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TDMS Study 05107-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: LITRI                                                  NICKEL SUBSULFIDE                                  DATE: 05/19/95       
EXPERIMENT: 05107 TEST: 05                                                                                     TIME: 22:26:16       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: Y01ES30108                                ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C61654       
PATHOLOGIST: F. HAHN                                                                                           CAS: 12035722        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: LITRI                                                  NICKEL SUBSULFIDE                                  DATE: 05/19/95      
EXPERIMENT: 05107 TEST: 05                                                                                     TIME: 22:26:16      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: Y01ES30108                                ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C61654      
PATHOLOGIST: F. HAHN                                                                                           CAS: 12035722       

                                 NICKEL SUBSULFIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0MG/M3                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 40     CENSORED DEATHS 7    TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      257   361   373   521   537   539   542   553   559   559                 |
 |      565   565   572   573   574   578   594   596   599   608                 |
 |      615   624   634   635   639   651   657   664   671   678                 |
 |      683   691   696   699   701   705   706   713   715   728                 |
 |  CENSORED DEATHS                                                               |
 |      199   199   458   458   458   458   458                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0MG/M3LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      199   199   199   199   199   199   199   199   199   199                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.15    MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 32     CENSORED DEATHS 7    TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      398   455   538   549   552   563   569   570   594   594                 |
 |      595   599   599   601   608   623   623   624   638   638                 |
 |      639   639   642   650   661   690   695   700   713   717                 |
 |      718   727                                                                 |
 |  CENSORED DEATHS                                                               |
 |      199   199   458   458   458   458   458                                   |
 |                                                                                |
 ==================================================================================

                                 NICKEL SUBSULFIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.15    LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      199   199   199   199   199   199   199   199   199   199                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 35     CENSORED DEATHS 7    TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      408   424   509   527   552   559   560   564   564   577                 |
 |      578   584   590   594   595   621   621   623   629   642                 |
 |      643   648   650   663   663   678   703   703   703   707                 |
 |      711   716   723   726   731                                               |
 |  CENSORED DEATHS                                                               |
 |      199   199   458   458   458   458   458                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      199   199   199   199   199   199   199   199   199   199                 |
 |                                                                                |
 ==================================================================================

                                 NICKEL SUBSULFIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0MG/M3   |   100.0 100.0  98.3  96.6  94.8  94.8  87.2  64.5  47.4  24.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0MG/M3LUN|   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |TOX        |                                                                    |
 |           |                                                                    |
 |0.15       |   100.0 100.0 100.0 100.0  98.3  96.6  94.7  73.8  53.0  39.8      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |0.15       |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0 100.0 100.0  96.6  96.6  92.8  71.9  53.0  34.1      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                 NICKEL SUBSULFIDE


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


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                          DOSE                                               |
 |                                                                                                                             |
 |                                0.0MG/M3        0.0MG/M3LUNG    0.15            0.15            1.0             1.0          |
 |                                                TOX             MG/M3           LUNG TOX        MG/M3           LUNG TOX     |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       24.7%            0.0%           39.8%            0.0%           34.1%            0.0%        |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.579N         -----          P=0.123N         -----          P=0.260N         -----       |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       603.3              .            616.3              .            619.7              .         |
 |NATURAL DEATHS (C)      |       (15.8)          (  . )          (12.9)          (  . )          (13.6)          (  . )       |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       605.8           199.0           630.0           199.0           626.2           199.0        |
 |(STANDARD ERROR)        |       (17.1)          ( 0.0)          (16.1)          ( 0.0)          (16.2)          ( 0.0)       |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                 NICKEL SUBSULFIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0MG/M3                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 7    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      263   369   377   477   477   500   513   538   563   574                 |
 |      574   613   640   640   640   642   657   664   665   665                 |
 |      667   677   678   696   716   717   721   721                             |
 |  CENSORED DEATHS                                                               |
 |      200   200   459   459   459   459   459                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.0MG/M3LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      200   200   200   200   200   200   200   200   200   200                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0.15    MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 7    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      452   482   482   538   566   590   594   594   609   609                 |
 |      612   620   620   622   635   636   640   642   649   653                 |
 |      678   681   695   699   706   718   721   727                             |
 |  CENSORED DEATHS                                                               |
 |      200   200   459   459   459   459   459                                   |
 |                                                                                |
 ==================================================================================

                                 NICKEL SUBSULFIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0.15    LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      200   200   200   200   200   200   200   200   200   200                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     MG/M3                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 8    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   501   526   538   563   582   590   594   602   615                 |
 |      622   633   634   634   635   641   641   643   663   673                 |
 |      706   709   712   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      200   200   281   459   459   459   459   459                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1.0     LUNG TOX                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 10     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      200   200   200   200   200   200   200   200   200   200                 |
 |                                                                                |
 ==================================================================================

                                 NICKEL SUBSULFIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0.0MG/M3   |   100.0 100.0  98.3  98.3  94.8  91.0  85.3  79.7  62.6  47.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0MG/M3LUN|   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |TOX        |                                                                    |
 |           |                                                                    |
 |0.15       |   100.0 100.0 100.0 100.0 100.0  94.5  92.6  85.0  62.4  47.2      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |0.15       |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0 100.0 100.0 100.0  98.2  92.5  82.8  63.6  53.9      |
 |MG/M3      |                                                                    |
 |           |                                                                    |
 |1.0        |   100.0 100.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0   0.0      |
 |LUNG TOX   |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                 NICKEL SUBSULFIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                          DOSE                                               |
 |                                                                                                                             |
 |                                0.0MG/M3        0.0MG/M3LUNG    0.15            0.15            1.0             1.0          |
 |                                                TOX             MG/M3           LUNG TOX        MG/M3           LUNG TOX     |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       47.4%            0.0%           47.2%            0.0%           53.9%            0.0%        |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.563N         -----          P=1.000N         -----          P=0.633N         -----       |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       594.4              .            623.9              .            617.8              .         |
 |NATURAL DEATHS (C)      |       (22.3)          (  . )          (13.6)          (  . )          (14.1)          (  . )       |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       626.1           200.0           639.8           200.0           636.9           200.0        |
 |(STANDARD ERROR)        |       (18.2)          ( 0.0)          (15.9)          ( 0.0)          (17.0)          ( 0.0)       |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                                         NICKEL SUBSULFIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0MG/M3         = 1
                                                        0.0MG/M3LUNG TOX = 2
                                                        0.15    MG/M3    = 3
                                                        0.15    LUNG TOX = 4
                                                        1.0     MG/M3    = 5
                                                        1.0     LUNG TOX = 6

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

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

  100 + 1                                        1                     3 5
      |                                          1               1 1   3 5 5    3       5    3
      |                                                            1                    5  153 3
      |                                                                                    151 5
   90 +                                                                                      113533
      |                                                                                       1155
      |                                                                                        11 3   3
      |                                                                                         11 5
   80 +                                                                                            55 33
      |                                                                                          11 5 5
      |                                                                                                33
      |                                                                                           11  5 3 3
P  70 +                                                                                            1  1
E     |                                                                                               11  33 3
R     |                                                                                                11  5 5
C     |                                                                                                 11
E  60 +                                                                                                  1 1155
N     |                                                                                                      33  5
T     |                                                                                                     113  3
      |                                                                                                      11  3 5 3
S  50 +                                                                                                       11 1 5 335
U     |                                                                                                          11   3 3
R     |                                                                                                           11    33
V     |                                                                                                            111 5533
I  40 +                                                                                                              11  53 3
V     |
A     |                                                                                                               11  5 5
L     |
   30 +                                                                                                                11
      |                                                                                                                 111
      |                                                                                                                   1 1
      |
   20 +
      |
      |
      |
   10 +
      |
      |
      |
    0 +                                          2
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 30 obs hidden.

                                                         NICKEL SUBSULFIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0.0MG/M3         = 1
                                                        0.0MG/M3LUNG TOX = 2
                                                        0.15    MG/M3    = 3
                                                        0.15    LUNG TOX = 4
                                                        1.0     MG/M3    = 5
                                                        1.0     LUNG TOX = 6

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

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

  100 + 1                                         1                           5 3
      |                                           1               11          5 3   3  5    5
      |                                                            1                1       53
      |                                                                                      3   3
   90 +                                                                             1  1 1       3  5 3
      |                                                                                  1   1      5 5
      |                                                                                      1   1    353
      |                                                                                          11    533
   80 +                                                                                           1      13 5
      |                                                                                                  1   1
      |
      |                                                                                                   3 35
P  70 +                                                                                                     31 1
E     |                                                                                                        1 1
R     |                                                                                                      333 5
C     |                                                                                                        3 113   5
E  60 +                                                                                                           113  55
N     |                                                                                                            13 1
T     |                                                                                                               13515 5
      |                                                                                                                3 3
S  50 +                                                                                                                  33
U     |                                                                                                                  13 1
R     |
V     |
I  40 +
V     |
A     |
L     |
   30 +
      |
      |
      |
   20 +
      |
      |
      |
   10 +
      |
      |
      |
    0 +                                           2
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 36 obs hidden.