National Toxicology Program

National Toxicology Program
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TDMS Study 05110-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Northrop Services                                         DATE: 09/14/94   
EXP: 05110                       NAPHTHALENE                   TIME: 02:28:35   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 52904B   
CONT: NO1ES790009                                              CAS: 91-20-3     
PATHOLOGIST: L. BRENNECKE                                                       
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Northrop Services                                         DATE: 09/14/94  
EXP: 05110                       NAPHTHALENE                   TIME: 02:28:35  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: RESPIRATORY EXPOSURE WHOLE  NTP C#: 52904B  
CONT: NO1ES790009                                              CAS: 91-20-3    
PATHOLOGIST: L. BRENNECKE                                                      

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 44     CENSORED DEATHS 5    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      15    48    48    83    83    83    83    84    88    112                 |
 |      134   158   183   196   235   255   282   320   326   327                 |
 |      361   382   383   389   396   421   465   558   589   590                 |
 |      620   652   654   655   681   688   697   700   704   706                 |
 |      706   714   715   725                                                     |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 17     CENSORED DEATHS 6    TERMINAL 52        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      14    30    31    119   265   287   303   330   372   536                 |
 |      629   640   659   680   690   692   693                                   |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    147                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 5      CENSORED DEATHS 10   TERMINAL 60        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      280   302   504   578   644                                               |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    91    182   182   196   547                 |
 |                                                                                |
 ==================================================================================

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 30 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 10     CENSORED DEATHS 7    TERMINAL 58        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      14    493   611   616   631   656   672   696   700   702                 |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    91    91                                    |
 |                                                                                |
 ==================================================================================

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    87.1  82.9  77.1  70.0  62.9  61.4  61.4  57.1  51.4  37.1      |
 |           |                                                                    |
 |           |                                                                    |
 |10 PPM     |    95.8  94.4  92.9  88.6  87.1  87.1  85.7  85.7  81.3  75.5      |
 |           |                                                                    |
 |           |                                                                    |
 |30 PPM     |   100.0 100.0 100.0  97.0  97.0  97.0  95.5  93.9  92.4  92.4      |
 |           |                                                                    |
 |           |                                                                    |
 |30 PPM     |    98.7  98.7  98.7  98.7  98.7  98.7  97.2  97.2  91.3  85.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      10 PPM       30 PPM       30 PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       37.1%        75.5%        92.4%        85.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       393.0        410.0        461.6        579.1    |
 |NATURAL DEATHS (C)      |       (37.4)       (62.9)       (73.2)       (65.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       486.7        606.1        636.5        649.7    |
 |(STANDARD ERROR)        |       (32.2)       (28.7)       (25.8)       (25.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 10     CENSORED DEATHS 6    TERMINAL 59        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      140   140   183   574   590   644   655   662   678   729                 |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    561                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 10 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 7      CENSORED DEATHS 11   TERMINAL 57        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      183   197   287   548   669   716   718                                   |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    91    91    127   127   463                 |
 |      586                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 16     CENSORED DEATHS 7    TERMINAL 52        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      67    351   366   427   466   614   626   648   663   677                 |
 |      688   696   711   713   714   722                                         |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    91    234                                   |
 |                                                                                |
 ==================================================================================

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 30 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 17     CENSORED DEATHS 8    TERMINAL 50        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   471   611   623   625   627   648   658   659   660                 |
 |      668   689   696   702   708   721   731                                   |
 |  CENSORED DEATHS                                                               |
 |      14    14    14    14    14    91    156   215                             |
 |                                                                                |
 ==================================================================================

                                    NAPHTHALENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0  97.1  95.7  95.7  95.7  95.7  95.7  92.8  88.5  85.6      |
 |           |                                                                    |
 |           |                                                                    |
 |10 PPM     |   100.0 100.0  97.0  95.5  95.5  95.5  95.5  93.9  93.9  89.2      |
 |           |                                                                    |
 |           |                                                                    |
 |30 PPM     |    98.6  98.6  98.6  97.1  95.6  92.7  92.7  92.7  86.8  76.5      |
 |           |                                                                    |
 |           |                                                                    |
 |30 PPM     |   100.0 100.0 100.0 100.0  98.5  97.0  97.0  97.0  85.1  74.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      10 PPM       30 PPM       30 PPM   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       85.6%        89.2%        76.5%        74.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.042      P=0.697N     P=0.274      P=0.195  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       499.5        474.0        571.8        642.4    |
 |NATURAL DEATHS (C)      |       (76.6)       (92.3)       (46.5)       (19.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       654.0        624.3        637.5        643.4    |
 |(STANDARD ERROR)        |       (24.1)       (27.4)       (25.1)       (24.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            NAPHTHALENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        10 PPM           = 2
                                                        30 PPM           = 3
                                                        30 PPM           = 4

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

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

      |
      |
  100 + 1 21                                        3
      |   21  2 1                                   3   3                             43                 4
      |       2 1    1     2                      2                                    3           3     4  43
      |                                           2  2  2                                                   43 4  4          3
   90 +                                                 2    2                                                    4   4
      |              11   1                                  2     2                         2                        44
P     |                   1   1  1                                                           2             2 2         4     4
E     |                          1    11                                                                     2   2  2
R  80 +                                1     1                                                                      22
C     |                                      1   1   1
E     |                                              1     11                                                        2       2
N     |                                                     1    1
T  70 +                                                          1   1
      |                                                              11
S     |                                                               11   1
U     |                                                                    1      1             1
R  60 +                                                                                         1     1
V     |                                                                                               1   1
I     |                                                                                                   1    1
V     |                                                                                                        1    1
A  50 +                                                                                                             11
L     |                                                                                                              11
      |                                                                                                               11
      |                                                                                                                11
   40 +                                                                                                                 11
      |                                                                                                                  11  1
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 22 obs hidden.

                                                            NAPHTHALENE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        10 PPM           = 2
                                                        30 PPM           = 3
                                                        30 PPM           = 4

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

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

      |
      |
  100 + 1          3          1       2                                    4
      |            3                  2 2                       3          4       4
      |                       1       1 2            2          3 3                4                     4
      |                               1                           3        3                      1
P  95 +                                              2                                         2         44
E     |                                                                    3      3            2  1   1   44      2
R     |                                                                           3                   1  3   1    2      2
C     |                                                                                                  3 3 141
E  90 +                                                                                                    3  31 1
N     |                                                                                                       3  1 1     2   2
T     |                                                                                                        4 4 1        1
      |                                                                                                          3 3
S  85 +                                                                                                          443 3      11
U     |                                                                                                           4  33
R     |                                                                                                              43 3
V     |
I  80 +                                                                                                               44
V     |                                                                                                                44
A     |                                                                                                                 343
L     |                                                                                                                  43 43
   75 +                                                                                                                     44
      |
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.
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