National Toxicology Program

National Toxicology Program
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TR 371 Mouse Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: IRDC                                                      DATE: 09/18/94   
EXP: 05701                         TOLUENE                     TIME: 15:06:18   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 07272B   
CONT: 0570101                                                  CAS: 108883      
PATHOLOGIST: J. SAGARTZ                                                         
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REASONS FOR REMOVAL:                                                            
                                                                                
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INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: IRDC                                                      DATE: 09/18/94  
EXP: 05701                         TOLUENE                     TIME: 15:06:18  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 07272B  
CONT: 0570101                                                  CAS: 108883     
PATHOLOGIST: J. SAGARTZ                                                        

                                      TOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 42     CENSORED DEATHS 1    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      291   291   291   331   372   388   429   434   436   438                 |
 |      442   443   443   446   470   491   520   526   528   534                 |
 |      543   549   549   557   563   576   579   590   604   608                 |
 |      613   618   629   629   633   633   639   640   669   701                 |
 |      713   713                                                                 |
 |  CENSORED DEATHS                                                               |
 |      712                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 120 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 38     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      155   388   393   400   416   435   443   454   498   501                 |
 |      501   509   525   526   531   556   556   562   564   571                 |
 |      577   583   590   593   607   611   611   619   633   633                 |
 |      633   639   639   640   660   687   716   724                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 42     CENSORED DEATHS 2    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      229   277   278   306   319   323   331   374   379   390                 |
 |      405   418   425   430   430   443   448   450   452   470                 |
 |      473   485   508   518   551   555   563   563   563   569                 |
 |      576   577   619   632   639   639   639   674   689   716                 |
 |      724   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      500   554                                                                 |
 |                                                                                |
 ==================================================================================

                                      TOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1200 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 39     CENSORED DEATHS 2    TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      34    156   291   297   335   362   362   366   423   425                 |
 |      428   443   462   463   467   510   524   524   528   530                 |
 |      547   547   570   571   572   587   633   638   639   639                 |
 |      660   680   691   694   702   703   716   720   721                       |
 |  CENSORED DEATHS                                                               |
 |      565   565                                                                 |
 |                                                                                |
 ==================================================================================

                                      TOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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 PPM      |   100.0 100.0 100.0  93.3  90.0  75.0  65.0  51.7  36.7  29.8      |
 |           |                                                                    |
 |           |                                                                    |
 |120 PPM    |   100.0  98.3  98.3  98.3  91.7  86.7  75.0  60.0  41.7  36.7      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0 100.0  98.3  88.3  78.3  63.3  59.9  45.9  37.0  28.2      |
 |           |                                                                    |
 |           |                                                                    |
 |1200 PPM   |    98.3  96.7  96.7  88.3  83.3  75.0  66.7  56.3  47.5  33.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        120 PPM      600 PPM      1200 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       29.8%        36.7%        28.2%        33.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000      P=0.358N     P=0.744      P=0.662N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       526.0        549.4        494.6        516.9    |
 |NATURAL DEATHS (C)      |       (17.8)       (17.8)       (20.5)       (25.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       586.6        615.3        558.2        585.7    |
 |(STANDARD ERROR)        |       (17.3)       (15.9)       (19.6)       (21.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                      TOLUENE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 11   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      4     375   393   463   556   624   631   634   636   653                 |
 |      681   683   693   709   710   714   716   716   722                       |
 |  CENSORED DEATHS                                                               |
 |      347   457   457   457   457   457   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 120 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 13   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     430   452   458   477   534   599   646   653   683                 |
 |      686   687   690   722                                                     |
 |  CENSORED DEATHS                                                               |
 |      388   388   388   457   457   457   457   457   457   457                 |
 |      457   457   457                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 600 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 26     CENSORED DEATHS 10   TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      163   398   505   509   518   562   578   598   601   605                 |
 |      627   629   641   650   653   659   660   669   699   702                 |
 |      708   708   709   712   713   725                                         |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                      TOLUENE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1200 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 14   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      3     82    400   520   523   589   594   598   621   670                 |
 |      696   709   715   716                                                     |
 |  CENSORED DEATHS                                                               |
 |      229   457   457   457   457   457   457   457   457   457                 |
 |      457   488   488   488                                                     |
 |                                                                                |
 ==================================================================================

                                      TOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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 PPM      |    98.3  98.3  98.3  98.3  94.9  92.9  92.9  90.8  80.5  61.9      |
 |           |                                                                    |
 |           |                                                                    |
 |120 PPM    |    98.3  98.3  98.3  98.3  98.3  90.5  88.4  86.2  81.9  71.1      |
 |           |                                                                    |
 |           |                                                                    |
 |600 PPM    |   100.0  98.3  98.3  98.3  96.7  96.7  90.6  80.6  66.5  48.3      |
 |           |                                                                    |
 |           |                                                                    |
 |1200 PPM   |    96.7  96.7  96.7  96.7  95.0  95.0  90.6  83.9  81.7  70.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        120 PPM      600 PPM      1200 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.9%        71.1%        48.3%        70.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.991N     P=0.525N     P=0.209      P=0.572N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       595.4        551.8        611.6        531.1    |
 |NATURAL DEATHS (C)      |       (41.1)       (50.2)       (23.9)       (60.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       635.0        625.3        632.8        617.1    |
 |(STANDARD ERROR)        |       (19.0)       (19.5)       (16.1)       (21.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                              TOLUENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        120 PPM          = 2
                                                        600 PPM          = 3
                                                        1200 PPM         = 4

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

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

      |
      |
  100 + 1     4                  2          3         1
      |       4                  2          3       3 4               22
      |                                             3 143    1         22
      |                                                43  331   4 1  1 2 2  2
   90 +                                                     33        1     122
      |                                                      3   443 3     4112 2      2
      |                                                              33
      |                                                               3 3 34411        22
P  80 +                                                                   33  4  4      2  2
E     |                                                                    33 1  441       22
R     |                                                                     3 3   41  1 4   2   2
C     |                                                                       3 3     1 4  11   22
E  70 +                                                                                    44
N     |                                                                         3  3        1114 222
T     |                                                                            3 3        11   22
      |                                                                              3  33     11 4 2 2
S  60 +                                                                                  3     311    2 2
U     |                                                                                        331414   22  4
R     |                                                                                            1  1  22 44
V     |                                                                                               1 1 2 2
I  50 +                                                                                          333    11   4   4
V     |                                                                                                  11122   4  4
A     |                                                                                            3      3 3       444
L     |                                                                                                    112   2   244
   40 +                                                                                                     11       2   2
      |                                                                                                      1    13   4 22 2
      |                                                                                                           13 3 1
      |                                                                                                              3 1133 4
   30 +                                                                                                                 1   1
      |                                                                                                                   3 3
      |
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 40 obs hidden.

                                                              TOLUENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        120 PPM          = 2
                                                        600 PPM          = 3
                                                        1200 PPM         = 4

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

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

      |
      |
  100 + 112                       3
      |  12          4            3                                1   14   2   2       3
      |                                                                14       221        4
      |                                                                          21 2   33      1
P  90 +                                                                             2    3 4 2  13    4    11
E     |                                                                                      2   3 3   2
R     |                                                                                               42  4   22
C     |                                                                                                33 4 1  1  4 2
E  80 +                                                                                                 3  3   1  4 1 4
N     |                                                                                                    3 3      114 4
T     |                                                                                                      33      1  14
      |                                                                                                       33     2    2
S  70 +                                                                                                        3 3       42 2
U     |                                                                                                          33     11
R     |                                                                                                           3   3  11
V     |                                                                                                               33  1 1
I  60 +                                                                                                                33
V     |
A     |
L     |
   50 +                                                                                                                 3 3
      |                                                                                                                   3 3
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 21 obs hidden.

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