0%            74.0%            72.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.318          P=0.456          P=0.356       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       600.7            578.2            614.1         |
 |NATURAL DEATHS (C)      |       (30.4)           (36.9)           (27.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       704.3            688.3            695.4         |
 |(STANDARD ERROR)        |       ( 8.7)           (13.2)           (10.4)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                    COCONUT OIL ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      429   479   506   568   589   617   664   679   681   687                 |
 |      701   702   713   719   726                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      473   553   561   567   584   611   616   618   629   644                 |
 |      649   678   680   691                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 200     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    366   422   506   552   564   567   580   610   610                 |
 |      621   630   632   649   653   653   661   665   672   701                 |
 |      702   711   722   728                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                    COCONUT OIL ACID DIETHANOLAMINE CONDENSATE

                       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    |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0  86.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  78.0  72.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |200        |   100.0  98.0  98.0  98.0  94.0  94.0  92.0  84.0  64.0  52.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          100              200           |
 |                                                 MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%            72.0%            52.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.056          P=1.000N         P=0.070       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       630.7            611.0            594.8         |
 |NATURAL DEATHS (C)      |       (24.7)           (15.9)           (28.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       699.5            696.0            664.6         |
 |(STANDARD ERROR)        |       ( 9.7)           ( 8.7)           (16.5)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                             COCONUT OIL 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               3 1
      |
      |                                                 2       2       3 1      3   1
      |
   96 +                                                         2               23   1  3           1
      |
P     |                                                                         2       2       3   1    1
E     |
R  92 +                                                                                 2       3  2  3  11
C     |
E     |                                                                                            2  33  1   1
N     |
T  88 +                                                                                                3  23  1  1
      |
S     |                                                                                                    3  22 1 1
U     |
R  84 +                                                                                                          331  1
V     |
I     |                                                                                                           3  31   1
V     |
A  80 +                                                                                                        2     2
L     |
      |                                                                                                              22 3
      |
   76 +                                                                                                               2 2
      |
      |                                                                                                                 2 2
      |
   72 +                                                                                                                   3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 9 obs hidden.
                                             COCONUT OIL 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              3                                                    1      2
      |
      |                3                                          3         1      21          2
      |                                                           3        3        1   1      2 2
   95 +
      |                                                                    3            1         1
      |                                                                                 3      3 21 2 1
      |
   90 +                                                                                        3 3  2 1  21
      |
      |                                                                                                   1      1
      |                                                                                          3 3     22      1 1
P  85 +
E     |                                                                                            3     322       11
R     |                                                                                                    2 2      11
C     |
E  80 +                                                                                                  33  22      1 1
N     |
T     |                                                                                                   33  2    2
      |                                                                                                    33      22  11
S  75 +
U     |                                                                                                     3 3     22  11
R     |                                                                                                       33     2   11 2
V     |
I  70 +                                                                                                                   1 1
V     |
A     |                                                                                                        3 3
L     |
   65 +
      |                                                                                                          33
      |                                                                                                           3    3
      |
   60 +
      |
      |                                                                                                                33
      |                                                                                                                 3 3
   55 +
      |
      |                                                                                                                   3 3
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.