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TDMS Study 05217-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 03                                                                                     TIME: 07:17:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85219                              ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948-33-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96      
EXPERIMENT: 05217 TEST: 03                                                                                     TIME: 07:17:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85219                              ROUTE: DOSED FEED                                              NTP C#: C62157      
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948-33-0      
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 857 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 52     CENSORED DEATHS 10   TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      381   489   499   500   528   534   544   556   563   618                 |
 |      618   622   626   642   659   667   668   673   674   674                 |
 |      674   674   687   687   694   704   705   708   710   719                 |
 |      729   730   736   738   750   752   752   757   758   759                 |
 |      761   774   774   785   786   786   786   795   807   808                 |
 |      824   831                                                                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 48     CENSORED DEATHS 10   TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      375   577   591   613   613   617   620   625   638   651                 |
 |      655   661   667   672   673   675   691   694   701   702                 |
 |      712   715   719   722   722   730   735   749   757   758                 |
 |      762   765   786   807   810   810   814   821   827   829                 |
 |      830   831   837   837   839   841   850   852                             |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 53     CENSORED DEATHS 10   TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      289   373   394   467   535   535   547   554   562   564                 |
 |      583   619   634   647   655   656   662   666   667   668                 |
 |      677   682   684   684   697   697   697   702   708   708                 |
 |      722   722   725   729   730   730   730   744   744   745                 |
 |      761   765   766   768   773   786   786   808   814   830                 |
 |      831   852   852                                                           |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 857 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 68     UNCENSORED DEATHS 57     CENSORED DEATHS 10   TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      408   464   473   493   501   526   535   535   552   562                 |
 |      562   570   578   591   591   591   604   614   618   619                 |
 |      625   640   642   655   661   673   674   677   682   691                 |
 |      694   695   695   710   725   729   729   730   738   744                 |
 |      757   757   761   766   767   773   777   786   792   795                 |
 |      806   810   815   845   852   852   852                                   |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 46     CENSORED DEATHS 10   TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   487   487   508   520   537   551   589   603   621                 |
 |      626   626   626   627   632   642   647   647   647   655                 |
 |      668   675   682   691   702   702   708   719   730   730                 |
 |      730   739   745   745   750   766   767   773   773   786                 |
 |      786   806   807   808   810   839                                         |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 857 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   857 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0  98.3  98.3  88.3  85.0  75.0  13.3      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  95.0  80.0  20.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0  98.3  95.0  93.3  90.0  81.7  71.7  11.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0  98.3  94.8  86.2  70.7  56.9   1.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0  98.3  98.3  90.0  85.0  66.7  23.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 857 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                UNTREATD           0.0%               0.125%             0.25%              0.5%             |
 |                                CONTROL                                                                                      |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       13.3%              20.0%              11.7%               1.7%              23.3%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.842             -----             P=0.856            P=0.075            P=0.361N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       686.1              724.5              677.8              673.0              676.9            |
 |NATURAL DEATHS (C)      |       (13.8)             (13.8)             (16.2)             (14.6)             (14.6)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       620.7              656.9              612.1              590.2              629.4            |
 |(STANDARD ERROR)        |       (28.7)             (29.9)             (29.1)             (28.2)             (29.3)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

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

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 898 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 50     CENSORED DEATHS 10   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      297   302   380   418   421   497   540   540   546   578                 |
 |      579   613   627   628   638   640   649   661   690   694                 |
 |      704   712   722   724   733   733   736   758   761   765                 |
 |      765   766   777   778   785   789   795   795   796   799                 |
 |      802   808   830   831   854   855   856   879   880   888                 |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    93    93    93    93    93    93                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 38     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      351   408   509   523   600   601   633   648   648   668                 |
 |      708   717   729   733   738   738   744   756   775   777                 |
 |      788   802   810   810   817   817   825   830   831   849                 |
 |      858   859   859   861   863   865   885   890                             |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    93    93    93    93    93    93                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 49     CENSORED DEATHS 10   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      480   481   498   537   537   576   583   618   625   625                 |
 |      640   649   656   659   666   668   669   683   697   705                 |
 |      705   722   733   735   736   738   749   761   774   781                 |
 |      789   792   795   799   806   806   807   810   831   831                 |
 |      834   845   859   862   863   873   890   894   897                       |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    93    93    93    93    93    93                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 898 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 68     UNCENSORED DEATHS 42     CENSORED DEATHS 10   TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      197   425   498   578   600   613   632   649   657   658                 |
 |      661   666   667   682   703   721   738   757   758   767                 |
 |      767   772   772   774   774   788   789   789   799   801                 |
 |      816   817   817   845   856   860   883   883   888   890                 |
 |      891   894                                                                 |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    93    93    93    93    93    93                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 43     CENSORED DEATHS 10   TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      501   572   591   596   600   613   628   628   633   640                 |
 |      659   666   673   673   690   691   705   712   750   752                 |
 |      774   777   789   789   789   807   810   830   831   831                 |
 |      839   841   845   856   858   862   869   879   888   891                 |
 |      891   894   897                                                           |
 |  CENSORED DEATHS                                                               |
 |      93    93    93    93    93    93    93    93    93    93                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 898 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   898 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0  96.7  91.7  91.7  86.7  81.7  70.0  16.7      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0  98.3  96.7  96.7  93.3  90.0  85.0  36.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0 100.0 100.0  96.7  91.7  88.3  76.7  18.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0  98.3  98.3  96.6  96.6  94.8  91.4  81.0  27.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0 100.0 100.0  98.3  91.7  81.7  28.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 898 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                UNTREATD           0.0%               0.125%             0.25%              0.5%             |
 |                                CONTROL                                                                                      |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       16.7%              36.7%              18.3%              27.6%              28.3%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.356N            -----             P=0.564N           P=0.063N           P=0.030N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       692.3              740.1              725.9              733.1              751.4            |
 |NATURAL DEATHS (C)      |       (20.9)             (21.2)             (16.2)             (21.2)             (16.7)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       636.1              697.3              662.5              677.8              692.9            |
 |(STANDARD ERROR)        |       (31.7)             (32.9)             (31.1)             (33.5)             (32.1)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                        T-BUTYLHYDROQUINONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.0%             = 2
                                                        0.125%           = 3
                                                        0.25%            = 4
                                                        0.5%             = 5

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

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

             |
         100 +  1                               3        1  4 5
             |                                  3        1 34 5   44 11       2 2
             |                                             3      34 4 5        2 2
             |                                                    3  415511       22
          90 +                                                           411
             |                                                             111  55 222
             |                                                            44 1   5 1 22
             |                                                               3 3   35 22
          80 +                                                               44    11  22
             |                                                                4 4   113122
             |                                                                      55 11
             |                                                                  44   5531122
       P  70 +                                                                   444       22
       E     |                                                                        5533  22
       R     |                                                                     444  533  2
       C     |                                                                           11  22
       E  60 +                                                                       4 4  115
       N     |                                                                         4 4 11522
       T     |                                                                             311 22
             |                                                                           44 31 52 2
       S  50 +                                                                            4  131
       U     |                                                                            44   11 22 2
       R     |                                                                                33     2 2
       V     |                                                                             4 44 11 5
       I  40 +                                                                                44       22
       V     |                                                                                 33115    22
       A     |                                                                                 44  5 5
       L     |                                                                                  3 11 5 5
          30 +                                                                                  4 4      22
             |                                                                                     1 1
             |                                                                                    43 3 5  22
             |                                                                                     4 113  522
          20 +                                                                                     4 4113   2
             |                                                                                       44131
             |                                                                                        44 1  3
             |                                                                                           1  1
          10 +                                                                                         44
             |                                                                                          4  44
             |
             |                                                                                              4
           0 +
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 112 obs hidden.
                                                        T-BUTYLHYDROQUINONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.0%             = 2
                                                        0.125%           = 3
                                                        0.25%            = 4
                                                        0.5%             = 5

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

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

               |
               |
        106.67 +
               |
               |  1                     4         11    2     2       3 5       5
               |                        4          1       1  214     3 322 3   5 55
         93.33 +                                               11      14 2 3   3  25
               |                                                       1     1  33 2432 2
      P        |                                                             1  1    335242
      E        |                                                                1   1 33342    2
      R  80.00 +                                                                    1 1 3345   2 2
      C        |                                                                      11 3354 4  22
      E        |                                                                       1113 3 44  22
      N        |                                                                         1  1135  4242
      T  66.67 +                                                                             1113  542 22
               |                                                                               113   4 522
      S        |                                                                                113    5 22
      U        |                                                                                 11 14 4 522
      R  53.33 +                                                                                    11344  2  2
      V        |                                                                                      333  5552
      I        |                                                                                     11 3 4  55
      V        |                                                                                      11334  422
      A  40.00 +                                                                                       11    442522
      L        |                                                                                        13 3  4  422
               |                                                                                        11 333   44
               |                                                                                         1 1 333  55
         26.67 +                                                                                           1  133 44
               |                                                                                              1 313
               |                                                                                                 133
               |                                                                                                 1 1
         13.33 +
               |
               ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                  0             20             40             60             80             100            120            140

                                                                     WEEK

NOTE: 106 obs hidden.