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TDMS Study 05092-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/12/94   
EXP: 05092                     O-NITROANISOLE                  TIME: 19:33:08   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60388B   
CONT: N01-ES-45038                                             CAS: 0091-23-6   
PATHOLOGIST: J. HEATH                        S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/12/94  
EXP: 05092                     O-NITROANISOLE                  TIME: 19:33:08  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60388B  
CONT: N01-ES-45038                                             CAS: 0091-23-6  
PATHOLOGIST: J. HEATH                        S. EUSTIS                         

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      479   647   652   703   708   709   709   709   709   710                 |
 |      711   711   715   722   722                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0%     15 SSAC                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   456   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0666%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      549   582   709   709   710   710   710                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0666% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   456   456   456   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.200%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      617   626   672   707   708   708   708   709   709   711                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.200%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 9      UNCENSORED DEATHS 0      CENSORED DEATHS 9    TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.600%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    466   576   627   673   708   708   709   710   711                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.600%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   456   456   456   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  94.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  86.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0  98.0  98.0  98.0  98.0  96.0  96.0  94.0  92.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0.0%        0.0%        0.0666%     0.0666%     0.200%      0.200%      0.600%      0.600%   |
 |                                            15 SSAC                 15 SSAC                 15 SSAC                 15 SSAC  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%        0.0%       86.0%        0.0%       78.0%        0.0%       80.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.836N     -----      P=0.095N     -----      P=0.543N     -----      P=0.435N     -----   |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       687.7          .        668.4          .        690.6          .        598.6          .     |
 |NATURAL DEATHS (C)      |       (16.0)      (  . )      (26.8)      (  . )      (11.0)      (  . )      (61.1)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       715.9       456.1       719.7       455.9       719.8       456.1       702.1       455.9    |
 |(STANDARD ERROR)        |       ( 5.4)      ( 0.3)      ( 4.6)      ( 0.3)      ( 3.2)      ( 0.3)      (13.9)      ( 0.3)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


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

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      137   312   525   564   627   630   648   693   705   708                 |
 |      722   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0%    15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   456   456   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0666%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      331   353   392   425   619   646   648   674   676   679                 |
 |      682   691   695   700   700   704   708   710   710   710                 |
 |      711   711   711   714                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.0666% 15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   456   456   456   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.200%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      445   539   539   539   546   564   592   603   664   686                 |
 |      700   702   704   708   711   721   722                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.200%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   456   456   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.600%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      401   452   597   710   710                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.600%  15 SSAC                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   456   456   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0%       |   100.0  98.0  98.0  96.0  96.0  96.0  94.0  92.0  86.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0%       |   100.0 100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0  96.0  92.0  92.0  92.0  92.0  86.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0666%    |   100.0 100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  84.0  82.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.200%     |   100.0 100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  94.0  94.0  90.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.600%     |   100.0 100.0 100.0 100.0 100.0 100.0   0.0   0.0   0.0   0.0      |
 |15 SSAC    |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  O-NITROANISOLE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                        DOSE                                                 |
 |                                                                                                                             |
 |                                0.0%        0.0%        0.0666%     0.0666%     0.200%      0.200%      0.600%      0.600%   |
 |                                            15 SSAC                 15 SSAC                 15 SSAC                 15 SSAC  |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       76.0%        0.0%       52.0%        0.0%       66.0%        0.0%       90.0%        0.0%    |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.005N     -----      P=0.028     P=1.000N    P=0.369     P=1.000N    P=0.109N    P=1.000N |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       582.8          .        637.5          .        628.5          .        574.0          .     |
 |NATURAL DEATHS (C)      |       (52.6)      (  . )      (25.1)      (  . )      (21.2)      (  . )      (64.2)      (  . )   |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       693.1       456.0       684.6       455.9       694.2       456.0       712.6       456.0    |
 |(STANDARD ERROR)        |       (15.1)      ( 0.3)      (13.6)      ( 0.3)      ( 9.7)      ( 0.3)      ( 8.8)      ( 0.3)   |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


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

                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.0%     15 SSAC = 2
                                                        0.0666%          = 3
                                                        0.0666% 15 SSAC  = 4
                                                        0.200%           = 5
                                                        0.200%  15 SSAC  = 6
                                                        0.600%           = 7
                                                        0.600%  15 SSAC  = 8

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1              7                                                          2 1          3    3     55  1
      |                                                                           7                73      5  11  5    13
P     |                                                                                                    7       7   11
E     |                                                                                                                 3 3
R  80 +                                                                                                                 5 5
C     |                                                                                                                 111
E     |                                                                                                                   1
N     |
T  60 +
      |
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: 31 obs hidden.

                                                           O-NITROANISOLE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0%             = 1
                                                        0.0%    15 SSAC  = 2
                                                        0.0666%          = 3
                                                        0.0666% 15 SSAC  = 4
                                                        0.200%           = 5
                                                        0.200%  15 SSAC  = 6
                                                        0.600%           = 7
                                                        0.600%  15 SSAC  = 8

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1                     1                           1  3  3       7     5 7          2 5
      |                                                   1     3     3    3    7          1     1     7                7
P     |                                                                    3                 55  1    5   31  1         7 7
E     |                                                                                               5 5     1  5 3 1 1
R  80 +                                                                                                          5 333511 1
C     |                                                                                                              3355 1
E     |                                                                                                               33355
N     |                                                                                                                   5
T  60 +
      |
S     |                                                                                                                 3 3
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: 38 obs hidden.