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TDMS Study 05094-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 02                                                                                     TIME: 07:26:55       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C       
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96      
EXPERIMENT: 05094 TEST: 02                                                                                     TIME: 07:26:55      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85222                              ROUTE: DOSED FEED                                              NTP C#: 54375C      
PATHOLOGIST: DR J. E. HEATH                                                                                    CAS: 85-68-7        
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      255   261   438   477   479   541   544   557   562   576                 |
 |      593   607   611   614   631   631   644   662   677   717                 |
 |      718   718                                                                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = CONTROL FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      339   422   451   479   499   584   607   639   649   654                 |
 |      669   678   702   719   722   722                                         |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.3%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 30     CENSORED DEATHS 10   TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      303   450   477   499   499   519   541   544   550   565                 |
 |      569   584   586   601   607   607   607   611   626   627                 |
 |      644   645   649   678   694   698   708   708   723   723                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      400   494   542   542   569   574   592   611   614   628                 |
 |      651   655   670   674   681   681   683   684   697   697                 |
 |      701   702   702   703   708   717   722   723                             |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.2%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      180   297   464   466   477   550   593   614   634   639                 |
 |      639   654   662   663   668   674   674   675   684   698                 |
 |      698   703   709   709   716   716   716   718                             |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0  96.7  96.7  96.7  91.0  86.9  78.8  64.7  56.6      |
 |U          |                                                                    |
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.3  96.6  92.9  90.8  88.7  80.5  68.1      |
 |FEED RTD   |                                                                    |
 |           |                                                                    |
 |0.3%       |   100.0 100.0 100.0  98.3  98.3  94.7  84.6  72.5  54.4  40.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.6%       |   100.0 100.0 100.0 100.0  98.3  98.3  92.3  86.3  76.3  44.1      |
 |           |                                                                    |
 |           |                                                                    |
 |1.2%       |   100.0  98.3  98.3  96.7  96.7  90.6  90.6  86.6  72.5  44.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                UNTREATDCONTROL    CONTROL            0.3%               0.6%               1.2%             |
 |                                U                  FEED RTD                                                                  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.6%              68.1%              40.3%              44.1%              44.3%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.140             -----             P=0.185            P=0.570            P=0.520          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       568.8              595.9              594.7              643.5              617.5            |
 |NATURAL DEATHS (C)      |       (26.9)             (30.2)             (16.9)             (14.9)             (24.8)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       625.1              647.0              616.7              643.9              631.8            |
 |(STANDARD ERROR)        |       (16.7)             (15.7)             (14.7)             (13.8)             (16.6)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      39    368   512   570   587   598   668   670   681   684                 |
 |      691   702   702   703   711   713   716   717   717   717                 |
 |      719   725   725   725   726                                               |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = CONTROL FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      225   491   551   586   721   722   722   731   733                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      247   405   424   529   593   606   606   611   618   663                 |
 |      682   689   701   703   718   722   725   725   725   725                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.2%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      285   479   509   544   544   551   572   607   646   647                 |
 |      647   666   670   703   722   724   725   725   726   726                 |
 |      733                                                                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.4%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      404   452   452   452   487   487   551   592   607   607                 |
 |      611   681   684   684   684   703   703   703   717   722                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL 98.3  98.3  98.3  98.3  96.7  96.7  94.7  88.6  88.6  50.3      |
 |U          |                                                                    |
 |           |                                                                    |
 |CONTROL    |   100.0 100.0  98.3  98.3  98.3  98.3  96.3  92.3  92.3  82.3      |
 |FEED RTD   |                                                                    |
 |           |                                                                    |
 |0.6%       |   100.0 100.0  98.3  98.3  95.0  95.0  93.0  91.0  80.9  58.6      |
 |           |                                                                    |
 |           |                                                                    |
 |1.2%       |   100.0 100.0 100.0  98.3  98.3  96.3  90.3  86.3  78.3  58.2      |
 |           |                                                                    |
 |           |                                                                    |
 |2.4%       |   100.0 100.0 100.0 100.0  98.3  93.3  89.3  85.2  79.1  58.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                UNTREATDCONTROL    CONTROL            0.6%               1.2%               2.4%             |
 |                                U                  FEED RTD                                                                  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       50.3%              82.3%              58.6%              58.2%              58.8%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.245             -----             P=0.567N           P=0.596N           P=0.759N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       643.4              609.1              625.9              626.2              605.1            |
 |NATURAL DEATHS (C)      |       (30.3)             (57.0)             (28.1)             (24.6)             (23.7)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       651.3              670.8              651.3              651.4              644.0            |
 |(STANDARD ERROR)        |       (17.6)             (15.9)             (16.1)             (15.5)             (15.5)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                                       BUTYL BENZYL PHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        CONTROL FEED RTD = 2
                                                        0.3%             = 3
                                                        0.6%             = 4
                                                        1.2%             = 5

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

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

      |
      |
  100 + 1                            5           1      3     2         4
      |                              5           11    53     2         4  2 1  2 5 3 4       4
      |                                                                      1  2   1  3
      |                                                                           5 2  2      4   4
P  90 +                                                                             1  2   3  15    2
E     |                                                                                    3  151 4 2 4 24   2
R     |                                                                                       3311       5  522
C     |                                                                                        3 1 1     4 45522
E  80 +                                                                                          331  1 1  4  42  2
N     |                                                                                           3 3   11   544 522   2
T     |                                                                                             3  3          44   2 2
      |                                                                                                331  1    5544    22
S  70 +                                                                                                           55
U     |                                                                                                 33  11   1        2 2
R     |                                                                                                  3 3     1 14 4
V     |                                                                                                            15 5  1
I  60 +                                                                                                    3 3        44
V     |                                                                                                      33       5551  1
A     |                                                                                                       3    3
L     |                                                                                                            3  3445
   50 +                                                                                                                 44
      |                                                                                                               3 344
      |                                                                                                                 353 4
      |
   40 +                                                                                                                   3 3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 35 obs hidden.
                                                       BUTYL BENZYL PHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        CONTROL FEED RTD = 2
                                                        0.6%             = 3
                                                        1.2%             = 4
                                                        2.4%             = 5

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

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

      |
  100 + 1      1                            2   3    4                  5
      |        1                            2   3    4            1     3       5   4 2
      |
      |                                                           1     3  3        4 2 41     2
   95 +                                                                    3             1  3     1
      |                                                                         5    5  4     42    2
      |                                                                                     3     1 1 3                  2
      |                                                                                             1 313
   90 +                                                                                       44                         22
      |                                                                              5         4  4    1          1
      |                                                                                        5      5 33
      |                                                                                           4     4                 2 2
P  85 +                                                                                               5 533       1 1
E     |                                                                                                 4     4
R     |                                                                                                   3      3          22
C     |                                                                                                 55       3  3
E  80 +                                                                                                             11
N     |                                                                                                  5    4   4 31 1
T     |
      |                                                                                                              3 3
S  75 +
U     |                                                                                                           4    4
R     |                                                                                                                1134
V     |                                                                                                             5  5 33
I  70 +
V     |                                                                                                                 11
A     |
L     |
   65 +                                                                                                                5 5
      |
      |                                                                                                                  55
      |
   60 +                                                                                                                   4 4
      |                                                                                                                  11 43
      |
      |
   55 +
      |
      |
      |
   50 +                                                                                                                   1  1
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.