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TDMS Study 55312-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                         COCONUT OIL ACID DIETHANOLAMINE CONDENSATE                      DATE: 02/24/99       

EXPERIMENT: 55312 TEST: 03                                                                                     TIME: 13:48:13       

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        

CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55312B       

PATHOLOGIST: TOFT, J.                                                                                          CAS: 68603-42-9      

------------------------------------------------------------------------------------------------------------------------------------

                                                                                                                                    

                                                         2 YEAR CHONIC RATS                                                         

                                                                                                                                    


               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: 02/24/99      

EXPERIMENT: 55312 TEST: 03                                                                                     TIME: 13:48:13      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: 55312B      

PATHOLOGIST: TOFT, J.                                                                                          CAS: 68603-42-9     
                    COCONUT OIL 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 41     CENSORED DEATHS 1    TERMINAL 8         |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      334   389   392   442   458   463   467   470   495   521                 |

 |      526   540   543   556   561   563   583   583   589   591                 |

 |      593   603   607   617   618   618   621   631   632   640                 |

 |      642   650   656   668   677   680   702   705   713   713                 |

 |      723                                                                       |

 |  CENSORED DEATHS                                                               |

 |      110                                                                       |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 50 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 38     CENSORED DEATHS 0    TERMINAL 12        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      380   444   474   495   499   511   523   529   534   558                 |

 |      561   574   575   579   580   586   589   600   611   611                 |

 |      617   617   620   620   621   626   656   656   670   677                 |

 |      686   695   708   710   713   720   725   728                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                          DOSE = 100     MG/KG                                  |

 |                       ----------------------------                             |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 39     CENSORED DEATHS 0    TERMINAL 11        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      329   389   421   474   485   505   508   529   552   560                 |

 |      560   562   565   579   582   586   593   607   607   620                 |

 |      621   626   627   632   640   656   666   674   677   687                 |

 |      688   690   695   698   698   701   702   711   719                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                    COCONUT OIL 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  98.0  93.9  83.7  73.5  55.1  32.7  16.3      |

 |           |                                                                    |

 |           |                                                                    |

 |50 MG/KG   |   100.0 100.0 100.0 100.0  98.0  94.0  82.0  64.0  44.0  24.0      |

 |           |                                                                    |

 |           |                                                                    |

 |100        |   100.0 100.0 100.0  98.0  94.0  90.0  84.0  66.0  48.0  22.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                    DOSE                        |

 |                                                                                |

 |                                0 MG/KG          50 MG/KG         100           |

 |                                                                  MG/KG         |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       16.3%            24.0%            22.0%         |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.324N         P=0.270N         P=0.350N      |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       579.9            602.1            600.5         |

 |NATURAL DEATHS (C)      |       (15.0)           (13.5)           (15.0)        |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       594.3            632.5            628.8         |

 |(STANDARD ERROR)        |       (17.6)           (12.9)           (13.9)        |

 |                        |                                                       |

 ==================================================================================

                                    


       (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 RATS

                       FIRST TERMINAL SACRIFICE AT 728 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0 MG/KG                                  |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      342   493   522   552   585   606   613   613   618   619                 |

 |      632   636   639   655   669   680   697   698   708   717                 |

 |      723   727                                                                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 50 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      225   271   280   382   390   408   476   514   533   533                 |

 |      562   578   578   582   585   612   637   651   677   689                 |

 |      689   692   708   712   719   722                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                          DOSE = 100     MG/KG                                  |

 |                       ----------------------------                             |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      271   294   308   314   373   374   377   387   466   479                 |

 |      522   536   537   545   557   588   620   626   639   665                 |

 |      666   669   672   689   702   715   718   724                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                    COCONUT OIL ACID DIETHANOLAMINE CONDENSATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   728 (A)   |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |           |                                                                    |

 |0 MG/KG    |   100.0 100.0 100.0  98.0  98.0  98.0  94.0  90.0  72.0  56.0      |

 |           |                                                                    |

 |           |                                                                    |

 |50 MG/KG   |   100.0 100.0  98.0  94.0  88.0  86.0  80.0  70.0  64.0  48.0      |

 |           |                                                                    |

 |           |                                                                    |

 |100        |   100.0 100.0 100.0  92.0  84.0  80.0  72.0  68.0  60.0  44.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                    DOSE                        |

 |                                                                                |

 |                                0 MG/KG          50 MG/KG         100           |

 |                                                                  MG/KG         |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       56.0%            48.0%            44.0%         |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.142          P=0.350          P=0.165       |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       624.7            554.0            536.9         |

 |NATURAL DEATHS (C)      |       (19.1)           (29.0)           (27.9)        |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       682.6            637.5            621.0         |

 |(STANDARD ERROR)        |       (11.1)           (19.4)           (20.6)        |

 |                        |                                                       |

 ==================================================================================

                                    


       (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

                                                        50 MG/KG         = 2

                                                        100     MG/KG    = 3



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



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



      |

      |

  100 + 1                                                   31       2

      |                                                     31       21       2

      |                                                               1    3  1    2  2

      |                                                                       1  1 3 322

   90 +                                                                          11  3 22

      |                                                                                 2  2

      |                                                                           11    3  222 3

      |                                                                            1  1    1 2 32

   80 +                                                                                    11   22

      |                                                                                     1 1 322

P     |                                                                                          322

E     |                                                                                       1 11 33

R  70 +                                                                                            22

C     |                                                                                          1  1 2

E     |                                                                                               2232

N     |                                                                                             1 1 3 3

T  60 +                                                                                                  22

      |                                                                                               1 1 33

S     |                                                                                                    33

U     |                                                                                                 1 1 33

R  50 +                                                                                                   22 3 3

V     |                                                                                                    2   2  3

I     |                                                                                                   1 1  2  23

V     |                                                                                                           22 3

A  40 +                                                                                                     11     22

L     |                                                                                                      11     2 2

      |                                                                                                       11     32 2

      |                                                                                                        1  1

   30 +                                                                                                           11  3322

      |                                                                                                            11  1 22

      |                                                                                                                3332 2

      |                                                                                                                113  3

   20 +

      |                                                                                                                 1 1 1

      |

      |

   10 +

      |

      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--

        0         10         20         30         40         50         60         70         80         90         100        110



                                                                   WEEK



NOTE: 29 obs hidden.
                                             COCONUT OIL 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.



      |

      |

  104 +

      |

      | 1                                   2      3          1

      |                                     2      2  3       1                       1

   96 +                                            22 3 3                             1    1

      |                                             2   3 3          2                     1   1

      |                                                   3        3 22                        1    1

      |                                                               2  2                          1   1

P  88 +                                                                  2         2                    11

E     |                                                            3  3            2     2

R     |                                                               3           3      2   2           11

C     |                                                                           3 3

E  80 +                                                                             3      3 2   2        1 1

N     |                                                                                    3 3   2 2

T     |                                                                                                     11

      |                                                                                      33    22        1 1

S  72 +                                                                                       3 3              1  1

U     |                                                                                         3   2    2        1 1

R     |                                                                                             3    23 2       1 1

V     |                                                                                                   332 2

I  64 +                                                                                                    3 32    2  1 1

V     |                                                                                                      3   3 2 2  11

A     |                                                                                                          33      11

L     |

   56 +                                                                                                              2  2 1

      |                                                                                                           3  3

      |                                                                                                              3 322

      |                                                                                                                3 22

   48 +                                                                                                                   2

      |                                                                                                                  33

      |                                                                                                                   3

      |

   40 +

      |

      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--

        0         10         20         30         40         50         60         70         80         90         100        110



                                                                   WEEK



NOTE: 5 obs hidden.