National Toxicology Program

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TR 393 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/17/94   
EXP: 05131                     SODIUM FLUORIDE                 TIME: 04:25:03   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 55221B   
CONT: N01-ES-55102                                             CAS: 7681-49-4   
PATHOLOGIST: R. PERSING                      S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/17/94  
EXP: 05131                     SODIUM FLUORIDE                 TIME: 04:25:03  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 55221B  
CONT: N01-ES-55102                                             CAS: 7681-49-4  
PATHOLOGIST: R. PERSING                      S. EUSTIS                         

                                  SODIUM FLUORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 99     UNCENSORED DEATHS 38     CENSORED DEATHS 19   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      59    145   325   417   441   533   543   543   543   549                 |
 |      570   570   571   599   613   644   645   646   648   656                 |
 |      665   669   676   677   684   686   690   692   694   697                 |
 |      712   716   718   718   718   719   719   726                             |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   184   185   185   185   185   185                 |
 |      459   459   459   459   459   459   460   460   460                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = SPECIAL CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 27   TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      180   317   389   414   537   537   555   607   613   614                 |
 |      620   627   634   645   670   680   695   716                             |
 |  CENSORED DEATHS                                                               |
 |      282   382   388   404   422   441   464   501   522   526                 |
 |      533   544   561   570   575   584   591   602   641   644                 |
 |      655   660   677   691   705   710   726                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 26     CENSORED DEATHS 19   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      422   424   533   584   607   623   634   638   647   654                 |
 |      663   668   669   670   671   673   676   691   697   699                 |
 |      706   710   711   717   718   727                                         |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   184   185   185   185   185   185                 |
 |      459   459   459   459   459   459   460   460   460                       |
 |                                                                                |
 ==================================================================================

                                  SODIUM FLUORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 26     CENSORED DEATHS 21   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      382   404   570   575   583   591   603   607   607   619                 |
 |      642   648   660   668   681   681   684   693   698   702                 |
 |      715   715   716   717   718   718                                         |
 |  CENSORED DEATHS                                                               |
 |      184   184   185   185   185   185   185   185   185   185                 |
 |      185   459   459   460   460   460   460   460   460   460                 |
 |      460                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 175 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 100    UNCENSORED DEATHS 38     CENSORED DEATHS 20   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      282   388   389   464   501   522   526   544   561   570                 |
 |      587   602   607   614   620   628   645   646   646   655                 |
 |      659   661   661   664   671   678   681   681   683   683                 |
 |      687   695   710   711   718   718   726   726                             |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   184   184   184   184   185   190                 |
 |      459   459   459   459   459   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                                  SODIUM FLUORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE 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 PPM      |    99.0  98.0  98.0  96.9  95.7  94.6  89.6  83.2  74.4  53.0      |
 |           |                                                                    |
 |           |                                                                    |
 |SPECIAL    |   100.0  98.0  98.0  96.0  91.6  91.6  86.4  83.7  59.9  39.3      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 PPM     |   100.0 100.0 100.0 100.0  96.7  96.7  94.7  92.7  78.9  49.3      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0 100.0  96.6  96.6  96.6  86.3  74.0  47.3      |
 |           |                                                                    |
 |           |                                                                    |
 |175 PPM    |   100.0 100.0 100.0  98.9  96.7  95.4  90.4  85.4  70.3  52.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  SODIUM FLUORIDE


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


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              SPECIAL            25 PPM             100 PPM            175 PPM          |
 |                                                   CONTROL                                                                   |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       53.0%              39.3%              49.3%              47.3%              52.7%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.680N            -----             P=0.923            P=0.746            P=1.000          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       600.9              558.3              647.4              638.3              616.1            |
 |NATURAL DEATHS (C)      |       (24.5)             (34.0)             (15.6)             (17.2)             (16.7)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       600.3              573.9              586.2              571.4              604.7            |
 |(STANDARD ERROR)        |       (18.9)             (18.5)             (22.9)             (23.4)             (17.5)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                  SODIUM FLUORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 100    UNCENSORED DEATHS 21     CENSORED DEATHS 20   TERMINAL 59        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      260   376   400   463   509   620   630   634   643   646                 |
 |      647   663   674   677   682   683   683   691   710   719                 |
 |      719                                                                       |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   184   184   184   185   185   185                 |
 |      459   459   459   459   459   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = SPECIAL CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 21   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      320   379   402   599   609   620   632   633   646   670                 |
 |      716                                                                       |
 |  CENSORED DEATHS                                                               |
 |      338   415   451   463   515   557   561   568   579   584                 |
 |      614   628   641   643   643   661   677   698   705   710                 |
 |      726                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 PPM                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 19     CENSORED DEATHS 20   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      451   565   582   618   620   631   639   659   677   677                 |
 |      696   702   704   709   715   718   719   719   719                       |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   185   185   185   185   185   185                 |
 |      459   459   459   459   459   459   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                                  SODIUM FLUORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      568   568   571   575   643   646   647   647   647   662                 |
 |      663   670   708   715   716   716                                         |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   184   185   185   185   185   185                 |
 |      459   459   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 175 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 100    UNCENSORED DEATHS 27     CENSORED DEATHS 19   TERMINAL 54        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      338   415   515   557   561   571   578   613   628   631                 |
 |      631   639   646   647   647   647   678   705   709   714                 |
 |      716   716   716   719   719   719   722                                   |
 |  CENSORED DEATHS                                                               |
 |      184   184   184   184   185   185   185   185   185   185                 |
 |      459   459   459   459   459   459   460   460   460                       |
 |                                                                                |
 ==================================================================================

                                  SODIUM FLUORIDE


                       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 PPM      |   100.0 100.0  98.9  98.9  96.7  95.4  94.2  94.2  85.4  74.1      |
 |           |                                                                    |
 |           |                                                                    |
 |SPECIAL    |   100.0 100.0 100.0  98.0  93.9  93.9  93.9  91.4  77.8  71.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 PPM     |   100.0 100.0 100.0 100.0 100.0  98.3  98.3  94.3  84.3  62.2      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  92.0  78.0  68.0      |
 |           |                                                                    |
 |           |                                                                    |
 |175 PPM    |   100.0 100.0 100.0  98.9  97.8  97.8  96.5  91.6  80.5  66.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================

                                  SODIUM FLUORIDE


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


 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 PPM              SPECIAL            25 PPM             100 PPM            175 PPM          |
 |                                                   CONTROL                                                                   |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.1%              71.0%              62.2%              68.0%              66.8%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.681             -----             P=0.285            P=0.630            P=0.442          |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       606.1              566.0              658.9              647.6              633.2            |
 |NATURAL DEATHS (C)      |       (27.8)             (40.1)             (16.1)             (13.3)             (18.4)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       621.8              634.5              593.7              594.2              624.4            |
 |(STANDARD ERROR)        |       (17.9)             (16.3)             (23.2)             (23.0)             (17.4)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    


       (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)

                                                          SODIUM FLUORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        SPECIAL CONTROL  = 2
                                                        25 PPM           = 3
                                                        100 PPM          = 4
                                                        175 PPM          = 5

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

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

      |
      |
  100 + 1         1            1     2               5               45    3
      |                        1     2                     21        45 4 13      5          3    4
      |                                                    2          2   1  1    5    5   5 1    443
      |                                                                   2                5511    43   3
P  90 +                                                                                       11 55 4 4 3 3 3
E     |                                                                                      2 12 1 5 454   33
R     |                                                                                           1    155   33
C     |                                                                                         2      12145 133
E  80 +                                                                                                 2245 113 33
N     |                                                                                                      411
T     |                                                                                                       41 11
      |                                                                                                  22       114
S  70 +                                                                                                   22     5311
U     |                                                                                                    22      311
R     |                                                                                                             411
V     |                                                                                                     2 2     541411
I  60 +                                                                                                       2   2   3334
V     |                                                                                                                 55
A     |                                                                                                           2 2   311
L     |                                                                                                                  31 1
   50 +                                                                                                             2 2   3 3
      |                                                                                                                  4  4
      |                                                                                                               2  2
      |
   40 +                                                                                                                  2  2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 68 obs hidden.

                                                          SODIUM FLUORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        SPECIAL CONTROL  = 2
                                                        25 PPM           = 3
                                                        100 PPM          = 4
                                                        175 PPM          = 5

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

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

      |
      |
  100 + 1                                         1        2  5                 3                 4
      |                                           1           5    1      5     3                3
      |                                                    2       1 2  1 5              5
      |                                                              2  1         1      5      53  3
   95 +                                                                           1     1       55
      |                                                                 2               1        5443  2  1
      |                                                                                           54      11 4
      |                                                                                            5   225 11
P  90 +                                                                                                  535114
E     |                                                                                                 2 25311
R     |
C     |                                                                                                   2 231  1
E  85 +                                                                                                      55  1 1
N     |                                                                                                          3 3
T     |                                                                                                       4  4 11
      |                                                                                                     2 2
S  80 +                                                                                                       5    3  3
U     |                                                                                                            51133
R     |                                                                                                       2  42  1 51
V     |                                                                                                           4     11
I  75 +                                                                                                           2     52
V     |                                                                                                                331  1
A     |                                                                                                                 33
L     |                                                                                                                  2  2
   70 +
      |
      |                                                                                                                  45 4
      |                                                                                                                   5 5
   65 +
      |
      |                                                                                                                  3  3
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 24 obs hidden.

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