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TDMS Study 60968-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                     ISOBUTYRALDEHYDE                                   DATE: 08/06/96       
EXPERIMENT: 60968 TEST: 01                                                                                     TIME: 17:18:06       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95241                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 60968B       
PATHOLOGIST: R. RENNE                        RENNE, R.                                                         CAS: 0078-84-2       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                     ISOBUTYRALDEHYDE                                   DATE: 08/06/96      
EXPERIMENT: 60968 TEST: 01                                                                                     TIME: 17:18:06      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95241                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 60968B      
PATHOLOGIST: R. RENNE                        RENNE, R.                                                         CAS: 0078-84-2      
                                 ISOBUTYRALDEHYDE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 38     CENSORED DEATHS 0    TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      259   421   433   465   482   523   547   549   556   566                 |
 |      574   579   580   604   608   608   614   618   636   642                 |
 |      651   663   663   664   678   678   678   681   685   687                 |
 |      692   695   698   705   706   706   720   729                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      184   384   403   540   554   575   579   580   594   601                 |
 |      605   608   614   614   616   616   618   635   636   644                 |
 |      663   664   667   667   674   678   679   679   687   687                 |
 |      692   706   715   716   728                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 39     CENSORED DEATHS 0    TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      419   440   468   468   479   486   489   502   520   523                 |
 |      538   539   541   552   568   576   578   580   586   590                 |
 |      601   607   616   617   625   636   636   650   664   666                 |
 |      679   686   692   700   701   706   715   720   720                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 40     CENSORED DEATHS 0    TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   443   463   465   468   491   494   496   520   545                 |
 |      552   576   579   580   581   582   590   607   615   624                 |
 |      632   636   636   636   637   638   638   645   650   652                 |
 |      652   658   660   664   678   679   680   684   720   723                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0  98.0  98.0  96.0  90.0  88.0  72.0  52.0  24.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0  98.0  98.0  94.0  94.0  92.0  78.0  56.0  30.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.0  90.0  74.0  58.0  42.0  22.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0 100.0 100.0  90.0  80.0  66.0  32.0  20.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      1000 PPM     2000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       24.0%        30.0%        22.0%        20.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.171      P=0.618N     P=0.561      P=0.323  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       611.7        614.3        591.8        597.8    |
 |NATURAL DEATHS (C)      |       (16.2)       (17.9)       (13.7)       (12.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       640.8        649.9        622.8        624.8    |
 |(STANDARD ERROR)        |       (14.3)       (14.7)       (13.6)       (12.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      56    400   428   447   448   496   547   547   561   580                 |
 |      580   616   617   623   625   678   679   687   690   692                 |
 |      695   720   725                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 1    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      511   524   544   551   552   575   591   608   624   636                 |
 |      636   640   642   663   678   678   681   687   692   695                 |
 |      701   701   705   706   712                                               |
 |  CENSORED DEATHS                                                               |
 |      71                                                                        |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      487   489   508   580   608   614   636   637   656   664                 |
 |      664   677   681   685   687   687   692   692   696   701                 |
 |      706   706   706   706   720   727                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   471   511   541   549   586   624   624   632   642                 |
 |      646   646   646   664   664   673   681   706                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                 ISOBUTYRALDEHYDE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.0  98.0  98.0  98.0  96.0  90.0  88.0  78.0  70.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  93.9  85.7  71.4  49.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  92.0  78.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2000 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  70.0  64.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      500 PPM      1000 PPM     2000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       54.0%        49.0%        48.0%        64.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.265N     P=0.954      P=1.000      P=0.367N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       571.2        637.3        654.3        608.2    |
 |NATURAL DEATHS (C)      |       (31.1)       (12.7)       (13.5)       (17.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       659.1        672.4        692.6        688.7    |
 |(STANDARD ERROR)        |       (18.3)       (15.4)       ( 9.0)       (10.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                          ISOBUTYRALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        1000 PPM         = 3
                                                        2000 PPM         = 4

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

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

      |
  100 + 1                             2          1                        3  4
      |                               2          1                   2    31 34
      |                                                              2  2  1134   3
      |                                                                 2   1     1           2
   92 +                                                                           1 1         2 2
      |                                                                           4 134    1    2  2
      |                                                                                    1   1
      |                                                                              3 3
   84 +                                                                               43   3   11  2  2
      |                                                                                    4  4 11    22
      |                                                                                    3 344 11    22
      |                                                                                        4  11
P  76 +                                                                                      33         22
E     |                                                                                       33   1    1
R     |                                                                                        3  3
C     |                                                                                           334
E  68 +                                                                                             4 4 112
N     |                                                                                               4 411 2
T     |                                                                                            33   441 1
      |                                                                                             3 3  4 411
S  60 +                                                                                               33   4411  2
U     |                                                                                                33     1  1
R     |                                                                                                 33       22
V     |                                                                                                  33
I  52 +                                                                                                   33     121
V     |                                                                                                    334
A     |
L     |                                                                                                     343    11
   44 +                                                                                                       3  3 2 2
      |                                                                                                       44 33 11
      |                                                                                                           33
      |                                                                                                            33112
   36 +                                                                                                        4 4  33 2 2
      |                                                                                                              311
      |                                                                                                          4 4  33 22
      |                                                                                                                   2 2
   28 +                                                                                                            44  1 1
      |                                                                                                                  1  1
      |                                                                                                             4    4  1
      |                                                                                                                  34 3
   20 +                                                                                                                   4 4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 24 obs hidden.
                                                          ISOBUTYRALDEHYDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        500 PPM          = 2
                                                        1000 PPM         = 3
                                                        2000 PPM         = 4

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

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

      |
      |
  100 + 1        1                                                           4       3  2
      |          1                                                      1    4     4    2  2
      |                                                                 1   1 1    4 3  3  2  22   3
      |                                                                                       44   3    3
P  90 +                                                                       1       1        2   24   33
E     |                                                                               1        1   24 2  3 43
R     |                                                                                        1 1    2 2  43  3
C     |                                                                                          1 1    2  224 3 3
E  80 +                                                                                                      44
N     |                                                                                            1     1  22   3 3
T     |                                                                                                  11   4  4 33
      |                                                                                                   11 2   2 233
S  70 +                                                                                                    1     4 1
U     |                                                                                                            22
R     |                                                                                                            12134    4
V     |                                                                                                               33
I  60 +                                                                                                              112
V     |                                                                                                               1  1
A     |                                                                                                                  11 1
L     |                                                                                                                3 3
   50 +                                                                                                                2233 2
      |                                                                                                                   3 3
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 26 obs hidden.