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TDMS Study 05094-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                              BUTYL BENZYL PHTHALATE                                DATE: 04/03/96       
EXPERIMENT: 05094 TEST: 03                                                                                     TIME: 18:24:07       
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: 03                                                                                     TIME: 18:24:07      
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 897 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 110    UNCENSORED DEATHS 55     CENSORED DEATHS 45   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      432   467   507   516   549   569   583   597   600   617                 |
 |      617   619   645   645   655   656   661   667   670   681                 |
 |      682   682   696   698   701   703   709   710   719   719                 |
 |      719   723   723   730   740   744   746   754   755   757                 |
 |      761   768   777   785   785   796   796   798   798   813                 |
 |      823   824   839   868   893                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      729   729   729   729   729   729   729   729   729   729                 |
 |      729   729   729   729   729   729   729   729   729   729                 |
 |      729   729   729   729   729   729   729   729   729   729                 |
 |      729   729   729   729   729                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.2%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 110    UNCENSORED DEATHS 56     CENSORED DEATHS 41   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      54    90    350   498   499   508   521   530   536   540                 |
 |      579   589   589   605   610   619   619   628   633   634                 |
 |      635   641   663   667   669   674   674   675   677   684                 |
 |      687   698   709   715   716   719   723   723   723   737                 |
 |      737   737   755   775   785   796   798   806   807   807                 |
 |      827   844   844   844   869   876                                         |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      729   729   729   729   729   729   729   729   729   729                 |
 |      730   730   730   730   730   730   730   730   730   730                 |
 |      730   730   730   730   730   730   730   730   730   730                 |
 |      730                                                                       |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 897 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   897 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0  98.1  96.1  91.1  83.1  21.0      |
 |U          |                                                                    |
 |           |                                                                    |
 |1.2%       |    98.2  98.2  98.2  97.3  97.3  97.3  90.3  86.2  77.2  26.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                UNTREATDCONTROL           1.2%                  |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       21.0%                     26.5%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000                   P=1.000               |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       699.8                     659.8                 |
 |NATURAL DEATHS (C)      |       (13.2)                    (21.0)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       704.9                     689.1                 |
 |(STANDARD ERROR)        |       (11.3)                    (14.6)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 977 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 110    UNCENSORED DEATHS 55     CENSORED DEATHS 45   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      324   358   359   478   498   498   551   564   573   597                 |
 |      616   624   625   649   649   674   677   683   684   685                 |
 |      687   687   687   687   694   696   702   705   705   712                 |
 |      722   740   744   747   750   754   754   793   796   816                 |
 |      823   829   844   844   858   872   900   914   915   922                 |
 |      928   949   967   970   971                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      730   730   730   730   730   730   730   730   730   730                 |
 |      730   730   730   730   730   730   730   730   730   730                 |
 |      730   731   731   731   731   731   731   731   731   731                 |
 |      731   731   731   731   731                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.4%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 110    UNCENSORED DEATHS 50     CENSORED DEATHS 49   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      428   498   530   592   600   634   634   652   652   667                 |
 |      677   683   684   684   696   705   715   715   716   719                 |
 |      719   731   737   740   740   775   779   796   806   813                 |
 |      824   832   838   838   845   845   858   871   872   885                 |
 |      886   907   907   927   928   936   936   970   971   971                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      730   730   730   730   730   731   731   731   731   731                 |
 |      731   731   731   731   731   731   731   731   731   731                 |
 |      731   731   731   731   731   731   731   731   731   731                 |
 |      731   731   731   731   731   731   731   731   731                       |
 |                                                                                |
 ==================================================================================
                              BUTYL BENZYL PHTHALATE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 977 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   977 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0  97.3  97.3  96.3  94.3  90.3  85.2  20.4      |
 |U          |                                                                    |
 |           |                                                                    |
 |2.4%       |   100.0 100.0 100.0 100.0 100.0  99.1  97.1  95.1  91.1  22.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                UNTREATDCONTROL           2.4%                  |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       20.4%                     22.0%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.303N                  P=0.303N              |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       717.3                     767.3                 |
 |NATURAL DEATHS (C)      |       (20.7)                    (18.0)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       721.4                     747.1                 |
 |(STANDARD ERROR)        |       (14.8)                    (13.7)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                       BUTYL BENZYL PHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        1.2%             = 2

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

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

             |
             |
         100 +  1     2   2                                    1  1
             |            2                           2           1   211
             |                                                        221  1  11
             |                                                          2222   1 1
          90 +                                                             2  2 21 1
             |                                                                  22 1  1
             |                                                                   222  11
             |                                                                     22  11
       P  80 +                                                                      22  1 1
       E     |                                                                       2 22 11
       R     |                                                                          22 111
       C     |                                                                               1
       E  70 +                                                                           222 11
       N     |                                                                             2 211
       T     |                                                                               2211
             |                                                                                  1
       S  60 +                                                                                2 2
       U     |                                                                                  11
       R     |                                                                                  211
       V     |                                                                                   2 2
       I  50 +                                                                                    11 22
       V     |                                                                                     1
       A     |                                                                                     1 122
       L     |                                                                                       11
          40 +
             |                                                                                         2 2 2
             |
             |                                                                                        1 11
          30 +                                                                                             2  2
             |                                                                                           11   22 2
             |                                                                                            1  1
             |                                                                                               1  1
          20 +                                                                                                  11
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 33 obs hidden.
                                                       BUTYL BENZYL PHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        2.4%             = 2

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

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

             |
             |
         100 +  1                                  1   1       2      2
             |                                         1            1 1  2      2
             |                                                        1    1    22  2
             |                                                             1 11  1  2  2
          90 +                                                                   11 1  2222
             |                                                                      1 1
             |                                                                        1  12222
             |                                                                           11
       P  80 +                                                                            1  2 2
       E     |                                                                                 22
       R     |                                                                            111
       C     |                                                                                  2  2
       E  70 +                                                                              111 1  22
       N     |                                                                                  1   2 2
       T     |                                                                                        222
             |                                                                                  11      22
       S  60 +                                                                                           2
       U     |                                                                                   1    1  22
       R     |                                                                                            22
       V     |                                                                                        1 1
       I  50 +                                                                                          11 22
       V     |                                                                                           1 12 2
       A     |                                                                                                22
       L     |                                                                                             11
          40 +                                                                                              1 12  2
             |                                                                                                1  11
             |                                                                                                    2 2
             |                                                                                                    1122
          30 +                                                                                                     11
             |                                                                                                      121 1
             |
             |                                                                                                          22
          20 +                                                                                                          11
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 26 obs hidden.