National Toxicology Program

National Toxicology Program
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TR 373 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Microbiological Assoc.                                    DATE: 09/05/94   
EXP: 05041                    SUCCINIC ANHYDRIDE               TIME: 13:27:45   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55696B   
CONT: N01ES2802601                                             CAS: 108-30-5    
PATHOLOGIST: W. HALL                                                            
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Microbiological Assoc.                                    DATE: 09/05/94  
EXP: 05041                    SUCCINIC ANHYDRIDE               TIME: 13:27:45  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55696B  
CONT: N01ES2802601                                             CAS: 108-30-5   
PATHOLOGIST: W. HALL                                                           

                                SUCCINIC ANHYDRIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 1    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      364   481   542   549   575   590   599   603   632   632                 |
 |      642   646   661   681   691   691   696   706   708   711                 |
 |      715   716   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      145                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50MG/KG LOW                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 2    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      2     279   365   451   495   550   568   575   583   598                 |
 |      619   620   634   641   641   662   676   677   690   703                 |
 |      705   714   716   716   723                                               |
 |  CENSORED DEATHS                                                               |
 |      191   620                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100MG/KGHIGH                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 4    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      68    82    96    185   463   515   533   554   570   603                 |
 |      604   625   639   662   670   679   695   698   703   711                 |
 |      711   713   719   723                                                     |
 |  CENSORED DEATHS                                                               |
 |      176   209   305   431                                                     |
 |                                                                                |
 ==================================================================================

                                SUCCINIC ANHYDRIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.3  98.3  96.6  94.9  86.4  78.0  61.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50MG/KG LOW|    98.3  98.3  98.3  94.9  94.9  93.2  91.6  83.1  72.8  57.2      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KGHIG|    96.7  95.0  93.3  93.3  93.3  91.5  87.9  80.7  75.4  57.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          50MG/KG LOW      100MG/KGHIGH  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.0%            57.2%            57.4%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.656          P=0.690          P=0.718       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       632.8            584.1            550.9         |
 |NATURAL DEATHS (C)      |       (18.4)           (33.0)           (44.0)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       682.4            657.9            627.8         |
 |(STANDARD ERROR)        |       (13.0)           (18.2)           (24.1)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                SUCCINIC ANHYDRIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 1    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      77    169   479   494   507   516   553   576   604   606                 |
 |      611   616   620   640   641   642   663   670   695   705                 |
 |      705   707   711   715   719   723   723   726                             |
 |  CENSORED DEATHS                                                               |
 |      9                                                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50MG/KG LOW                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 26     CENSORED DEATHS 7    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      2     2     11    169   187   401   471   541   590   599                 |
 |      603   606   606   617   620   642   677   684   689   691                 |
 |      695   705   723   723   723   723                                         |
 |  CENSORED DEATHS                                                               |
 |      5     9     9     9     10    12    13                                    |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 100MG/KG HIGH                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 9    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      198   225   337   353   365   417   503   563   586   606                 |
 |      606   619   625   629   642   663   674   678   705   711                 |
 |      720   720   726   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      5     5     9     9     111   170   176   200   283                       |
 |                                                                                |
 ==================================================================================

                                SUCCINIC ANHYDRIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.3  96.6  96.6  96.6  96.6  94.9  89.8  84.7  71.2  52.5      |
 |           |                                                                    |
 |           |                                                                    |
 |50MG/KG LOW|    94.8  92.9  91.0  91.0  89.2  87.3  85.4  79.7  70.2  51.2      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0  96.2  90.3  88.3  88.3  86.4  82.4  68.7  53.0      |
 |HIGH       |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          50MG/KG LOW      100MG/KG      |
 |                                                                  HIGH          |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       52.5%            51.2%            53.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000          P=0.873          P=1.000       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       600.5            526.9            566.5         |
 |NATURAL DEATHS (C)      |       (29.2)           (47.3)           (33.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       657.0            557.5            570.8         |
 |(STANDARD ERROR)        |       (19.3)           (35.1)           (30.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                         SUCCINIC ANHYDRIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        50MG/KG LOW      = 2
                                                        100MG/KGHIGH     = 3

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

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

      |
      |
  100 + 12         3                                             1
      |  2         3 3                              2            1                  1
      |
      |              3 3                            2             2                 1         1
   95 +                3              3                           2             2             11
      |                               3                                         2 3   2        1   1
      |
      |                                                                           3   2  3     2   1  1
   90 +                                                                                  3   3 2  2   11
      |                                                                                           22   11
P     |                                                                                      3  3
E     |                                                                                         3 322   1   1
R  85 +                                                                                             2  2
C     |                                                                                           3     3
E     |                                                                                                2  2 11
N     |                                                                                                 3  3 11
T  80 +                                                                                                   2 2 1  1
      |                                                                                                    3 3
S     |                                                                                                     22   1  1
U     |                                                                                                             11
R  75 +                                                                                                      2   23
V     |                                                                                                           33
I     |                                                                                                          2 2 11
V     |                                                                                                            3  11
A  70 +                                                                                                                11
L     |                                                                                                            2 233
      |                                                                                                              2 2
      |                                                                                                                311
   65 +
      |                                                                                                                22
      |                                                                                                                 211
      |                                                                                                                 331 1
   60 +
      |                                                                                                                  22
      |                                                                                                                   2 2
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 12 obs hidden.

                                                         SUCCINIC ANHYDRIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        50MG/KG LOW      = 2
                                                        100MG/KG HIGH    = 3

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

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

      |
      |
  100 + 12          1                   3
      |             1               1
      |                                 3   3
      |  22                         1       3                 3                     1
   95 +   2                         2                                               1 1
      |                                                       3 3                     1 1
      |                             2 2                         3 3
      |                               2                                 2               11
   90 +                                                           3       3              1     1
      |                                                                 2 3        2   3       1   1
      |                                                                            2          2
      |                                                                                3         3 1    1
P  85 +                                                                                       2  3  3 2
E     |                                                                                               22
R     |                                                                                             3   11
C     |                                                                                                22
E  80 +                                                                                                  11
N     |                                                                                                 3 3
T     |                                                                                                   1  1
      |                                                                                                 2 23
S  75 +
U     |
R     |                                                                                                   23 1   1
V     |                                                                                                      3   11
I  70 +                                                                                                      2    12  1
V     |                                                                                                          3 22
A     |                                                                                                               11
L     |                                                                                                             22
   65 +                                                                                                            3   3
      |
      |                                                                                                              2211
      |                                                                                                               2211
   60 +
      |                                                                                                                2  2
      |                                                                                                                  11
      |
   55 +
      |
      |                                                                                                                   1 1
      |                                                                                                                   2 2
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 16 obs hidden.

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