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TDMS Study 88034-03 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Northwest                                        DATE: 05/08/95   
EXP: 88034                          OZONE                      TIME: 20:11:15   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: C88034   
CONT: N01-ES-95239                                             CAS: 10028-15-6  
PATHOLOGIST: S. GRUMBEIN                                                        
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Northwest                                        DATE: 05/08/95  
EXP: 88034                          OZONE                      TIME: 20:11:15  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: C88034  
CONT: N01-ES-95239                                             CAS: 10028-15-6 
PATHOLOGIST: S. GRUMBEIN                                                       

                                       OZONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 41     CENSORED DEATHS 7    TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      247   359   462   481   498   514   516   517   537   543                 |
 |      546   562   565   575   578   583   594   600   601   606                 |
 |      624   632   639   639   643   644   648   648   651   670                 |
 |      670   674   676   681   681   687   695   697   709   715                 |
 |      720                                                                       |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602   617                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.12 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 45     CENSORED DEATHS 6    TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      175   441   441   466   468   480   489   503   533   537                 |
 |      540   574   591   603   603   605   608   611   616   619                 |
 |      622   625   639   639   642   653   653   663   667   667                 |
 |      676   678   681   681   691   693   695   695   698   701                 |
 |      709   709   716   723   723                                               |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 43     CENSORED DEATHS 6    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      264   387   433   442   454   470   498   499   520   524                 |
 |      527   539   546   575   583   583   592   604   608   611                 |
 |      621   625   625   625   639   649   654   663   669   671                 |
 |      678   681   681   687   695   697   698   701   715   720                 |
 |      722   723   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 43     CENSORED DEATHS 6    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   422   458   502   526   540   552   559   562   568                 |
 |      574   583   583   590   596   600   611   615   616   616                 |
 |      619   621   623   623   635   640   644   651   653   654                 |
 |      658   658   659   665   667   667   667   681   695   709                 |
 |      715   723   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       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  98.2  96.4  96.4  92.9  82.1  66.1  44.1  17.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.12 PPM   |   100.0  98.2  98.2  98.2  98.2  89.3  80.4  70.6  45.7  10.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0 100.0  98.2  98.2  96.4  89.3  78.6  67.5  46.4  14.8      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |   100.0 100.0 100.0 100.0  96.4  94.6  89.3  71.4  33.6  14.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.12 PPM     0.5 PPM      1.0 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       17.6%        10.4%        14.8%        14.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.936      P=0.876      P=1.000N     P=0.870  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       598.2        609.8        600.5        611.5    |
 |NATURAL DEATHS (C)      |       (15.2)       (15.6)       (15.9)       (11.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       618.2        620.0        617.2        625.7    |
 |(STANDARD ERROR)        |       (12.7)       (13.4)       (13.5)       (10.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                       OZONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 22     CENSORED DEATHS 6    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      362   443   446   502   527   537   553   566   571   603                 |
 |      608   630   665   667   681   687   688   695   709   709                 |
 |      709   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.12 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 26     CENSORED DEATHS 6    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      275   413   469   470   541   568   579   583   596   596                 |
 |      600   611   622   628   637   664   667   667   677   681                 |
 |      701   702   708   709   714   727                                         |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 20     CENSORED DEATHS 6    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      120   378   536   553   555   591   613   638   653   657                 |
 |      659   660   665   697   698   702   709   709   723   730                 |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.0 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 56     UNCENSORED DEATHS 23     CENSORED DEATHS 6    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      50    183   275   434   463   512   526   571   583   616                 |
 |      627   636   641   648   651   654   665   668   681   683                 |
 |      685   715   719                                                           |
 |  CENSORED DEATHS                                                               |
 |      602   602   602   602   602   602                                         |
 |                                                                                |
 ==================================================================================

                                       OZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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    |   100.0 100.0 100.0  98.2  98.2  94.6  89.3  81.9  75.7  57.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.12 PPM   |   100.0 100.0 100.0  98.2  96.4  92.9  91.1  80.4  70.1  49.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5 PPM    |   100.0  98.2  98.2  98.2  96.4  96.4  94.6  89.3  75.1  60.9      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0 PPM    |    98.2  98.2  96.4  94.6  94.6  91.1  87.5  83.9  67.6  55.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.12 PPM     0.5 PPM      1.0 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.3%        49.5%        60.9%        55.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.931N     P=0.535      P=0.729N     P=0.866  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       603.7        607.9        612.3        560.3    |
 |NATURAL DEATHS (C)      |       (21.8)       (20.8)       (32.0)       (36.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       668.2        660.9        675.9        648.0    |
 |(STANDARD ERROR)        |       (12.1)       (12.7)       (14.0)       (18.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                               OZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.12 PPM         = 2
                                                        0.5 PPM          = 3
                                                        1.0 PPM          = 4

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

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

      |
      |
  100 + 1                           2           1 3                4
      |                             2           1 3              1 4  3    432   1
      |                                                                     323  12 1  4
      |                                                                       3 3   1  1    4
   90 +                                                                         3 2322 1 1  4 44
      |                                                                              2 2       44
      |                                                                                2 1 3 11 444
      |                                                                                    3322
   80 +                                                                                     331  12 4
      |                                                                                      33  1214 2 2
P     |                                                                                            33 44
E     |                                                                                            11 14 4
R  70 +                                                                                               113
C     |                                                                                                 22
E     |                                                                                                11221
N     |                                                                                                  3311
T  60 +                                                                                                   2211
      |                                                                                                    2 2
S     |                                                                                                   4343
U     |                                                                                                     4232
R  50 +                                                                                                      113
V     |                                                                                                      442 23
I     |                                                                                                       14 21
V     |                                                                                                           22
A  40 +                                                                                                           113
L     |                                                                                                        4 4 22
      |                                                                                                            1133
      |                                                                                                          44 22
   30 +                                                                                                             112
      |                                                                                                           4 4113
      |                                                                                                             4 1313
      |                                                                                                               2211
   20 +                                                                                                                2233
      |                                                                                                                 21  1
      |                                                                                                                  22 3
      |
   10 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 60 obs hidden.

                                                               OZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.12 PPM         = 2
                                                        0.5 PPM          = 3
                                                        1.0 PPM          = 4

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

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

      |
  100 + 1        4          3                       2            1
      |          4          3         4             2            1 3     2    1
      |
      |                               4             4              3     2        2          3
   95 +                                             4                       4 1   22   1     3 3
      |
      |                                                                     4     42   1    1 233
      |                                                                           4      4  112 3 2   3
   90 +
      |                                                                                  4  41 1  22  3  3
      |                                                                                     4  1 1422    3   3
      |                                                                                          11 2  2
P  85 +                                                                                                      3 3
E     |                                                                                           1 4   14
R     |                                                                                                  4 4
C     |                                                                                                        3 3
E  80 +                                                                                                212 14
N     |                                                                                                  22
T     |                                                                                                    144   1
      |                                                                                                   22 44  11
S  75 +                                                                                                          3    3
U     |                                                                                                    22     1 1
R     |                                                                                                     2    2
V     |                                                                                                       44    1133
I  70 +                                                                                                        4 22
V     |                                                                                                                33
A     |                                                                                                          44  11
L     |                                                                                                           22
   65 +                                                                                                           4 4 1 1 3
      |                                                                                                            22
      |                                                                                                                   3 3
      |                                                                                                             2  2    3
   60 +
      |                                                                                                             4   141
      |                                                                                                                22 1 1
      |
   55 +                                                                                                                  4  4
      |
      |
      |                                                                                                                 2 2
   50 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.