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TDMS Study 05197-12 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 08/23/99       

EXPERIMENT: 05197 TEST: 12                                                                                     TIME: 11:23:21       

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

CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D       

PATHOLOGIST: MILLER, RODNEY                                                                                    CAS: 111-76-0002     

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

                                                                                                                                    

                                                        FINAL#1, REVISION #1                                                        

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

LAB: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 08/23/99      

EXPERIMENT: 05197 TEST: 12                                                                                     TIME: 11:23:21      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D      

PATHOLOGIST: MILLER, RODNEY                                                                                    CAS: 111-76-0002    
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      374   459   556   561   565   618   621   642   663   667                 |

 |      669                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 62.5 PPM                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      549   611   621   649   656   670   681   681   701   705                 |

 |      707                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 125 PPM                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      421   430   457   502   511   537   563   567   582   583                 |

 |      583   585   597   600   618   647   655   663   670   681                 |

 |      698   704   705                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 250 PPM                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      73    312   368   374   402   442   454   596   604   613                 |

 |      614   623   629   638   663   665   670   670   684   684                 |

 |      694   694   702   711                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   729 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  90.0  82.0  78.0      |

 |           |                                                                    |

 |           |                                                                    |

 |62.5 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  78.0      |

 |           |                                                                    |

 |           |                                                                    |

 |125 PPM    |   100.0 100.0 100.0 100.0  98.0  94.0  88.0  72.0  64.0  54.0      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPM    |    98.0  98.0  98.0  96.0  90.0  86.0  86.0  82.0  68.0  52.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      62.5 PPM     125 PPM      250 PPM  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       78.0%        78.0%        54.0%        52.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.001      P=1.000N     P=0.021      P=0.015  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       581.4        657.4        589.5        565.8    |

 |NATURAL DEATHS (C)      |       (28.2)       (14.5)       (17.6)       (32.9)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       696.5        713.2        664.8        650.7    |

 |(STANDARD ERROR)        |       (10.6)       ( 5.2)       (12.7)       (19.5)   |

 |                        |                                                       |

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

                                    


       (A)  FIRST TERMINAL SACRIFICE

       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.

            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS

            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".

       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE

       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 1    TERMINAL 29        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      376   521   561   565   572   577   586   590   606   611                 |

 |      621   645   649   689   700   713   715   715   721   730                 |

 |  CENSORED DEATHS                                                               |

 |      725                                                                       |

 |                                                                                |

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

 |                                DOSE = 62.5 PPM                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      255   369   372   456   472   534   544   592   604   606                 |

 |      647   670   672   676   694   712   712   715   723                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 125 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      72    196   397   408   456   537   544   570   572   591                 |

 |      627   666   698   715   723   723   723                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 250 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      437   485   489   529   582   582   618   621   653   656                 |

 |      656   660   682   708                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  2-BUTOXYETHANOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   731 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  84.0  74.0  59.9      |

 |           |                                                                    |

 |           |                                                                    |

 |62.5 PPM   |   100.0 100.0  98.0  98.0  94.0  90.0  86.0  82.0  78.0  62.0      |

 |           |                                                                    |

 |           |                                                                    |

 |125 PPM    |    98.0  98.0  96.0  96.0  92.0  90.0  86.0  80.0  78.0  66.0      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  76.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      62.5 PPM     125 PPM      250 PPM  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       59.9%        62.0%        66.0%        72.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.254N     P=1.000N     P=0.741N     P=0.324N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       623.2        580.3        542.2        597.0    |

 |NATURAL DEATHS (C)      |       (19.5)       (31.6)       (45.6)       (22.2)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       687.7        673.7        666.8        693.5    |

 |(STANDARD ERROR)        |       (10.7)       (15.8)       (19.9)       (10.5)   |

 |                        |                                                       |

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

                                    


       (A)  FIRST TERMINAL SACRIFICE

       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.

            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS

            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".

       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE

       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                          2-BUTOXYETHANOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        62.5 PPM         = 2

                                                        125 PPM          = 3

                                                        250 PPM          = 4



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



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



      |

      |

  104 +

      |

      | 1           4                                              1       3                   2

      |             4                                     4        1       33    1             2         2

   96 +                                                   4       4         3    1              1        22

      |                                                           44             3     3        11        2   2

P     |                                                            4    4              33                     22

E     |                                                                 4     4         3    3   1        1    2  2

R  88 +                                                                       4 4            3   3                2 2

C     |                                                                         4                      4  1  1

E     |                                                                                          3  3  44    1   1  2  2

N     |                                                                                                 44       11

T  80 +

      |                                                                                                  44       1    2    1

S     |                                                                                             3  3  44

U     |                                                                                                    4 4

R  72 +                                                                                                3  3  4   4

V     |                                                                                                   3   3

I     |                                                                                                       33 44

V     |                                                                                                        3 3

A  64 +                                                                                                          33 4

L     |                                                                                                           3 3

      |                                                                                                             3 3

      |                                                                                                               33

   56 +                                                                                                               44

      |                                                                                                                34   3

      |                                                                                                                 4   4

      |

   48 +

      |

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

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



                                                                   WEEK



NOTE: 9 obs hidden.
                                                          2-BUTOXYETHANOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        62.5 PPM         = 2

                                                        125 PPM          = 3

                                                        250 PPM          = 4



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



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



      |

      |

  100 + 1           3                            2                 1         4

      |

      |             3                  3         2                21         4       4     1

      |                                3                          22   3                   1     1

   95 +

      |                                                            2   3 3       2   4      4

      |                                                                  3       2 2        4    11 4

      |

P  90 +                                                                          3 2         2    11

E     |

R     |                                                                                      22    11     4

C     |                                                                                       2   3 1 1

E  85 +

N     |                                                                                               1 1 4    4

T     |                                                                                           3   3 11

      |

S  80 +                                                                                               3 2113  2

U     |

R     |                                                                                                   13  14 42

V     |                                                                                                          43 4 3

I  75 +

V     |                                                                                                       1   22413 43

A     |                                                                                                            2 11 433 4

L     |

   70 +                                                                                                               1 1

      |

      |                                                                                                                 11

      |                                                                                                                 223 3

   65 +

      |                                                                                                                  22

      |                                                                                                                  12 1

      |

   60 +                                                                                                                     1

      |

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

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



                                                                   WEEK



NOTE: 18 obs hidden.