National Toxicology Program

National Toxicology Program
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TDMS Study 05002-05 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/02/94   
EXP: 05002                   GAMMA-BUTYROLACTONE               TIME: 18:11:30   
TEST: 05              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55878    
CONT: NO1CP9565101                                             CAS: 96-48-0     
PATHOLOGIST: R. THOMPSON                     S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/02/94  
EXP: 05002                   GAMMA-BUTYROLACTONE               TIME: 18:11:30  
TEST: 05              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55878   
CONT: NO1CP9565101                                             CAS: 96-48-0    
PATHOLOGIST: R. THOMPSON                     S. EUSTIS                         

                                GAMMA-BUTYROLACTONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 1    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      465   469   481   481   498   529   570   574   575   577                 |
 |      580   596   618   624   641   651   663   664   668   668                 |
 |      674   681   700   708   714                                               |
 |  CENSORED DEATHS                                                               |
 |      543                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 112.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 3    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      392   399   489   529   533   571   588   590   593   617                 |
 |      618   640   658   674   689   690   708   712   718   721                 |
 |  CENSORED DEATHS                                                               |
 |      381   555   645                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 225.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 3    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   529   550   561   577   581   609   661   663   667                 |
 |      668   669   695   726   727                                               |
 |  CENSORED DEATHS                                                               |
 |      365   703   704                                                           |
 |                                                                                |
 ==================================================================================

                                GAMMA-BUTYROLACTONE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  92.0  88.0  75.7  63.4  49.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |112.       |   100.0 100.0 100.0 100.0  95.9  95.9  89.8  81.4  73.0  58.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |225.       |   100.0 100.0 100.0 100.0  98.0  98.0  95.9  87.8  81.6  69.1      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          112.             225.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       49.1%            58.0%            69.1%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.043N         P=0.415N         P=0.053N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       602.8            606.5            619.8         |
 |NATURAL DEATHS (C)      |       (15.9)           (22.1)           (22.0)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       662.2            667.9            687.9         |
 |(STANDARD ERROR)        |       (12.1)           (13.7)           (11.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                GAMMA-BUTYROLACTONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      316   498   512   512   542   556   556   559   574   651                 |
 |      663   666   667   667   667   668   683   688   690   702                 |
 |      716   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 225.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      287   337   366   376   417   501   511   569   641   652                 |
 |      678   682   682   689   689   690   700   702   708   708                 |
 |      710   711   716                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 450.    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 2    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      148   220   221   325   452   574   578   584   596   596                 |
 |      599   653   668   669   670   670   677   687   726   726                 |
 |  CENSORED DEATHS                                                               |
 |      141   569                                                                 |
 |                                                                                |
 ==================================================================================

                                GAMMA-BUTYROLACTONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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  98.0  98.0  98.0  90.0  82.0  78.0  56.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |225.       |   100.0 100.0 100.0  96.0  90.0  90.0  86.0  84.0  80.0  54.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |450.       |   100.0  98.0  93.9  91.8  91.8  89.8  89.8  77.3  75.2  58.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          225.             450.          |
 |                                CONTROL          MG/KG            MG/KG         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.0%            54.0%            58.5%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.927N         P=1.000          P=0.969N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       612.7            596.6            552.0         |
 |NATURAL DEATHS (C)      |       (21.0)           (29.9)           (40.1)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       678.4            668.6            643.8         |
 |(STANDARD ERROR)        |       (12.3)           (16.6)           (22.6)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

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

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

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

      |
      |
  100 + 1                                                             2   3       1
      |                                                               22  3                 3
      |                                                                2          1 12      2  3 3
      |                                                                             1  1    22   3 3
P  90 +                                                                                1    12    2
E     |                                                                                     1     132   3
R     |                                                                                           112 2 3        3
C     |                                                                                               2   2      33
E  80 +
N     |                                                                                            1   1  2  2
T     |                                                                                                1  1  2 2  3   3
      |                                                                                                   11 1 2   2  3   3
S  70 +                                                                                                      11    2 2    3 3
U     |                                                                                                       1  1   2  2
R     |
V     |                                                                                                          11     22
I  60 +                                                                                                           11
V     |                                                                                                            11    2  2
A     |                                                                                                             1 1
L     |                                                                                                               1 1
   50 +                                                                                                                 1   1
      |
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.

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

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

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

      |
      |
  100 + 1                       3                    2     1
      |
      |                         3          3         2     1  2                        1
      |                                                       2   2                    1 1
   95 +
      |                                    3                3     22
      |                                                            2      2              1    1
      |                                                     3                   3
   90 +                                                                   2     3      2      1 1 3
      |
      |                                                                                22         33
      |                                                                                 2         2
P  85 +                                                                                            33
E     |                                                                                         1 1 3  3     2
R     |                                                                                           1          212
C     |
E  80 +                                                                                                       12 1 2
N     |
T     |                                                                                                3       3 1122
      |
S  75 +                                                                                                        3  3
U     |                                                                                                             22
R     |
V     |
I  70 +
V     |
A     |                                                                                                           1 122
L     |                                                                                                           331122
   65 +                                                                                                            3 3
      |                                                                                                                22
      |                                                                                                              1 1  3
      |
   60 +                                                                                                                1 1
      |                                                                                                                   3 3
      |                                                                                                                  11
      |                                                                                                                 221 1
   55 +
      |                                                                                                                  2  2
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.
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