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TDMS Study 05114-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Northwest                                        DATE: 09/14/94   
EXP: 05114            HEXACHLOROCYCLOPENTADIENE (HCCPD)        TIME: 13:49:13   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 00125    
CONT: NO1ES2800301                                             CAS: 77-47-4     
PATHOLOGIST: R. RENNE                        HAILEY, JAMES R.                   
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Northwest                                        DATE: 09/14/94  
EXP: 05114            HEXACHLOROCYCLOPENTADIENE (HCCPD)        TIME: 13:49:13  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 00125   
CONT: NO1ES2800301                                             CAS: 77-47-4    
PATHOLOGIST: R. RENNE                        HAILEY, JAMES R.                  

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      373   464   481   536   544   548   565   569   591   597                 |
 |      597   600   617   624   625   626   628   633   635   651                 |
 |      660   661   681   683   691   694   698   712   712   719                 |
 |      724   729                                                                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.01 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 34     CENSORED DEATHS 10   TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      355   370   379   451   523   540   541   544   564   565                 |
 |      584   597   600   600   615   628   634   635   636   639                 |
 |      639   649   662   670   681   695   698   704   705   709                 |
 |      719   724   724   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      233   365   402   471   506   506   516   535   541   547                 |
 |      565   597   611   635   649   664   666   680   701   704                 |
 |      705   705   709   710   712   712   723   724                             |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.2                                      |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 34     CENSORED DEATHS 10   TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      180   220   460   474   485   500   534   541   542   582                 |
 |      585   589   600   600   612   617   620   621   628   628                 |
 |      639   639   653   668   681   683   695   704   704   709                 |
 |      712   719   723   724                                                     |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  94.3  90.3  76.3  56.2  36.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.01 PPM   |   100.0 100.0 100.0  98.3  95.0  93.3  85.2  73.0  54.8  32.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.05 PPM   |   100.0 100.0  98.3  96.7  95.0  93.0  82.9  76.8  68.7  44.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.2        |   100.0  98.3  96.7  96.7  96.7  90.6  82.6  72.5  54.4  32.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.01 PPM     0.05 PPM     0.2      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       36.1%        32.5%        44.5%        32.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.649      P=0.775      P=0.513N     P=0.679  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.9        609.0        599.8        596.2    |
 |NATURAL DEATHS (C)      |       (14.5)       (17.4)       (23.7)       (21.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.5        616.1        623.9        608.9    |
 |(STANDARD ERROR)        |       (13.9)       (15.0)       (16.5)       (16.7)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      376   376   488   502   625   639   639   640   653   660                 |
 |      663   677   680   681   681   683   686   703   705   709                 |
 |      719   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.01 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      521   565   621   625   638   654   654   659   668   681                 |
 |      683   691   694   705   709   724   724                                   |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      366   367   402   549   550   561   562   569   585   590                 |
 |      597   611   618   642   652   695   695   709   718                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.2                                      |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      528   541   569   588   597   617   625   626   628   635                 |
 |      658   667   667   668   696   710   710   724   726   726                 |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                         HEXACHLOROCYCLOPENTADIENE (HCCPD)


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  96.7  96.7  92.6  92.6  78.5  56.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.01 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  84.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.05 PPM   |   100.0 100.0 100.0 100.0  94.9  94.9  94.9  78.4  70.2  61.9      |
 |           |                                                                    |
 |           |                                                                    |
 |0.2        |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  78.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.01 PPM     0.05 PPM     0.2      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.4%        66.0%        61.9%        60.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000      P=0.361N     P=0.958N     P=0.843N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       632.3        659.8        580.9        645.3    |
 |NATURAL DEATHS (C)      |       (21.7)       (13.2)       (24.2)       (13.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       649.0        664.9        636.1        656.6    |
 |(STANDARD ERROR)        |       (14.7)       (13.1)       (15.6)       (13.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                 HEXACHLOROCYCLOPENTADIENE (HCCPD)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.01 PPM         = 2
                                                        0.05 PPM         = 3
                                                        0.2              = 4

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

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

      |
      |
  100 + 1                            4       3                  2  1
      |                              4     4 3                  2 21 2  3        41 1
      |                                                              2  3       24 31        1
      |                                                                         2  3 4  3  2 11
   90 +                                                                              4 433    11
      |                                                                                4 3   341 11
P     |                                                                                      32  21   1
E     |                                                                                       33    4 11
R  80 +                                                                                        3 2  2  2
C     |                                                                                             4 41 31
E     |                                                                                                  3113
N     |                                                                                                2 2  3 3
T  70 +                                                                                                  2422 3  3
      |                                                                                                          33 3
S     |                                                                                                   411       3  3
U     |                                                                                                     121
R  60 +                                                                                                    4 21  1
V     |                                                                                                      424 2     33
I     |                                                                                                        4 12 1
V     |                                                                                                           2 11
A  50 +                                                                                                             211
L     |                                                                                                             4 223 3
      |                                                                                                               1 1 3 3
      |                                                                                                                211
   40 +                                                                                                                 211
      |                                                                                                                 421 1
      |                                                                                                                     1
      |                                                                                                                   2 2
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 52 obs hidden.

                                                 HEXACHLOROCYCLOPENTADIENE (HCCPD)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.01 PPM         = 2
                                                        0.05 PPM         = 3
                                                        0.2              = 4

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

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

      |
      |
  100 + 1                                                         31                       24
      |
      |                                                                                    24 4  2
      |                                                           31    3            1        4  24       2
   95 +                                                                 3            1 1       3
      |                                                                                           4 4     22
      |                                                                                1            4  4   1 2
      |                                                                                        3 3         1 1
   90 +                                                                                                4  4  2 2
      |
P     |                                                                                                   44
E     |                                                                                          33            2 2
R  85 +                                                                                           3 3        1 1
C     |                                                                                                          22
E     |                                                                                             3 3    44  1 12 2
N     |
T  80 +                                                                                               33    4  4
      |                                                                                                3 3       1 1
S     |                                                                                                        4  4 22
U     |                                                                                                  33        1122
R  75 +
V     |                                                                                                   3  3        22
I     |                                                                                                      3 3  4   422
V     |
A  70 +                                                                                                        3      3 2 2
L     |
      |
      |                                                                                                             1 313 2 2
   65 +
      |                                                                                                                 33
      |                                                                                                                113  3
      |
   60 +                                                                                                                 114 4
      |                                                                                                                  11
      |
      |                                                                                                                   1 1
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.