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TDMS Study 05096-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Northwest                                        DATE: 09/13/94   
EXP: 05096            0-CHLOROBENZALMALONONITRILE (CS-2)       TIME: 02:14:39   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 55118    
CONT: N01-ES-38061                                             CAS: 2698-41-1   
PATHOLOGIST: R. MILLER                                                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Northwest                                        DATE: 09/13/94  
EXP: 05096            0-CHLOROBENZALMALONONITRILE (CS-2)       TIME: 02:14:39  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 55118   
CONT: N01-ES-38061                                             CAS: 2698-41-1  
PATHOLOGIST: R. MILLER                                                         

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   463   508   515   529   529   553   567   569   571                 |
 |      571   585   612   630   655   666   674   674   699   702                 |
 |      702   732   739   747                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .075 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      431   485   553   560   571   571   586   598   631   639                 |
 |      648   655   667   667   667   667   674   678   687   687                 |
 |      690   702   702   702   711   714   724   728   730   732                 |
 |      737   741   744                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      389   439   452   529   529   536   571   577   588   592                 |
 |      592   599   620   641   660   667   667   667   674   687                 |
 |      687   698   702   702   702   714   730   736   745                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.75 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      473   522   571   577   581   606   612   625   625   638                 |
 |      641   655   660   662   667   674   694   694   714   714                 |
 |      732   733   739   742                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   749 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  76.0  70.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.075 MG/M3 |   100.0 100.0 100.0 100.0 100.0  96.0  96.0  84.0  76.0  34.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25 MG/M3 |   100.0 100.0 100.0 100.0  98.0  94.0  88.0  76.0  70.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.75 MG/M3 |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  72.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      .075 MG/M3   0.25 MG/M3   0.75 MG/M|
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       52.0%        34.0%        42.0%        52.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.396N     P=0.247      P=0.509      P=0.909N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       609.6        656.9        623.9        648.0    |
 |NATURAL DEATHS (C)      |       (18.2)       (13.2)       (17.3)       (14.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       682.1        688.2        676.4        700.5    |
 |(STANDARD ERROR)        |       (13.2)       (10.7)       (13.3)       ( 9.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      465   487   507   543   561   563   567   576   583   588                 |
 |      589   601   606   616   641   641   652   666   667   667                 |
 |      668   679   681   694   702   714   714   718   724   745                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .075 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      438   445   466   508   519   527   568   571   571   584                 |
 |      601   602   602   612   666   687   690   694   702   714                 |
 |      715   717   720   729   730   737                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      370   457   465   536   546   549   563   571   591   606                 |
 |      617   631   639   658   680   690   691   709   732   739                 |
 |      744                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.75 MG/M3                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      476   505   522   536   578   584   599   606   624   633                 |
 |      633   634   639   641   648   660   660   662   667   694                 |
 |      702   716   719                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                        0-CHLOROBENZALMALONONITRILE (CS-2)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 749 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   749 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  76.0  66.0  40.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.075 MG/M3 |   100.0 100.0 100.0 100.0 100.0  94.0  88.0  74.0  72.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25 MG/M3 |   100.0 100.0 100.0 100.0  98.0  94.0  92.0  82.0  72.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.75 MG/M3 |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  86.0  64.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      .075 MG/M3   0.25 MG/M3   0.75 MG/M|
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       40.0%        48.0%        58.0%        54.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.327N     P=0.482N     P=0.128N     P=0.265N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       627.5        619.8        608.8        623.4    |
 |NATURAL DEATHS (C)      |       (13.5)       (18.7)       (21.8)       (13.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       676.1        681.8        690.1        691.2    |
 |(STANDARD ERROR)        |       (11.7)       (13.3)       (13.4)       (10.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                 0-CHLOROBENZALMALONONITRILE (CS-2)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        .075 MG/M3       = 2
                                                        0.25 MG/M3       = 3
                                                        0.75 MG/M3       = 4

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

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

      |
      |
  100 + 1                                                             3     21     4
      |                                                               3     21    14 2     4
      |                                                                      3  3 1  2  11 43  22 44
      |                                                                                  1  1   2 2
   90 +                                                                                     33     4    4
      |                                                                                     13 1  2 2   44
P     |                                                                                        1 1132  2 4 42
E     |                                                                                             3 3    422
R  80 +                                                                                                      22
C     |                                                                                           1 1 33     422
E     |                                                                                             1  3 131 3 2 42
N     |                                                                                                    1 3 1 34
T  70 +                                                                                                        1 314
      |                                                                                                           11  4
S     |                                                                                                           31 21 4
U     |                                                                                                            3 311
R  60 +                                                                                                                 4   4
V     |                                                                                                              231    1
I     |                                                                                                               33    111
V     |                                                                                                                22    41
A  50 +                                                                                                                33
L     |                                                                                                                 2 2 3
      |                                                                                                                   2 233
      |                                                                                                                       3
   40 +                                                                                                                     22
      |
      |                                                                                                                      22
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 38 obs hidden.

                                                 0-CHLOROBENZALMALONONITRILE (CS-2)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        .075 MG/M3       = 2
                                                        0.25 MG/M3       = 3
                                                        0.75 MG/M3       = 4

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

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

      |
      |
  104 +
      |
      | 1                                                         3          2    14
      |                                                           3          22  314 1  4
   96 +                                                                       2  32  1  1  4
      |                                                                           2     1  4 31
      |                                                                                 2  2 31  1 4
      |                                                                                    22 33   44
P  88 +                                                                                     2  3 32 4  4
E     |                                                                                          131   44
R     |                                                                                           311 3 4  4
C     |                                                                                           2 2 3 3  44
E  80 +                                                                                             1 123 3
N     |                                                                                               11  3 3
T     |                                                                                                11   33
      |                                                                                                211   3 3
S  72 +                                                                                                  1   143  2 3
U     |                                                                                                       4  42 32
R     |                                                                                                      1 1
V     |                                                                                                        1  1  22 3
I  64 +                                                                                                          44   223   3
V     |                                                                                                           4   422   33
A     |                                                                                                               4422   33
L     |                                                                                                           11   4 4    3
   56 +                                                                                                            11
      |                                                                                                             1 1  2  2 4
      |                                                                                                               11
      |                                                                                                                11   22
   48 +                                                                                                                      22
      |                                                                                                                 11
      |                                                                                                                  11
      |                                                                                                                   1   1
   40 +                                                                                                                       1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 20 obs hidden.

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