National Toxicology Program

National Toxicology Program
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TDMS Study 05002-06 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/02/94   
EXP: 05002                   GAMMA-BUTYROLACTONE               TIME: 20:03:52   
TEST: 06              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55878    
CONT: NO1CP9565101                                             CAS: 96-48-0     
PATHOLOGIST: J. HEATH                                                           
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REASONS FOR REMOVAL:                                                            
                                                                                
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/02/94  
EXP: 05002                   GAMMA-BUTYROLACTONE               TIME: 20:03:52  
TEST: 06              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55878   
CONT: NO1CP9565101                                             CAS: 96-48-0    
PATHOLOGIST: J. HEATH                                                          

                                GAMMA-BUTYROLACTONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      175   385   441   473   473   540   578   582   582   601                 |
 |      618   633   688   703   721                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 262.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      132   146   151   187   270   344   380   391   391   401                 |
 |      412   436   519   532   584   584   605   613   656   670                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 525.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 37     CENSORED DEATHS 1    TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      67    108   119   119   119   159   169   169   170   171                 |
 |      185   188   192   329   381   385   427   431   445   512                 |
 |      514   545   568   568   568   583   585   585   597   601                 |
 |      640   652   655   656   657   690   703                                   |
 |  CENSORED DEATHS                                                               |
 |      93                                                                        |
 |                                                                                |
 ==================================================================================

                                GAMMA-BUTYROLACTONE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0  98.0  98.0  98.0  96.0  90.0  88.0  80.0  76.0  70.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |262.       |   100.0  94.0  90.0  88.0  78.0  76.0  72.0  66.0  62.0  60.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |525.       |    98.0  79.6  73.5  71.5  67.4  61.3  55.1  38.8  28.6  24.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          262.             525.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%            60.0%            24.5%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001          P=0.257          P<0.001       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       546.2            420.2            411.1         |
 |NATURAL DEATHS (C)      |       (36.5)           (39.2)           (35.2)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       674.2            605.5            481.1         |
 |(STANDARD ERROR)        |       (16.0)           (26.5)           (33.3)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                GAMMA-BUTYROLACTONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      581   584   586   592   609   610   611   617   630   655                 |
 |      673   697                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 262.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      464   477   527   551   560   591   591   592   592   617                 |
 |      624   630   633   633   641   690                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 525.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      471   511   592   592   641   643   655   656   656   693                 |
 |      708   711                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                GAMMA-BUTYROLACTONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  92.0  80.0  76.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |262.       |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  82.0  70.0  68.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |525.       |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  82.0  76.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          262.             525.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       76.0%            68.0%            76.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.997N         P=0.436          P=1.000N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       620.4            588.3            627.4         |
 |NATURAL DEATHS (C)      |       (10.7)           (15.1)           (21.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       703.7            684.7            705.4         |
 |(STANDARD ERROR)        |       ( 7.1)           (10.6)           ( 8.0)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                        GAMMA-BUTYROLACTONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        262.    MG/KG    = 2
                                                        525.    MG/KG    = 3

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

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

      |
      |
  100 + 1          3         2      1
      |            3      3  2 2    1                                1
      |                   33   22     2                              1       1     1
      |                               2            2
   90 +                    3     3                 2           2                   1          1
      |                          3  3                          2     2                        1    1
      |                                                              22                            11
      |                                                               2 2                           1  1
P  80 +                             3 3                                 22                             1  1
E     |                                                                  2   2                            1 1
R     |                               33                                     2             22               1        1 1
C     |                                3                    3        3                      2       2                  1 1
E  70 +                                                                                                                  1  1
N     |                                                              3     3                        2   2
T     |                                                                    33                           22     2
      |                                                                     3 3          3                     2  2
S  60 +                                                                                                           2         2
U     |                                                                                  3    3
R     |                                                                                       3   3
V     |
I  50 +                                                                                           3 3
V     |
A     |
L     |                                                                                             3  3
   40 +                                                                                                3     3
      |                                                                                                      3 3
      |
      |
   30 +
      |                                                                                                        3     3 3
      |                                                                                                                3    3
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.

                                                        GAMMA-BUTYROLACTONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        262.    MG/KG    = 2
                                                        525.    MG/KG    = 3

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

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

      |
      |
  100 + 1                                                                         23               1
      |
      |                                                                           232   3          11
      |                                                                             2   3   2         3
   95 +
      |                                                                                     2  2    1 1
P     |                                                                                        22     1 1    3
E     |
R  90 +                                                                                         2     2 11
C     |
E     |                                                                                                      3 3
N     |                                                                                                  11
T  85 +
      |                                                                                                   11
S     |                                                                                               2   21   1     3
U     |
R  80 +                                                                                                   22   1   1 3  3
V     |
I     |                                                                                                            1  1
V     |                                                                                                    22         1 3   1
A  75 +
L     |
      |                                                                                                     22
      |
   70 +                                                                                                      2       2
      |
      |                                                                                                              2      2
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.
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