National Toxicology Program

National Toxicology Program
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TDMS Study 05136-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                       CHLOROPRENE                                      DATE: 09/13/96       
EXPERIMENT: 05136 TEST: 07                                                                                     TIME: 16:35:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05291                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 50522B       
PATHOLOGIST: S. GRUMBEIN                                                                                       CAS: 0000126-99-8    
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Northwest                                       CHLOROPRENE                                      DATE: 09/13/96      
EXPERIMENT: 05136 TEST: 07                                                                                     TIME: 16:35:26      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-05291                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 50522B      
PATHOLOGIST: S. GRUMBEIN                                                                                       CAS: 0000126-99-8   
                                    CHLOROPRENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      469   489   525   533   534   536   541   569   569   571                 |
 |      575   576   580   589   600   604   613   613   616   616                 |
 |      634   634   637   637   642   646   649   657   658   693                 |
 |      695   695   695   702   716   716   722                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12.8 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 41     CENSORED DEATHS 0    TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      357   437   497   525   530   534   541   541   544   556                 |
 |      575   581   581   597   600   603   608   609   613   618                 |
 |      637   638   645   650   651   663   665   665   665   670                 |
 |      677   679   689   700   700   701   701   702   706   707                 |
 |      730                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 32 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 45     CENSORED DEATHS 0    TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      460   460   497   497   505   506   512   523   524   528                 |
 |      534   534   540   549   561   565   567   568   569   569                 |
 |      569   584   585   590   595   609   609   620   622   622                 |
 |      622   637   642   652   665   667   679   681   681   702                 |
 |      705   707   721   721   725                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLOROPRENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 80 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 46     CENSORED DEATHS 0    TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      305   307   463   470   497   522   530   532   533   539                 |
 |      540   549   558   567   576   578   583   597   601   603                 |
 |      608   609   611   613   617   625   625   625   628   646                 |
 |      649   651   651   660   660   663   663   667   672   673                 |
 |      691   693   702   702   715   728                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLOROPRENE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  86.0  68.0  42.0  26.0      |
 |           |                                                                    |
 |           |                                                                    |
 |12.8 PPM   |   100.0 100.0 100.0  98.0  98.0  96.0  82.0  68.0  42.0  18.0      |
 |           |                                                                    |
 |           |                                                                    |
 |32 PPM     |   100.0 100.0 100.0 100.0 100.0  96.0  74.0  50.0  30.0  10.0      |
 |           |                                                                    |
 |           |                                                                    |
 |80 PPM     |   100.0 100.0 100.0  96.0  96.0  92.0  78.0  60.0  26.0   8.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      12.8 PPM     32 PPM       80 PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       26.0%        18.0%        10.0%         8.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.013      P=0.615      P=0.025      P=0.025  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       614.8        616.8        595.1        597.8    |
 |NATURAL DEATHS (C)      |       (10.8)       (12.5)       (11.0)       (13.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       645.5        637.7        608.9        608.6    |
 |(STANDARD ERROR)        |       (10.9)       (12.0)       (11.5)       (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)
                                    CHLOROPRENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      366   432   553   573   581   589   600   601   622   644                 |
 |      651   651   661   665   665   670   687   697   702   721                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 12.8 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      302   352   485   525   565   576   608   630   657   665                 |
 |      667   671   679   681   681   691   694   707   707   721                 |
 |      721   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 32 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      450   470   534   540   544   567   585   588   590   597                 |
 |      597   601   604   608   618   634   646   651   651   679                 |
 |      691   693   693   721                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLOROPRENE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 80 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      433   463   525   553   572   576   589   591   609   611                 |
 |      613   617   624   624   637   648   649   660   666   667                 |
 |      671   673   679   705   705   716   720   721   729                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLOROPRENE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  95.9  95.9  83.7  69.4  59.2      |
 |           |                                                                    |
 |           |                                                                    |
 |12.8 PPM   |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  88.0  80.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |32 PPM     |   100.0 100.0 100.0 100.0 100.0  96.0  90.0  74.0  62.0  52.0      |
 |           |                                                                    |
 |           |                                                                    |
 |80 PPM     |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  84.0  64.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      12.8 PPM     32 PPM       80 PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       59.2%        56.0%        52.0%        42.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.085      P=1.000      P=0.473      P=0.151  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       616.6        623.2        606.3        629.2    |
 |NATURAL DEATHS (C)      |       (19.7)       (24.7)       (13.9)       (13.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       685.5        684.7        672.2        672.8    |
 |(STANDARD ERROR)        |       (11.4)       (13.2)       (11.2)       (10.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

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

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

      |
  100 + 1                                               4       2                31
      |                                                         2            2    1  1
      |                                                 4                    2   344 12    1 1
      |                                                                            4  3 3  22
   90 +                                                                               4    422
      |                                                                                 33 4411
      |                                                                                  3 3441   1
      |                                                                                    33 2 2
   80 +                                                                                     334 2 11
      |                                                                                       44
      |                                                                                      33344 1  12
      |                                                                                        3 3 4  11
P  70 +                                                                                                11
E     |                                                                                            44   11
R     |                                                                                          33 4  422
C     |                                                                                                4422
E  60 +                                                                                                  12 1
N     |                                                                                           3 3       22
T     |                                                                                             3 3 44   22
      |                                                                                                  44 11
S  50 +                                                                                               3 3 44 11  2
U     |
R     |                                                                                                 3 3   11
V     |                                                                                                    4  41 22  1
I  40 +                                                                                                           22 11
V     |                                                                                                   3 3
A     |                                                                                                     3343 4 2 211
L     |                                                                                                        3 3     1 1
   30 +                                                                                                          33   22
      |                                                                                                           33     11
      |                                                                                                          4433     1 1
      |                                                                                                           443  3
   20 +                                                                                                            4 4 2    2
      |                                                                                                                     2
      |                                                                                                              4 3 3
      |                                                                                                                4 33
   10 +                                                                                                                  43 3
      |                                                                                                                   4 4
      |
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 28 obs hidden.
                                                            CHLOROPRENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        12.8 PPM         = 2
                                                        32 PPM           = 3
                                                        80 PPM           = 4

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

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

      |
      |
  100 + 1                                               2         1         4   3
      |                                                 2       2 1         1   3 43
      |                                                         2           1     43 2     2 331  1
      |                                                                                    2   4 211
P  90 +                                                                                       3  241  1
E     |                                                                                          3 23 112
R     |                                                                                             3 3 2  2   2
C     |                                                                                               31441  1 2 2
E  80 +                                                                                                      11  22
N     |                                                                                                  44
T     |                                                                                                33 44  1  1222
      |                                                                                                 3 344
S  70 +                                                                                                   3 3 4  11 22
U     |                                                                                                     3 3   1  12
R     |                                                                                                       4  44  112
V     |                                                                                                       3    3  11 2
I  60 +                                                                                                            3 3 1 1  1
V     |                                                                                                           44     22
A     |                                                                                                            4 3 4 32 2
L     |                                                                                                                  3  3
   50 +                                                                                                                4 4
      |
      |                                                                                                                  4  4
      |                                                                                                                     4
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 28 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.