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TDMS Study 05165-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                              4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)                           DATE: 11/09/95       
EXPERIMENT: 05165 TEST: 01                                                                                     TIME: 20:00:58       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65156                              ROUTE: DOSED FEED                                              NTP C#: 61610B       
PATHOLOGIST: J. TOFT                                                                                           CAS: 96-69-5         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                              4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)                           DATE: 11/09/95      
EXPERIMENT: 05165 TEST: 01                                                                                     TIME: 20:00:58      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-65156                              ROUTE: DOSED FEED                                              NTP C#: 61610B      
PATHOLOGIST: J. TOFT                                                                                           CAS: 96-69-5        
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 32     CENSORED DEATHS 0    TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      312   418   443   467   517   530   533   547   564   579                 |
 |      589   596   605   619   621   625   625   625   632   632                 |
 |      633   648   656   660   663   676   678   688   688   723                 |
 |      725   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 PPM    65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      449   449   449   449   449   449   449   449   449   449                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      352   416   452   488   505   513   589   610   625   642                 |
 |      649   649   650   663   669   673   676   677   695   708                 |
 |      712   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 500 PPM  65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      449   449   449   449   449   449   449   449   449   449                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      416   450   466   477   555   561   592   599   604   610                 |
 |      627   633   639   650   652   653   660   688   688   688                 |
 |      695   697   698   703   709   719   723   725                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1000 PPM 65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 3      CENSORED DEATHS 7    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      403   410   410                                                           |
 |  CENSORED DEATHS                                                               |
 |      449   449   449   449   449   449   449                                   |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 32     CENSORED DEATHS 0    TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   441   484   533   539   555   555   555   566   571                 |
 |      576   603   604   604   621   625   633   645   649   649                 |
 |      649   652   656   663   673   677   677   695   695   698                 |
 |      712   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 2500 PPM 65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      449   449   449   449   449   449   449   449   449   449                 |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.0  96.0  92.0  86.0  74.0  50.0  36.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM    65 P|TH                                                                  |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0  98.0  96.0  94.0  88.0  86.0  72.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500        |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM  65 PAT|                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.0  92.0  92.0  82.0  66.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0 100.0 100.0  70.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM 65 PATH|                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  90.0  72.0  52.0  36.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM 65 PATH|                                                                    |
 |           |                                                                    |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0 PPM       0           500 PPM     500         1000 PPM    1000        2500 PPM    2500     |
 |                                            PPM    65 PA H          PPM  65 PATH            PPM 65 PATH             PPM 65 PA|H
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       36.0%        0.0%       56.0%        0.0%       44.0%        0.0%       36.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.506      -----      P=0.049N    P=0.989N    P=0.303N    P=0.066     P=1.000N    P=0.989N |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       601.3          .        606.3          .        627.8       407.7       612.5          .     |
 |NATURAL DEATHS (C)      |       (16.6)      (  . )      (22.3)      (  . )      (16.5)      ( 2.3)      (13.3)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       647.3       449.0       675.0       449.0       672.3       436.6       654.5       449.0    |
 |(STANDARD ERROR)        |       (13.7)      ( 0.0)      (13.0)      ( 0.0)      (11.6)      ( 6.3)      (11.6)      ( 0.0)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      453   518   536   623   651   663   673   673   673   676                 |
 |      709   715   721   725   725   728                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 PPM    65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   450   450   450                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   428   590   591   604   605   624   626   652   663                 |
 |      665   677   677   688   688   688   697   712   725                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 500 PPM  65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   450   450   450                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      14    481   539   555   592   598   598   626   633   649                 |
 |      680   688   688   695   695   712   723   723                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1000 PPM 65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   450   450   450                 |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      452   491   518   541   572   572   591   597   604   605                 |
 |      620   641   660   663   663   688   688   697   698   711                 |
 |      715   719                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 2500 PPM 65 PATH                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   450   450   450                 |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  94.0  88.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM    65 P|TH                                                                  |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  88.0  78.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500        |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM  65 PAT|                                                                    |
 |           |                                                                    |
 |1000 PPM   |    98.0  98.0  98.0  98.0  98.0  96.0  94.0  86.0  80.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM 65 PATH|                                                                    |
 |           |                                                                    |
 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  80.0  70.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2500       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM 65 PATH|                                                                    |
 |           |                                                                    |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0 PPM       0           500 PPM     500         1000 PPM    1000        2500 PPM    2500     |
 |                                            PPM    65 PA H          PPM  65 PATH            PPM 65 PATH             PPM 65 PA|H
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.0%        0.0%       62.0%        0.0%       64.0%        0.0%       56.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.202      -----      P=0.558      -----      P=0.711      -----      P=0.195      -----   |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       653.9          .        630.1          .        604.9          .        623.0          .     |
 |NATURAL DEATHS (C)      |       (20.6)      (  . )      (20.9)      (  . )      (38.3)      (  . )      (16.2)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       705.0       450.0       691.4       450.0       684.3       450.0       682.4       450.0    |
 |(STANDARD ERROR)        |       ( 8.2)      ( 0.0)      (10.4)      ( 0.0)      (16.0)      ( 0.0)      (10.3)      ( 0.0)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                                                  4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        0 PPM    65 PATH = 2
                                                        500 PPM          = 3
                                                        500 PPM  65 PATH = 4
                                                        1000 PPM         = 5
                                                        1000 PPM 65 PATH = 6
                                                        2500 PPM         = 7
                                                        2500 PPM 65 PATH = 8

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

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

      |
      |
  100 + 1                                                 1     3       6 17 7  2
      |                                                                   1  71 3 1 53       7
P     |                                                                 66        1 53  31  11  55    3
E     |                                                                                      1 171    3553 3
R  80 +                                                                                          171  1155 3533
C     |                                                                                                11 1 553  3
E     |                                                                  6      6                       7 117 55 333
N     |                                                                                                    11 7  5 3 53
T  60 +                                                                                                     1 17     53 3 3
      |                                                                                                       11 1    55  3 3
S     |                                                                                                          1 1   5555
U     |                                                                                                            1 17   5 5
R  40 +                                                                                                              17 7 1
V     |                                                                                                                   1 1
I     |
V     |
A  20 +
L     |
      |
      |
    0 +                                                                         2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 79 obs hidden.
                                                  4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        0 PPM    65 PATH = 2
                                                        500 PPM          = 3
                                                        500 PPM  65 PATH = 4
                                                        1000 PPM         = 5
                                                        1000 PPM 65 PATH = 6
                                                        2500 PPM         = 7
                                                        2500 PPM 65 PATH = 8

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

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

      |
      |
  100 + 1 5                                                        3        3   1   5 7  1
      |                                                                     3       5 7  1   17 5     3   1
P     |                                                                                       7 5 7   353 13  1  1 1
E     |                                                                                               757  35  3
R  80 +                                                                                                 7 7 5753 3 155  11
C     |                                                                                                      7   7 3 35  11
E     |                                                                                                          7   33 5 1 1
N     |                                                                                                              73 3 3 5
T  60 +                                                                                                               7 773 3
      |                                                                                                                  7  7
S     |
U     |
R  40 +
V     |
I     |
V     |
A  20 +
L     |
      |
      |
    0 +                                                                         2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 50 obs hidden.
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                              4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)                           DATE: 11/09/95       
EXPERIMENT: 05165 TEST: 03                                                                                     TIME: 21:05:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65156                              ROUTE: DOSED FEED                                              NTP C#: 61610B       
PATHOLOGIST: J. TOFT                                                                                           CAS: 96-69-5         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                              4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)                           DATE: 11/09/95      
EXPERIMENT: 05165 TEST: 03                                                                                     TIME: 21:05:21      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-65156                              ROUTE: DOSED FEED                                              NTP C#: 61610B      
PATHOLOGIST: J. TOFT                                                                                           CAS: 96-69-5        
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0 PPM    NEURO                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 0      CENSORED DEATHS 40   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      99    99    99    99    99    99    100   100   100   100                 |
 |      100   100   102   103   106   107   108   109   110   113                 |
 |      183   184   185   186   190   190   190   190   190   190                 |
 |      191   191   191   191   191   191   193   194   197   198                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 PPM    HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 15   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 500 PPM  NEURO                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 0      CENSORED DEATHS 40   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      99    99    99    99    99    99    100   100   100   100                 |
 |      100   100   102   103   106   107   108   109   110   113                 |
 |      183   184   185   186   190   190   190   190   190   190                 |
 |      191   191   191   191   191   192   193   194   197   198                 |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 500 PPM  HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 15   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456   456                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1000 PPM NEURO                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 0      CENSORED DEATHS 40   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      99    99    99    99    99    99    100   100   100   100                 |
 |      100   100   102   103   106   107   108   109   110   113                 |
 |      183   184   185   186   190   190   190   190   190   190                 |
 |      191   191   191   191   191   192   193   194   197   198                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1000 PPM HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 12   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      250   277   368                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456                                                                 |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 2500 PPM NEURO                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 40     UNCENSORED DEATHS 0      CENSORED DEATHS 40   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      99    99    99    99    99    99    100   100   100   100                 |
 |      100   100   102   103   106   107   108   109   110   113                 |
 |      183   184   185   186   190   190   190   190   190   190                 |
 |      191   191   191   191   191   192   193   194   197   198                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 2500 PPM HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 14   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      330                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      456   456   456   456                                                     |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   1E5 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM    NEUR|                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |PPM    HCU |                                                                    |
 |           |                                                                    |
 |500        |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM  NEURO |                                                                    |
 |           |                                                                    |
 |500        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |PPM  HCU   |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM NEURO  |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0  93.3  86.7  80.0  80.0  80.0  80.0  80.0  80.0      |
 |PPM HCU    |                                                                    |
 |           |                                                                    |
 |2500       |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |PPM NEURO  |                                                                    |
 |           |                                                                    |
 |2500       |   100.0 100.0 100.0  93.3  93.3  93.3  93.3  93.3  93.3  93.3      |
 |PPM HCU    |                                                                    |
 |           |                                                                    |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0           0           500         500         1000        1000        2500        2500     |
 |                                PPM    NEUROPPM    HCU  PPM  NEURO  PPM  HCU    PPM NEURO   PPM HCU     PPM NEURO   PPM HCU  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|        0.0%      100.0%        0.0%      100.0%        0.0%       80.0%        0.0%       93.3%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.680      -----       -----       -----       -----      P=1.000N     -----       -----   |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |          .           .           .           .           .        298.3          .        330.0    |
 |NATURAL DEATHS (C)      |       (  . )      (  . )      (  . )      (  . )      (  . )      (35.7)      (  . )      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       146.5       456.0       146.5       456.0       146.5       424.5       146.5       447.6    |
 |(STANDARD ERROR)        |       ( 7.1)      ( 0.0)      ( 7.1)      ( 0.0)      ( 7.1)      (17.9)      ( 7.1)      ( 8.4)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0 PPM    HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 15   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 500 PPM  HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 15   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1000 PPM HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 15   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457   457                                               |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 2500 PPM HCU                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 14   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      218                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      457   457   457   457                                                     |
 |                                                                                |
 ==================================================================================
                         4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 99999 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   1E5 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |PPM    HCU |                                                                    |
 |           |                                                                    |
 |500        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |PPM  HCU   |                                                                    |
 |           |                                                                    |
 |1000       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |PPM HCU    |                                                                    |
 |           |                                                                    |
 |2500       |   100.0 100.0  93.3  93.3  93.3  93.3  93.3  93.3  93.3  93.3      |
 |PPM HCU    |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            500          1000         2500     |
 |                                PPM    HCU   PPM  HCU     PPM HCU      PPM HCU  |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|      100.0%       100.0%       100.0%        93.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.423       -----        -----       P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |          .            .            .         218.0    |
 |NATURAL DEATHS (C)      |       (  . )       (  . )       (  . )       (  . )   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       457.0        457.0        457.0        441.1    |
 |(STANDARD ERROR)        |       ( 0.0)       ( 0.0)       ( 0.0)       (15.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                  4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM    NEURO   = 1
                                                        0 PPM    HCU     = 2
                                                        500 PPM  NEURO   = 3
                                                        500 PPM  HCU     = 4
                                                        1000 PPM NEURO   = 5
                                                        1000 PPM HCU     = 6
                                                        2500 PPM NEURO   = 7
                                                        2500 PPM HCU     = 8

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

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

      |
      |
  100 +  1                                                              1                    8                               2
      |                                                                 6      6             8                               8
P     |
E     |                                                                        6                      6
R  80 +                                                                                               6                      6
C     |
E     |
N     |
T  60 +
      |
S     |
U     |
R  40 +
V     |
I     |
V     |
A  20 +
L     |
      |
      |
    0 +                                                                 1
      |
      ---+------+------+------+------+------+------+------+------+------+------+------+------+------+------+------+------+------+--
         0      4      8     12     16     20     24     28     32     36     40     44     48     52     56     60     64     68

                                                                   WEEK

NOTE: 15 obs hidden.
                                                  4,4 THIOBIS-(6-T-BUTYL-M-CRESOL)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM    HCU     = 1
                                                        500 PPM  HCU     = 2
                                                        1000 PPM HCU     = 3
                                                        2500 PPM HCU     = 4

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

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.
                (NOTE: 5 obs hidden.)
      P        |
      E        |
      R 100.00 +  1                                               4                                                  1
      C        |
      E        |
      N        |
      T  93.33 +                                                  4                                                  4
               |
      S        ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
      U           0             10             20             30             40             50             60             70
      R
                                                                     WEEK