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TDMS Study 88036-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                       ANTHRAQUINONE                                     DATE: 02/25/99       

EXPERIMENT: 88036 TEST: 03                                                                                     TIME: 11:51:59       

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

CONT: N01-ES-25337                              ROUTE: DOSED FEED                                              NTP C#: C88036       

PATHOLOGIST: SINGER, A.                                                                                        CAS: 84-65-1         

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

                                                                                                                                    

                                                        2 YEAR CHRONIC RATS                                                         

                                                                                                                                    


               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     

                                       25020 Natural Death                                                                          

                                       25021 Terminal Sacrifice                                                                     

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    

LAB: Battelle Columbus                                       ANTHRAQUINONE                                     DATE: 02/25/99      

EXPERIMENT: 88036 TEST: 03                                                                                     TIME: 11:51:59      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: N01-ES-25337                              ROUTE: DOSED FEED                                              NTP C#: C88036      

PATHOLOGIST: SINGER, A.                                                                                        CAS: 84-65-1        
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      485   499   537   540   555   562   565   565   593   617                 |

 |      620   631   642   645   648   648   665   669   674   677                 |

 |      681   687   688   690   705   708   724   724                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 469 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      477   481   597   597   615   641   642   645   663   663                 |

 |      663   668   669   674   676   676   676   682   705   705                 |

 |      708   710   718   724   724   724   724                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 938 PPM                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      312   477   561   565   596   603   603   620   638   643                 |

 |      648   648   663   666   680   682   687   699   704   705                 |

 |      705   705   719   719   723   723   724   724                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 1875 PPM                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      249   537   583   593   605   620   628   628   637   653                 |

 |      663   674   681   690   690   690   690   705   705   717                 |

 |      719   719   719   727                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 3750 PPM                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      61    421   466   484   537   593   603   607   607   624                 |

 |      638   641   641   646   667   671   677   680   682   684                 |

 |      690   690   690   690   697   699   705   724                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       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 PPM      |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  66.0  44.0      |

 |           |                                                                    |

 |           |                                                                    |

 |469 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  96.0  92.0  78.0  46.0      |

 |           |                                                                    |

 |           |                                                                    |

 |938 PPM    |   100.0 100.0 100.0  98.0  98.0  96.0  96.0  86.0  74.0  44.0      |

 |           |                                                                    |

 |           |                                                                    |

 |1875 PPM   |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  90.0  78.0  52.0      |

 |           |                                                                    |

 |           |                                                                    |

 |3750 PPM   |    98.0  98.0  98.0  98.0  96.0  92.0  90.0  86.0  72.0  44.0      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS


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

 |                                               SURVIVAL SUMMARY STATISTICS                                                   |

 |                                                                                                                             |

 |                                                                                                                             |

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

 |                                                                           DOSE                                              |

 |                                                                                                                             |

 |                                0 PPM              469 PPM            938 PPM            1875 PPM           3750 PPM         |

 |                                                                                                                             |

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

 |SURVIVAL AT END OF STUDY|       44.0%              46.0%              44.0%              52.0%              44.0%            |

 |(KAPLAN-MEIER)          |                                                                                                    |

 |                        |                                                                                                    |

 |SIGNIFICANCE (B)        |       P=1.000            P=0.639N           P=0.823N           P=0.324N           P=1.000N         |

 |(LIFE TABLE)            |                                                                                                    |

 |                        |                                                                                                    |

 |MEAN DAY OF             |       630.1              661.0              647.9              646.8              614.8            |

 |NATURAL DEATHS (C)      |       (12.9)             (12.3)             (16.9)             (20.1)             (25.0)           |

 |(STANDARD ERROR)        |                                                                                                    |

 |                        |                                                                                                    |

 |MEAN LIFE SPAN (D)      |       673.6              692.3              683.6              689.5              665.1            |

 |(STANDARD ERROR)        |       (10.0)             ( 8.2)             (11.0)             (11.2)             (16.1)           |

 |                        |                                                                                                    |

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

                                    


       (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)
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      550   571   571   575   605   617   617   635   645   645                 |

 |      649   652   662   665   666   676   676   681   689   702                 |

 |      703   704   713   715   718   718   718                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 469 PPM                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      513   575   589   592   606   645   647   679   694   718                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 938 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      85    506   570   571   571   625   638   652   655   676                 |

 |      703   703   718   723   723                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 1875 PPM                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      550   611   634   635   638   647   675   689   701   704                 |

 |      722   723   723                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 3750 PPM                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      486   536   689   699   709   712   718   718   722   724                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   730 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |0 PPM      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  90.0  72.0  46.0      |

 |           |                                                                    |

 |           |                                                                    |

 |469 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  86.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 |938 PPM    |    98.0  98.0  98.0  98.0  98.0  98.0  96.0  90.0  82.0  70.0      |

 |           |                                                                    |

 |           |                                                                    |

 |1875 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  88.0  74.0      |

 |           |                                                                    |

 |           |                                                                    |

 |3750 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  96.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS


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

 |                                               SURVIVAL SUMMARY STATISTICS                                                   |

 |                                                                                                                             |

 |                                                                                                                             |

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

 |                                                                           DOSE                                              |

 |                                                                                                                             |

 |                                0 PPM              469 PPM            938 PPM            1875 PPM           3750 PPM         |

 |                                                                                                                             |

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

 |SURVIVAL AT END OF STUDY|       46.0%              80.0%              70.0%              74.0%              80.0%            |

 |(KAPLAN-MEIER)          |                                                                                                    |

 |                        |                                                                                                    |

 |SIGNIFICANCE (B)        |       P=0.008N           P=0.002N           P=0.029N           P=0.006N           P<0.001          |

 |(LIFE TABLE)            |                                                                                                    |

 |                        |                                                                                                    |

 |MEAN DAY OF             |       657.0              625.8              607.9              665.5              671.3            |

 |NATURAL DEATHS (C)      |       ( 9.7)             (19.7)             (41.1)             (14.4)             (27.2)           |

 |(STANDARD ERROR)        |                                                                                                    |

 |                        |                                                                                                    |

 |MEAN LIFE SPAN (D)      |       690.6              709.2              693.4              713.2              718.3            |

 |(STANDARD ERROR)        |       ( 7.4)             ( 7.1)             (14.4)             ( 5.4)             ( 6.2)           |

 |                        |                                                                                                    |

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

                                    


       (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)
                                                           ANTHRAQUINONE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        469 PPM          = 2

                                                        938 PPM          = 3

                                                        1875 PPM         = 4

                                                        3750 PPM         = 5



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



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



      |

      |

  100 +  1         5                             4         3                          21

      |            5                             4         3                 5        31 1     4

      |                                                                      5     5  2  1     1   3  4  2

      |                                                                            5   5       11     44

   92 +                                                                                5       51 13   4 242

      |                                                                                        5  11   5 3324  2

P     |                                                                                                5  5 44

E     |                                                                                                   3 3  22

R  84 +                                                                                            1   1    34432  2

C     |                                                                                                1  5 154  4

E     |                                                                                                      5 334 4

N     |                                                                                                     1 1    224

T  76 +                                                                                                       113  3 44

      |                                                                                                        11  32244

S     |                                                                                                         5   3 3

U     |

R  68 +                                                                                                         1  15533

V     |                                                                                                            1122334

I     |                                                                                                             112 32

V     |                                                                                                                  4 4

A  60 +                                                                                                              115 22

L     |                                                                                                               11

      |                                                                                                                  322

      |                                                                                                                    2 2

   52 +                                                                                                                151 3 34

      |                                                                                                                  11

      |                                                                                                                 551  1

      |                                                                                                                  5   22

   44 +                                                                                                                      11

      |

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

         0         9        18        27        36        45        54        63        72        81        90        99        108



                                                                   WEEK



NOTE: 29 obs hidden.
                                                           ANTHRAQUINONE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        469 PPM          = 2

                                                        938 PPM          = 3

                                                        1875 PPM         = 4

                                                        3750 PPM         = 5



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



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



      |

      |

  100 + 1             3                                                              5   2     1

      |               3                                                              5  32   5 1  12     4

      |                                                                                 3    5    11  2  4  4        55

      |                                                                                            1  2 1   44        5 5

P  90 +                                                                                           3     1 13 42

E     |                                                                                                    3 34    4    55

R     |                                                                                                   1 1313   2 424 55

C     |                                                                                                        3   3  2  2

E  80 +                                                                                                            3   3 24 2

N     |                                                                                                       11

T     |                                                                                                        1 1     3 33 4

      |                                                                                                          11

S  70 +                                                                                                           11      3 3

U     |

R     |                                                                                                            111

V     |                                                                                                              1 1

I  60 +

V     |

A     |                                                                                                                111

L     |

   50 +

      |

      |                                                                                                                  1  1

      |

   40 +

      |

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

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



                                                                   WEEK



NOTE: 24 obs hidden.