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TDMS Study 88120-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                P,P'-DICHLORODIPHENYL SULFONE                            DATE: 09/24/99       

EXPERIMENT: 88120 TEST: 04                                                                                     TIME: 08:35:44       

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

CONT: NO1-ES-55388                              ROUTE: DOSED FEED                                              NTP C#: 88120B       

PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 80-07-9         

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

                                                                                                                                    

                                                             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                                P,P'-DICHLORODIPHENYL SULFONE                            DATE: 09/24/99      

EXPERIMENT: 88120 TEST: 04                                                                                     TIME: 08:35:44      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-55388                              ROUTE: DOSED FEED                                              NTP C#: 88120B      

PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 80-07-9        
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      30    550   603   631   649   661   666   691   693   732                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 30 PPM                                   |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      61    565   652   712   718                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 100 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      15    406   413   513   649   705                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 300 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      16    369   379   407   485   609   702   712                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   733 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |0 PPM      |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  94.0  88.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 |30 PPM     |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  96.0  94.0  90.0      |

 |           |                                                                    |

 |           |                                                                    |

 |100 PPM    |    98.0  98.0  98.0  98.0  94.0  94.0  92.0  92.0  90.0  88.0      |

 |           |                                                                    |

 |           |                                                                    |

 |300 PPM    |    98.0  98.0  98.0  98.0  92.0  90.0  90.0  90.0  88.0  84.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 PPM        30 PPM       100 PPM      300 PPM  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       80.0%        90.0%        88.0%        84.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=1.000      P=0.254N     P=0.446N     P=0.837N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       590.6        541.6        450.2        459.9    |

 |NATURAL DEATHS (C)      |       (64.3)       ( 123)       ( 100)       (80.1)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       704.5        713.9        699.1        689.3    |

 |(STANDARD ERROR)        |       (14.8)       (13.8)       (17.2)       (18.7)   |

 |                        |                                                       |

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

                                    


       (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)
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 734 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      491   580   600   631   636   657   705   711                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 30 PPM                                   |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      512   512   550   592   605   616   667   690   694   731                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 100 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      586   652   683   702   709   711   732                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 734 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 300 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      578   690   701   723   726                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                           P,P'-DICHLORODIPHENYL SULFONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 734 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   734 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |0 PPM      |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  88.0  84.0      |

 |           |                                                                    |

 |           |                                                                    |

 |30 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  88.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 |100 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  86.0      |

 |           |                                                                    |

 |           |                                                                    |

 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 PPM        30 PPM       100 PPM      300 PPM  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       84.0%        80.0%        86.0%        90.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.258N     P=0.769      P=0.924N     P=0.507N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       626.4        616.9        682.1        683.6    |

 |NATURAL DEATHS (C)      |       (25.2)       (24.5)       (18.6)       (27.2)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       716.8        710.6        726.7        729.0    |

 |(STANDARD ERROR)        |       ( 6.8)       ( 8.2)       ( 3.5)       ( 3.3)   |

 |                        |                                                       |

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

                                    


       (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)
                                                   P,P'-DICHLORODIPHENYL SULFONE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        30 PPM           = 2

                                                        100 PPM          = 3

                                                        300 PPM          = 4



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



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



      |

  100 + 1  3  1   2

      |

      |

      |

   98 +    3  1   2                                               4     3                      1 2

      |

      |

      |

   96 +                                                           4  4  33                     1 2      1      2

      |

      |

      |

P  94 +                                                              4   3               3              1   1  2        2

E     |

R     |

C     |

E  92 +                                                                  4           4   3                  1 1         22

N     |

T     |

      |

S  90 +                                                                              4                  4     1  1     3 2  2

U     |

R     |

V     |

I  88 +                                                                                                 4        11    3    3

V     |

A     |

L     |

   86 +                                                                                                           1  1 44

      |

      |

      |

   84 +                                                                                                                 4   4

      |

      |

      |

   82 +                                                                                                              1      1

      |

      |

      |

   80 +                                                                                                                     1

      |

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

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



                                                                   WEEK



NOTE: 9 obs hidden.
                                                   P,P'-DICHLORODIPHENYL SULFONE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        30 PPM           = 2

                                                        100 PPM          = 3

                                                        300 PPM          = 4



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



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



      |

  100 + 1                                                                             1  2         43

      |

      |

      |

   98 +                                                                               1            13          3     4

      |

      |

      |

   96 +                                                                                  2     2   1   1       3    34 4

      |

      |

      |

P  94 +                                                                                        2      21    1       3  3  4

E     |

R     |

C     |

E  92 +                                                                                               2 2              33

N     |

T     |

      |

S  90 +                                                                                                 22  1  1          4 4

U     |

R     |

V     |

I  88 +                                                                                                  2     1  2    13   3

V     |

A     |

L     |

   86 +                                                                                                           2  2 11   3

      |

      |

      |

   84 +                                                                                                              22 1   1

      |

      |

      |

   82 +                                                                                                               2     2

      |

      |

      |

   80 +                                                                                                                     2

      |

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

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



                                                                   WEEK



NOTE: 5 obs hidden.

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